Combination Therapy with Anti-inflammatory Dose Doxycycline and Metronidazole 1% Gel More Effective than Metronidazole 1% Gel Alone
In a double-blind, placebo-controlled, multicenter trial of rosacea patients, those who received treatment with a combination of anti-inflammatory-dose doxycycline (doxycycline monohydrate delayed-release 40-mg capsules) (Oracea) and 1% metronidazole (MetroGel) — as compared to those who were treated with 1% MetroGel and placebo — experienced a significantly better mean change in number of inflammatory lesions. Patients in the Oracea and MetroGel group experienced a mean reduction of 13.9 inflammatory lesions, compared to 8.5 in the placebo and MetroGel group.
The improvements these study participants experienced were seen as early as week 4 of the 16-week study and continued to outpace the MetroGel and placebo group at all follow-up points — weeks 4, 8, 12 and 16.
A Closer Look
In the study, which included 72 patients who had rosacea, participants received the designated therapy once a day for 12 weeks. Then at week 12, MetroGel was discontinued, and patients continued to receive either Oracea or placebo through week 16.
The primary efficacy endpoint of the study was the mean change in inflammatory lesions at weeks 12 and 16. The results were as follows:
• At baseline, the patients in the Oracea and MetroGel group had a mean total inflammatory lesion count of 21.3. At week 12, this group experienced a reduction in inflammatory lesions of 13.9.
• In the placebo and MetroGel patient group, the baseline mean total inflammatory lesion count was 18.7. At week 12, this group experienced a reduction of 8.5 inflammatory lesions. The difference between the two groups was statistically significant (p=0.002).
• The mean percent reduction in inflammatory lesions was 66.4% in the Oracea and MetroGel group compared to 48.2% in the placebo and MetroGel group (p=0.008).
• The difference in the inflammatory lesion count reduction was statistically significant as early as week 4, when patients undergoing treatment with the Oracea and MetroGel combination therapy demonstrated a reduction in inflammatory lesions of 9.7 while the group receiving placebo and MetroGel demonstrated a reduction in inflammatory lesions of 2.9 (p=0.0008).
Adverse events that occurred during this study were mild, and both treatment groups experienced similar events.
Maintenance Therapy
At week 16, after MetroGel had been discontinued for
4 weeks, the patients treated with Oracea alone generally maintained their level of improvement, while the improvement slowed in the patients on placebo.
In the Oracea group at week 16, patients experienced a mean total reduction of 13.4 inflammatory lesions compared to baseline, while the patients treated with placebo experienced a mean total reduction of 6.5 inflammatory lesions (p=0.0006).
It was concluded that the combination treatment of Oracea and MetroGel resulted in greater improvement and a faster reduction of inflammatory lesions as compared to treatment with MetroGel and placebo.
The author additionally concluded that this combination treatment should be considered for first-line therapy of rosacea.
Poster Author: Joseph F. Fowler Jr., M.D.
Evaluating Azelaic Acid 15% Gel as a Treatment for Acne
Although azelaic acid 15% gel (Finacea) is FDA approved for treating pustular rosacea and not acne vulgaris, a recent poster highlighting the results of two Phase III trials and a large observational study conducted in other countries indicated that this treatment was effective and well tolerated in treating mild to moderate acne vulgaris.
In the two Phase III studies, which were multicenter, randomized, double-blind, controlled comparative clinical studies conducted in Germany, Holland, Norway and Greece, a total of 580 patients between the two studies underwent treatment with either azelaic acid 15% gel or benzoyl peroxide 5% gel b.i.d. for 4 months (study 1) or azelaic acid 15% gel or clindamycin sulfate b.i.d. for 4 months (study 2). (See Figure 1 for details of the overall results of these studies.)
The observational study was unblinded and included 1,243 patients who were observed by 296 participating German dermatologists in private practice. In this study, patients were treated with azelaic acid 15% gel b.i.d. for 4 months.
Overall, in the three studies, the following was concluded:
• Results of both clinical and observational trials show that azelaic acid 15% gel is an effective and well-tolerated topical treatment for mild to moderate acne vulgaris.
• In controlled clinical trials, azelaic acid 15% gel had equal or better clinical efficacy than topical benzoyl peroxide or clindamycin, which attributed to azelaic acid 15% gel’s utility in treating inflammatory papulopustular acne vulgaris.
• Observational studies of patients who were seen in private practice dermatologists’ offices indicated that azelaic acid 15% gel was effective and well tolerated as a single agent or in combination with other agents. The formulation was also well accepted by patients, with 86.5% of patients electing to continue azelaic acid treatment after the study.
• Investigators concluded that azelaic acid is well suited for treating acne vulgaris. This treatment can be used as long-term therapy without reservation, according to the researchers, because of its superior tolerability and lack of phototoxic and photosensitizing effects. In addition, azelaic acid 15% gel does not induce microbial resistance, and it can be readily combined with other agents.
• On an important note, azelaic acid is not teratogenic or mutagenic, and can therefore be used in patients who are pregnant.
Poster author: Diane Thiboutot, M.D.
Combination Blue and Red Light Therapy Effective in Treating Acne
A pilot study of 22 patients found that a combination of non-thermal, non-laser, phototherapy using red and blue light therapy was a safe and efficacious treatment for acne vulgaris with patients experiencing a significant (81%) reduction in mean lesion count by the final 12-week follow-up.
Theory Behind Using Blue and Red Light in Combination
The objective of this study was to evaluate the efficacy of light-emitting diodes in a a combination of 415-nm blue and 633-nm red light in reducing inflammatory lesions in both mild, moderate and severe acne patients using a regimen of eight light treatments over 4 weeks.
Blue light: Blue light therapy (415 nm) is effective at activating coproporphyrin III and protoporphyrin IX, subsequently destroying the Propionibacterium acnes bacteria. Omnilux blue was utilized in the study to deliver a non-coherent blue light at 415 nm wavelength, 40 mW/cm2 intensity and a total dose of 48 J/cm2 after 20 minutes of exposure.
Red light: Red light (633 nm) is less effective at activating coproporphyrin III than blue light; however, it is a potent activator of protoporphyrin IX, also found in P. acnes bacteria. Because red light penetrates deeper into tissue than blue light does, it is possible that red light actively destroys P. acnes residing in the lower regions of the sebaceous gland. Another added benefit of red light is that it has anti-inflammatory properties. In this study, Omnilux revive was used to deliver non-coherent red light at a 633-nm wavelength, 80 mW/cm2 at a total dose of 96 J/cm2 after 20-minute exposure.
Treatment
In the study, 24 participants with mild to severe acne underwent eight sessions of treatment — two sessions per week 3 days apart, alternating between 415-nm blue light (20 minutes/session, 48 J/cm2) and 633-nm red light (20 minutes/session, 96 J/cm2). Each study participant also received a gentle facial wash followed by treatment with aluminium oxide crystal microdermabrasion (5-minute treatment time per full face) before each light treatment.
Patients’ acne was assessed at baseline and at weeks 2, 4, 8 and 12. The study was unblinded and no control group was used. Study participants also assessed their outcomes, as well.
Study Results
4-week follow-up. At this point, the mean lesion count reduction was significant at 46% (p=0.001).
12-week follow-up. At this time, the mean lesion count reduction was also significant at 81% (p=0.001).
Mild acne. Comparing lesion count reduction at the
12-week follow-up between participants with mild to moderate acne and those with severe acne, those with a mild to moderate condition showed a mean reduction of 81.3% (p=0.01).
Severe acne. Study participants who had severe acne exhibited a mean reduction of 82.5% (p=0.001).
For more information regarding mean lesion count reductions, see Table 1.
Patient and dermatologist assessments were similar, and neither study participants nor investigating physicians graded the overall response as “worse” or “unchanged.” Investigator and patient assessments were comparable, with most study participants (68%) assessing the treatment as having a “marked improvement” on their acne, as compared with 59% of the physicians who participated in the study. Regarding an assessment of total clearance, at 12 weeks, 9% of participants reported total clearance and the investigating dermatologists reported this effect in 14% of subjects. For a look at how more parameters compare between study participants and investigators, see Table 2.
Two participants reported mild facial erythema, which was the only side effect noted.
Although the light therapy course achieved considerable reduction in papules, pustules and nodules, comedo counts were minimally affected. This may be an indication for the addition of an anticomedonal preparation used adjunctively with light therapy treatments for acne.
Source: Goldberg DJ, Russell BA. Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to severe acne vulgaris. Journal of Cosmetic and Laser Therapy. 2006; 8: 71–75.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.”
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.” n
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Solubilized Benzoyl Peroxide (BP) Gel Better Tolerated and More Effective Than Either BP Alone or in Combination Formulations Tested
A newly developed 5% solubilized benzoyl peroxide (BPO) gel with high bioavailability was recently shown to offer greater bactericidal activity against Propionibacterium acnes in the follicles and on the skin surface than either a generic 5% BPO formulation or a combination 5% BPO/clindamycin product.
Noting that BPO’s bacterial activity against P. acnes and comedolytic activity, benzoyl peroxide is theoretically highly beneficial for both inflammatory and non-inflammatory acne lesions, investigators blamed its poor solubility for hindering its ability to enter the follicles and so reach areas where P. acnes proliferate.
Split-Screen Study
Its improved efficacy with improved solubility was demonstrated in a split-screen randomized study of patients aged 12 to 40 with mild to moderate acne which compared both the efficacy and tolerability of this solubilized BPO gel (plus toner) with that of a commercially available BPO/clindamycin product.
All patients applied solubilized 5% BPO gel plus toner containing 2% salicylic acid to one of their face and a commercially available BPO/clindamycin combination product to the other twice daily for 2 weeks. They were evaluated at baseline and after weeks 1 and 2 in term of inflammatory and non-inflammatory lesion count; the were also assessed for tolerability evidences such as dryness and erythema.
Better Lesion Count Reductions
The solubilized BPO regimen resulted in greater and more rapid reductions in lesion counts than the BPO/clindamycin regimen (Figure). While there were no serious adverse events, 4 of 34 patients complained of typical BPO side effects such mild burning, dryness, stinging, erythema, swelling, and itching; one reported a rash.
Poster authors: David C. Wilson, M.D., Kappa P Meadows, M.D., Jose Ramirez, Ph.D.
Is Ethnicity a Factor in Acne Patients’ Response to Therapy?
Using data compiled from the Measuring Acne Outcomes in a Real-world Experience (MORE) trial, a group of New York dermatologists gauged differences in the response of ethnic skin to different acne treatments.
Their poster, which was presented at the recent AAD meeting in Washington, D.C., underscored the special challenges involved in treating people of color with acne. Darker skin, with its clinical and histopathological differences compared with white skin, was highlighted because of its higher propensity toward post-inflammatory hyperpigmentation.
Patients and Methods
Investigators examined data compiled on 1,979 patients treated with adapalene.
These patients used a variety of adapalene 0.1% gel-containing regimens for a period of 12 weeks. Among these regimens were adapalene with benzoyl peroxide/antibiotic and adapalene with oral antibiotics among several others. Assessments were made at baseline, week 6 and week 12.
Reported findings related to ethnic skin were based on a subgroup analysis which statistically compared the following races: Asian, Hispanic, Black, American Indian/Alaskan Native Pacific Islander/other.
Similar Tolerability
While those in all racial groups demonstrated similar cutaneous tolerability to adapalene-containing combination regimens, efficacy findings did reflect notable differences.
Black and Hispanic patients showed significantly better improvement in inflammatory lesions compared to white patients.
Asian patients had higher IGA percent success at week 6 and 12 in comparison to all races.
However, overall there were no significant differences in total lesion reduction found among the different racial groups at any point in the study.
Poster authors: Fran E. Cook-Bolden, M.D., Luz E. Colon, M.S.; Sheila C. Gardner, M.S.; and Lori A. Johnson, Ph.D.
Study Finds No Benefit in Switching from One Retinoid to Another After 6 Weeks
Doctors who switch patients from one topical retinoid to another in hopes of achieving faster improvement can abandon the practice, which has been found to offer no clinical benefit in a recent study. What’s more, it may actually impair tolerability outcomes, according to a study that compared a 12-week treatment with tazarotene 0.1% cream with a 6-week treatment with adapalene 0.1% gel followed by a
6-week treatment with tazarotene 0.1% cream.
Switching Retinoids
Topical retinoids, such as adapalene and tazarotene are considered appropriate first-line therapy, either alone or in combination with antimicrobials, for all cases of acne with the exception of the most severe. Although the two agents have similar efficacy profiles, adapalene has demonstrated a more favorable tolerability profile. Some physicians have reported using a strategy in patients complaining of slow response in which they prescribe adapalene 0.1% gel for the first 6 weeks of treatment, then switch to tazarotene.
Believing that both retinoids have a slower onset of action and that the efficacy seen by patients switched would have occurred had they remained on the original prescriptions, the practice was put to the test below, which supports the hypothesis that remaining on one retinoid for 12 weeks is as effective as switching after 6 weeks.
Patients and Methods
This was a randomized, evaluator-blinded, multicenter trial to evaluate and compare the efficacy and safety of three treatment regimens: adapalene 0.1% gel daily for 12 weeks; tazarotene 0.1% cream daily for 12 weeks; and adapalene 0.1% gel daily for 6 weeks followed by tazarotene 0.1% cream daily for 6 weeks.
The study involved 302 patients, both male and female between 12 and 35 years of age, with at least 20 inflammatory lesions, between 15 and 100 non-inflammatory lesions, and not more than 3 nodulocystic lesions. Patients were not allowed to have had previous topical acne therapy within the previous 4 weeks or systemic therapy within the previous 6 months before entering the study. Patients were randomized to one of the above treatment arms and evaluations were made at baseline, week 2, week 6, week 8 and week 12.
Percent change from baseline in total lesion counts at week 12 was the primary efficacy outcome, with secondary outcomes including total lesion count changes at other time points, inflammatory and noninflammatory lesion count changes and investigator global assessment of severity.
Tolerability assessments and adverse events were recorded to evaluate the safety of the treatments. Physician and patient surveys were given to collect additional information about the attitudes and opinions related to these three treatment courses.
Evaluating the Differences
There were no significant differences among the three groups for baseline severity as determined by static global severity scoring, total lesion counts or inflammatory lesion counts. The switch group has significantly more noninflammatory lesions at baseline compared to the other two treatment groups.
Efficacy outcomes for adapalene 0.1% gel and tazarotene 0.1% cream were similar, and switching retinoids midway through the treatment did not result in enhanced outcomes.
In fact, according to these findings, the switch actually impaired the tolerability of the retinoid therapy: Tolerability evaluations suggest that switching retinoids may result in increased signs and symptoms of cutaneous irritation following the switch, with more than twice as many “definitely related” adverse events occurred with tazarotene than with adapalene.
Poster authors; Diane M. Thiboutot, M.D., Luz E. Colon, M.S., Lori A. Johnson, Ph.D., Ron W Gottschalk, M.D.
Combination Therapy with Anti-inflammatory Dose Doxycycline and Metronidazole 1% Gel More Effective than Metronidazole 1% Gel Alone
In a double-blind, placebo-controlled, multicenter trial of rosacea patients, those who received treatment with a combination of anti-inflammatory-dose doxycycline (doxycycline monohydrate delayed-release 40-mg capsules) (Oracea) and 1% metronidazole (MetroGel) — as compared to those who were treated with 1% MetroGel and placebo — experienced a significantly better mean change in number of inflammatory lesions. Patients in the Oracea and MetroGel group experienced a mean reduction of 13.9 inflammatory lesions, compared to 8.5 in the placebo and MetroGel group.
The improvements these study participants experienced were seen as early as week 4 of the 16-week study and continued to outpace the MetroGel and placebo group at all follow-up points — weeks 4, 8, 12 and 16.
A Closer Look
In the study, which included 72 patients who had rosacea, participants received the designated therapy once a day for 12 weeks. Then at week 12, MetroGel was discontinued, and patients continued to receive either Oracea or placebo through week 16.
The primary efficacy endpoint of the study was the mean change in inflammatory lesions at weeks 12 and 16. The results were as follows:
• At baseline, the patients in the Oracea and MetroGel group had a mean total inflammatory lesion count of 21.3. At week 12, this group experienced a reduction in inflammatory lesions of 13.9.
• In the placebo and MetroGel patient group, the baseline mean total inflammatory lesion count was 18.7. At week 12, this group experienced a reduction of 8.5 inflammatory lesions. The difference between the two groups was statistically significant (p=0.002).
• The mean percent reduction in inflammatory lesions was 66.4% in the Oracea and MetroGel group compared to 48.2% in the placebo and MetroGel group (p=0.008).
• The difference in the inflammatory lesion count reduction was statistically significant as early as week 4, when patients undergoing treatment with the Oracea and MetroGel combination therapy demonstrated a reduction in inflammatory lesions of 9.7 while the group receiving placebo and MetroGel demonstrated a reduction in inflammatory lesions of 2.9 (p=0.0008).
Adverse events that occurred during this study were mild, and both treatment groups experienced similar events.
Maintenance Therapy
At week 16, after MetroGel had been discontinued for
4 weeks, the patients treated with Oracea alone generally maintained their level of improvement, while the improvement slowed in the patients on placebo.
In the Oracea group at week 16, patients experienced a mean total reduction of 13.4 inflammatory lesions compared to baseline, while the patients treated with placebo experienced a mean total reduction of 6.5 inflammatory lesions (p=0.0006).
It was concluded that the combination treatment of Oracea and MetroGel resulted in greater improvement and a faster reduction of inflammatory lesions as compared to treatment with MetroGel and placebo.
The author additionally concluded that this combination treatment should be considered for first-line therapy of rosacea.
Poster Author: Joseph F. Fowler Jr., M.D.
Evaluating Azelaic Acid 15% Gel as a Treatment for Acne
Although azelaic acid 15% gel (Finacea) is FDA approved for treating pustular rosacea and not acne vulgaris, a recent poster highlighting the results of two Phase III trials and a large observational study conducted in other countries indicated that this treatment was effective and well tolerated in treating mild to moderate acne vulgaris.
In the two Phase III studies, which were multicenter, randomized, double-blind, controlled comparative clinical studies conducted in Germany, Holland, Norway and Greece, a total of 580 patients between the two studies underwent treatment with either azelaic acid 15% gel or benzoyl peroxide 5% gel b.i.d. for 4 months (study 1) or azelaic acid 15% gel or clindamycin sulfate b.i.d. for 4 months (study 2). (See Figure 1 for details of the overall results of these studies.)
The observational study was unblinded and included 1,243 patients who were observed by 296 participating German dermatologists in private practice. In this study, patients were treated with azelaic acid 15% gel b.i.d. for 4 months.
Overall, in the three studies, the following was concluded:
• Results of both clinical and observational trials show that azelaic acid 15% gel is an effective and well-tolerated topical treatment for mild to moderate acne vulgaris.
• In controlled clinical trials, azelaic acid 15% gel had equal or better clinical efficacy than topical benzoyl peroxide or clindamycin, which attributed to azelaic acid 15% gel’s utility in treating inflammatory papulopustular acne vulgaris.
• Observational studies of patients who were seen in private practice dermatologists’ offices indicated that azelaic acid 15% gel was effective and well tolerated as a single agent or in combination with other agents. The formulation was also well accepted by patients, with 86.5% of patients electing to continue azelaic acid treatment after the study.
• Investigators concluded that azelaic acid is well suited for treating acne vulgaris. This treatment can be used as long-term therapy without reservation, according to the researchers, because of its superior tolerability and lack of phototoxic and photosensitizing effects. In addition, azelaic acid 15% gel does not induce microbial resistance, and it can be readily combined with other agents.
• On an important note, azelaic acid is not teratogenic or mutagenic, and can therefore be used in patients who are pregnant.
Poster author: Diane Thiboutot, M.D.
Combination Blue and Red Light Therapy Effective in Treating Acne
A pilot study of 22 patients found that a combination of non-thermal, non-laser, phototherapy using red and blue light therapy was a safe and efficacious treatment for acne vulgaris with patients experiencing a significant (81%) reduction in mean lesion count by the final 12-week follow-up.
Theory Behind Using Blue and Red Light in Combination
The objective of this study was to evaluate the efficacy of light-emitting diodes in a a combination of 415-nm blue and 633-nm red light in reducing inflammatory lesions in both mild, moderate and severe acne patients using a regimen of eight light treatments over 4 weeks.
Blue light: Blue light therapy (415 nm) is effective at activating coproporphyrin III and protoporphyrin IX, subsequently destroying the Propionibacterium acnes bacteria. Omnilux blue was utilized in the study to deliver a non-coherent blue light at 415 nm wavelength, 40 mW/cm2 intensity and a total dose of 48 J/cm2 after 20 minutes of exposure.
Red light: Red light (633 nm) is less effective at activating coproporphyrin III than blue light; however, it is a potent activator of protoporphyrin IX, also found in P. acnes bacteria. Because red light penetrates deeper into tissue than blue light does, it is possible that red light actively destroys P. acnes residing in the lower regions of the sebaceous gland. Another added benefit of red light is that it has anti-inflammatory properties. In this study, Omnilux revive was used to deliver non-coherent red light at a 633-nm wavelength, 80 mW/cm2 at a total dose of 96 J/cm2 after 20-minute exposure.
Treatment
In the study, 24 participants with mild to severe acne underwent eight sessions of treatment — two sessions per week 3 days apart, alternating between 415-nm blue light (20 minutes/session, 48 J/cm2) and 633-nm red light (20 minutes/session, 96 J/cm2). Each study participant also received a gentle facial wash followed by treatment with aluminium oxide crystal microdermabrasion (5-minute treatment time per full face) before each light treatment.
Patients’ acne was assessed at baseline and at weeks 2, 4, 8 and 12. The study was unblinded and no control group was used. Study participants also assessed their outcomes, as well.
Study Results
4-week follow-up. At this point, the mean lesion count reduction was significant at 46% (p=0.001).
12-week follow-up. At this time, the mean lesion count reduction was also significant at 81% (p=0.001).
Mild acne. Comparing lesion count reduction at the
12-week follow-up between participants with mild to moderate acne and those with severe acne, those with a mild to moderate condition showed a mean reduction of 81.3% (p=0.01).
Severe acne. Study participants who had severe acne exhibited a mean reduction of 82.5% (p=0.001).
For more information regarding mean lesion count reductions, see Table 1.
Patient and dermatologist assessments were similar, and neither study participants nor investigating physicians graded the overall response as “worse” or “unchanged.” Investigator and patient assessments were comparable, with most study participants (68%) assessing the treatment as having a “marked improvement” on their acne, as compared with 59% of the physicians who participated in the study. Regarding an assessment of total clearance, at 12 weeks, 9% of participants reported total clearance and the investigating dermatologists reported this effect in 14% of subjects. For a look at how more parameters compare between study participants and investigators, see Table 2.
Two participants reported mild facial erythema, which was the only side effect noted.
Although the light therapy course achieved considerable reduction in papules, pustules and nodules, comedo counts were minimally affected. This may be an indication for the addition of an anticomedonal preparation used adjunctively with light therapy treatments for acne.
Source: Goldberg DJ, Russell BA. Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to severe acne vulgaris. Journal of Cosmetic and Laser Therapy. 2006; 8: 71–75.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.”
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.” n
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Solubilized Benzoyl Peroxide (BP) Gel Better Tolerated and More Effective Than Either BP Alone or in Combination Formulations Tested
A newly developed 5% solubilized benzoyl peroxide (BPO) gel with high bioavailability was recently shown to offer greater bactericidal activity against Propionibacterium acnes in the follicles and on the skin surface than either a generic 5% BPO formulation or a combination 5% BPO/clindamycin product.
Noting that BPO’s bacterial activity against P. acnes and comedolytic activity, benzoyl peroxide is theoretically highly beneficial for both inflammatory and non-inflammatory acne lesions, investigators blamed its poor solubility for hindering its ability to enter the follicles and so reach areas where P. acnes proliferate.
Split-Screen Study
Its improved efficacy with improved solubility was demonstrated in a split-screen randomized study of patients aged 12 to 40 with mild to moderate acne which compared both the efficacy and tolerability of this solubilized BPO gel (plus toner) with that of a commercially available BPO/clindamycin product.
All patients applied solubilized 5% BPO gel plus toner containing 2% salicylic acid to one of their face and a commercially available BPO/clindamycin combination product to the other twice daily for 2 weeks. They were evaluated at baseline and after weeks 1 and 2 in term of inflammatory and non-inflammatory lesion count; the were also assessed for tolerability evidences such as dryness and erythema.
Better Lesion Count Reductions
The solubilized BPO regimen resulted in greater and more rapid reductions in lesion counts than the BPO/clindamycin regimen (Figure). While there were no serious adverse events, 4 of 34 patients complained of typical BPO side effects such mild burning, dryness, stinging, erythema, swelling, and itching; one reported a rash.
Poster authors: David C. Wilson, M.D., Kappa P Meadows, M.D., Jose Ramirez, Ph.D.
Is Ethnicity a Factor in Acne Patients’ Response to Therapy?
Using data compiled from the Measuring Acne Outcomes in a Real-world Experience (MORE) trial, a group of New York dermatologists gauged differences in the response of ethnic skin to different acne treatments.
Their poster, which was presented at the recent AAD meeting in Washington, D.C., underscored the special challenges involved in treating people of color with acne. Darker skin, with its clinical and histopathological differences compared with white skin, was highlighted because of its higher propensity toward post-inflammatory hyperpigmentation.
Patients and Methods
Investigators examined data compiled on 1,979 patients treated with adapalene.
These patients used a variety of adapalene 0.1% gel-containing regimens for a period of 12 weeks. Among these regimens were adapalene with benzoyl peroxide/antibiotic and adapalene with oral antibiotics among several others. Assessments were made at baseline, week 6 and week 12.
Reported findings related to ethnic skin were based on a subgroup analysis which statistically compared the following races: Asian, Hispanic, Black, American Indian/Alaskan Native Pacific Islander/other.
Similar Tolerability
While those in all racial groups demonstrated similar cutaneous tolerability to adapalene-containing combination regimens, efficacy findings did reflect notable differences.
Black and Hispanic patients showed significantly better improvement in inflammatory lesions compared to white patients.
Asian patients had higher IGA percent success at week 6 and 12 in comparison to all races.
However, overall there were no significant differences in total lesion reduction found among the different racial groups at any point in the study.
Poster authors: Fran E. Cook-Bolden, M.D., Luz E. Colon, M.S.; Sheila C. Gardner, M.S.; and Lori A. Johnson, Ph.D.
Study Finds No Benefit in Switching from One Retinoid to Another After 6 Weeks
Doctors who switch patients from one topical retinoid to another in hopes of achieving faster improvement can abandon the practice, which has been found to offer no clinical benefit in a recent study. What’s more, it may actually impair tolerability outcomes, according to a study that compared a 12-week treatment with tazarotene 0.1% cream with a 6-week treatment with adapalene 0.1% gel followed by a
6-week treatment with tazarotene 0.1% cream.
Switching Retinoids
Topical retinoids, such as adapalene and tazarotene are considered appropriate first-line therapy, either alone or in combination with antimicrobials, for all cases of acne with the exception of the most severe. Although the two agents have similar efficacy profiles, adapalene has demonstrated a more favorable tolerability profile. Some physicians have reported using a strategy in patients complaining of slow response in which they prescribe adapalene 0.1% gel for the first 6 weeks of treatment, then switch to tazarotene.
Believing that both retinoids have a slower onset of action and that the efficacy seen by patients switched would have occurred had they remained on the original prescriptions, the practice was put to the test below, which supports the hypothesis that remaining on one retinoid for 12 weeks is as effective as switching after 6 weeks.
Patients and Methods
This was a randomized, evaluator-blinded, multicenter trial to evaluate and compare the efficacy and safety of three treatment regimens: adapalene 0.1% gel daily for 12 weeks; tazarotene 0.1% cream daily for 12 weeks; and adapalene 0.1% gel daily for 6 weeks followed by tazarotene 0.1% cream daily for 6 weeks.
The study involved 302 patients, both male and female between 12 and 35 years of age, with at least 20 inflammatory lesions, between 15 and 100 non-inflammatory lesions, and not more than 3 nodulocystic lesions. Patients were not allowed to have had previous topical acne therapy within the previous 4 weeks or systemic therapy within the previous 6 months before entering the study. Patients were randomized to one of the above treatment arms and evaluations were made at baseline, week 2, week 6, week 8 and week 12.
Percent change from baseline in total lesion counts at week 12 was the primary efficacy outcome, with secondary outcomes including total lesion count changes at other time points, inflammatory and noninflammatory lesion count changes and investigator global assessment of severity.
Tolerability assessments and adverse events were recorded to evaluate the safety of the treatments. Physician and patient surveys were given to collect additional information about the attitudes and opinions related to these three treatment courses.
Evaluating the Differences
There were no significant differences among the three groups for baseline severity as determined by static global severity scoring, total lesion counts or inflammatory lesion counts. The switch group has significantly more noninflammatory lesions at baseline compared to the other two treatment groups.
Efficacy outcomes for adapalene 0.1% gel and tazarotene 0.1% cream were similar, and switching retinoids midway through the treatment did not result in enhanced outcomes.
In fact, according to these findings, the switch actually impaired the tolerability of the retinoid therapy: Tolerability evaluations suggest that switching retinoids may result in increased signs and symptoms of cutaneous irritation following the switch, with more than twice as many “definitely related” adverse events occurred with tazarotene than with adapalene.
Poster authors; Diane M. Thiboutot, M.D., Luz E. Colon, M.S., Lori A. Johnson, Ph.D., Ron W Gottschalk, M.D.
Combination Therapy with Anti-inflammatory Dose Doxycycline and Metronidazole 1% Gel More Effective than Metronidazole 1% Gel Alone
In a double-blind, placebo-controlled, multicenter trial of rosacea patients, those who received treatment with a combination of anti-inflammatory-dose doxycycline (doxycycline monohydrate delayed-release 40-mg capsules) (Oracea) and 1% metronidazole (MetroGel) — as compared to those who were treated with 1% MetroGel and placebo — experienced a significantly better mean change in number of inflammatory lesions. Patients in the Oracea and MetroGel group experienced a mean reduction of 13.9 inflammatory lesions, compared to 8.5 in the placebo and MetroGel group.
The improvements these study participants experienced were seen as early as week 4 of the 16-week study and continued to outpace the MetroGel and placebo group at all follow-up points — weeks 4, 8, 12 and 16.
A Closer Look
In the study, which included 72 patients who had rosacea, participants received the designated therapy once a day for 12 weeks. Then at week 12, MetroGel was discontinued, and patients continued to receive either Oracea or placebo through week 16.
The primary efficacy endpoint of the study was the mean change in inflammatory lesions at weeks 12 and 16. The results were as follows:
• At baseline, the patients in the Oracea and MetroGel group had a mean total inflammatory lesion count of 21.3. At week 12, this group experienced a reduction in inflammatory lesions of 13.9.
• In the placebo and MetroGel patient group, the baseline mean total inflammatory lesion count was 18.7. At week 12, this group experienced a reduction of 8.5 inflammatory lesions. The difference between the two groups was statistically significant (p=0.002).
• The mean percent reduction in inflammatory lesions was 66.4% in the Oracea and MetroGel group compared to 48.2% in the placebo and MetroGel group (p=0.008).
• The difference in the inflammatory lesion count reduction was statistically significant as early as week 4, when patients undergoing treatment with the Oracea and MetroGel combination therapy demonstrated a reduction in inflammatory lesions of 9.7 while the group receiving placebo and MetroGel demonstrated a reduction in inflammatory lesions of 2.9 (p=0.0008).
Adverse events that occurred during this study were mild, and both treatment groups experienced similar events.
Maintenance Therapy
At week 16, after MetroGel had been discontinued for
4 weeks, the patients treated with Oracea alone generally maintained their level of improvement, while the improvement slowed in the patients on placebo.
In the Oracea group at week 16, patients experienced a mean total reduction of 13.4 inflammatory lesions compared to baseline, while the patients treated with placebo experienced a mean total reduction of 6.5 inflammatory lesions (p=0.0006).
It was concluded that the combination treatment of Oracea and MetroGel resulted in greater improvement and a faster reduction of inflammatory lesions as compared to treatment with MetroGel and placebo.
The author additionally concluded that this combination treatment should be considered for first-line therapy of rosacea.
Poster Author: Joseph F. Fowler Jr., M.D.
Evaluating Azelaic Acid 15% Gel as a Treatment for Acne
Although azelaic acid 15% gel (Finacea) is FDA approved for treating pustular rosacea and not acne vulgaris, a recent poster highlighting the results of two Phase III trials and a large observational study conducted in other countries indicated that this treatment was effective and well tolerated in treating mild to moderate acne vulgaris.
In the two Phase III studies, which were multicenter, randomized, double-blind, controlled comparative clinical studies conducted in Germany, Holland, Norway and Greece, a total of 580 patients between the two studies underwent treatment with either azelaic acid 15% gel or benzoyl peroxide 5% gel b.i.d. for 4 months (study 1) or azelaic acid 15% gel or clindamycin sulfate b.i.d. for 4 months (study 2). (See Figure 1 for details of the overall results of these studies.)
The observational study was unblinded and included 1,243 patients who were observed by 296 participating German dermatologists in private practice. In this study, patients were treated with azelaic acid 15% gel b.i.d. for 4 months.
Overall, in the three studies, the following was concluded:
• Results of both clinical and observational trials show that azelaic acid 15% gel is an effective and well-tolerated topical treatment for mild to moderate acne vulgaris.
• In controlled clinical trials, azelaic acid 15% gel had equal or better clinical efficacy than topical benzoyl peroxide or clindamycin, which attributed to azelaic acid 15% gel’s utility in treating inflammatory papulopustular acne vulgaris.
• Observational studies of patients who were seen in private practice dermatologists’ offices indicated that azelaic acid 15% gel was effective and well tolerated as a single agent or in combination with other agents. The formulation was also well accepted by patients, with 86.5% of patients electing to continue azelaic acid treatment after the study.
• Investigators concluded that azelaic acid is well suited for treating acne vulgaris. This treatment can be used as long-term therapy without reservation, according to the researchers, because of its superior tolerability and lack of phototoxic and photosensitizing effects. In addition, azelaic acid 15% gel does not induce microbial resistance, and it can be readily combined with other agents.
• On an important note, azelaic acid is not teratogenic or mutagenic, and can therefore be used in patients who are pregnant.
Poster author: Diane Thiboutot, M.D.
Combination Blue and Red Light Therapy Effective in Treating Acne
A pilot study of 22 patients found that a combination of non-thermal, non-laser, phototherapy using red and blue light therapy was a safe and efficacious treatment for acne vulgaris with patients experiencing a significant (81%) reduction in mean lesion count by the final 12-week follow-up.
Theory Behind Using Blue and Red Light in Combination
The objective of this study was to evaluate the efficacy of light-emitting diodes in a a combination of 415-nm blue and 633-nm red light in reducing inflammatory lesions in both mild, moderate and severe acne patients using a regimen of eight light treatments over 4 weeks.
Blue light: Blue light therapy (415 nm) is effective at activating coproporphyrin III and protoporphyrin IX, subsequently destroying the Propionibacterium acnes bacteria. Omnilux blue was utilized in the study to deliver a non-coherent blue light at 415 nm wavelength, 40 mW/cm2 intensity and a total dose of 48 J/cm2 after 20 minutes of exposure.
Red light: Red light (633 nm) is less effective at activating coproporphyrin III than blue light; however, it is a potent activator of protoporphyrin IX, also found in P. acnes bacteria. Because red light penetrates deeper into tissue than blue light does, it is possible that red light actively destroys P. acnes residing in the lower regions of the sebaceous gland. Another added benefit of red light is that it has anti-inflammatory properties. In this study, Omnilux revive was used to deliver non-coherent red light at a 633-nm wavelength, 80 mW/cm2 at a total dose of 96 J/cm2 after 20-minute exposure.
Treatment
In the study, 24 participants with mild to severe acne underwent eight sessions of treatment — two sessions per week 3 days apart, alternating between 415-nm blue light (20 minutes/session, 48 J/cm2) and 633-nm red light (20 minutes/session, 96 J/cm2). Each study participant also received a gentle facial wash followed by treatment with aluminium oxide crystal microdermabrasion (5-minute treatment time per full face) before each light treatment.
Patients’ acne was assessed at baseline and at weeks 2, 4, 8 and 12. The study was unblinded and no control group was used. Study participants also assessed their outcomes, as well.
Study Results
4-week follow-up. At this point, the mean lesion count reduction was significant at 46% (p=0.001).
12-week follow-up. At this time, the mean lesion count reduction was also significant at 81% (p=0.001).
Mild acne. Comparing lesion count reduction at the
12-week follow-up between participants with mild to moderate acne and those with severe acne, those with a mild to moderate condition showed a mean reduction of 81.3% (p=0.01).
Severe acne. Study participants who had severe acne exhibited a mean reduction of 82.5% (p=0.001).
For more information regarding mean lesion count reductions, see Table 1.
Patient and dermatologist assessments were similar, and neither study participants nor investigating physicians graded the overall response as “worse” or “unchanged.” Investigator and patient assessments were comparable, with most study participants (68%) assessing the treatment as having a “marked improvement” on their acne, as compared with 59% of the physicians who participated in the study. Regarding an assessment of total clearance, at 12 weeks, 9% of participants reported total clearance and the investigating dermatologists reported this effect in 14% of subjects. For a look at how more parameters compare between study participants and investigators, see Table 2.
Two participants reported mild facial erythema, which was the only side effect noted.
Although the light therapy course achieved considerable reduction in papules, pustules and nodules, comedo counts were minimally affected. This may be an indication for the addition of an anticomedonal preparation used adjunctively with light therapy treatments for acne.
Source: Goldberg DJ, Russell BA. Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to severe acne vulgaris. Journal of Cosmetic and Laser Therapy. 2006; 8: 71–75.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.”
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Review of Studies Shows Efficacy and Tolerability in Retinoid-Containing Combination Regimens for Acne
Because combination therapy involving a retinoid — typically a retinoid paired with oral antibiotics or topical benzoyl peroxide and antibiotic products — for acne patients, an overview of studies was offered. These studies evaluated similar efficacy points and differences in tolerability, safety and patient satisfaction that may suggest that one combination treatment regimen may exhibit more preferable outcomes than another.
Therapeutic Regimens
Summaries of the different trials described the method and findings related to efficacy — particularly in regard to inflammatory and noninflammatory acne — and tolerability related to peeling, erythema, drying, burning and pruritis.
Retinoid and oral antibiotic trials included two trials:
1. a 12-week study of adapalene gel 0.1% and doxycycline combination (Figure 1A)
2. a 24-week study using tazarotene gel 0.1% and minocycline.
Retinoid and topical antimicrobial combinations were studied in three trials:
1. a 24-week study of adapalene gel 0.1% and clindamycin topical solution 1%
2. a 12-week trial with topical tretinoin 0.025%/clindamycin 1% hydrogel
3. a 6-month study evaluating adapalene gel 0.1% and BPO topical lotion 5%.
Retinoid and topical BPO/AB combination therapy was assessed in:
1. a 12-week study of tazarotene cream 1% + topical BPO/AB gel
2. the MORE Trial, a 12-week adapalene gel 0.1% + topical PBO/AB subset analysis.
“Excellent” Tolerability
In their conclusions, the authors focused on adapalene gel. They determined that the data suggest that when used in combination with a topical antibiotic or benzoyl agent,
adapalene gel 0.1% offers similar lesion count reductions to other types of retinoid medications plus it also offers “excellent tolerability.” n
Poster authors: James L. Campbell Jr., M.D., M.S., Lori A. Johnson, Ph.D.
Solubilized Benzoyl Peroxide (BP) Gel Better Tolerated and More Effective Than Either BP Alone or in Combination Formulations Tested
A newly developed 5% solubilized benzoyl peroxide (BPO) gel with high bioavailability was recently shown to offer greater bactericidal activity against Propionibacterium acnes in the follicles and on the skin surface than either a generic 5% BPO formulation or a combination 5% BPO/clindamycin product.
Noting that BPO’s bacterial activity against P. acnes and comedolytic activity, benzoyl peroxide is theoretically highly beneficial for both inflammatory and non-inflammatory acne lesions, investigators blamed its poor solubility for hindering its ability to enter the follicles and so reach areas where P. acnes proliferate.
Split-Screen Study
Its improved efficacy with improved solubility was demonstrated in a split-screen randomized study of patients aged 12 to 40 with mild to moderate acne which compared both the efficacy and tolerability of this solubilized BPO gel (plus toner) with that of a commercially available BPO/clindamycin product.
All patients applied solubilized 5% BPO gel plus toner containing 2% salicylic acid to one of their face and a commercially available BPO/clindamycin combination product to the other twice daily for 2 weeks. They were evaluated at baseline and after weeks 1 and 2 in term of inflammatory and non-inflammatory lesion count; the were also assessed for tolerability evidences such as dryness and erythema.
Better Lesion Count Reductions
The solubilized BPO regimen resulted in greater and more rapid reductions in lesion counts than the BPO/clindamycin regimen (Figure). While there were no serious adverse events, 4 of 34 patients complained of typical BPO side effects such mild burning, dryness, stinging, erythema, swelling, and itching; one reported a rash.
Poster authors: David C. Wilson, M.D., Kappa P Meadows, M.D., Jose Ramirez, Ph.D.
Is Ethnicity a Factor in Acne Patients’ Response to Therapy?
Using data compiled from the Measuring Acne Outcomes in a Real-world Experience (MORE) trial, a group of New York dermatologists gauged differences in the response of ethnic skin to different acne treatments.
Their poster, which was presented at the recent AAD meeting in Washington, D.C., underscored the special challenges involved in treating people of color with acne. Darker skin, with its clinical and histopathological differences compared with white skin, was highlighted because of its higher propensity toward post-inflammatory hyperpigmentation.
Patients and Methods
Investigators examined data compiled on 1,979 patients treated with adapalene.
These patients used a variety of adapalene 0.1% gel-containing regimens for a period of 12 weeks. Among these regimens were adapalene with benzoyl peroxide/antibiotic and adapalene with oral antibiotics among several others. Assessments were made at baseline, week 6 and week 12.
Reported findings related to ethnic skin were based on a subgroup analysis which statistically compared the following races: Asian, Hispanic, Black, American Indian/Alaskan Native Pacific Islander/other.
Similar Tolerability
While those in all racial groups demonstrated similar cutaneous tolerability to adapalene-containing combination regimens, efficacy findings did reflect notable differences.
Black and Hispanic patients showed significantly better improvement in inflammatory lesions compared to white patients.
Asian patients had higher IGA percent success at week 6 and 12 in comparison to all races.
However, overall there were no significant differences in total lesion reduction found among the different racial groups at any point in the study.
Poster authors: Fran E. Cook-Bolden, M.D., Luz E. Colon, M.S.; Sheila C. Gardner, M.S.; and Lori A. Johnson, Ph.D.
Study Finds No Benefit in Switching from One Retinoid to Another After 6 Weeks
Doctors who switch patients from one topical retinoid to another in hopes of achieving faster improvement can abandon the practice, which has been found to offer no clinical benefit in a recent study. What’s more, it may actually impair tolerability outcomes, according to a study that compared a 12-week treatment with tazarotene 0.1% cream with a 6-week treatment with adapalene 0.1% gel followed by a
6-week treatment with tazarotene 0.1% cream.
Switching Retinoids
Topical retinoids, such as adapalene and tazarotene are considered appropriate first-line therapy, either alone or in combination with antimicrobials, for all cases of acne with the exception of the most severe. Although the two agents have similar efficacy profiles, adapalene has demonstrated a more favorable tolerability profile. Some physicians have reported using a strategy in patients complaining of slow response in which they prescribe adapalene 0.1% gel for the first 6 weeks of treatment, then switch to tazarotene.
Believing that both retinoids have a slower onset of action and that the efficacy seen by patients switched would have occurred had they remained on the original prescriptions, the practice was put to the test below, which supports the hypothesis that remaining on one retinoid for 12 weeks is as effective as switching after 6 weeks.
Patients and Methods
This was a randomized, evaluator-blinded, multicenter trial to evaluate and compare the efficacy and safety of three treatment regimens: adapalene 0.1% gel daily for 12 weeks; tazarotene 0.1% cream daily for 12 weeks; and adapalene 0.1% gel daily for 6 weeks followed by tazarotene 0.1% cream daily for 6 weeks.
The study involved 302 patients, both male and female between 12 and 35 years of age, with at least 20 inflammatory lesions, between 15 and 100 non-inflammatory lesions, and not more than 3 nodulocystic lesions. Patients were not allowed to have had previous topical acne therapy within the previous 4 weeks or systemic therapy within the previous 6 months before entering the study. Patients were randomized to one of the above treatment arms and evaluations were made at baseline, week 2, week 6, week 8 and week 12.
Percent change from baseline in total lesion counts at week 12 was the primary efficacy outcome, with secondary outcomes including total lesion count changes at other time points, inflammatory and noninflammatory lesion count changes and investigator global assessment of severity.
Tolerability assessments and adverse events were recorded to evaluate the safety of the treatments. Physician and patient surveys were given to collect additional information about the attitudes and opinions related to these three treatment courses.
Evaluating the Differences
There were no significant differences among the three groups for baseline severity as determined by static global severity scoring, total lesion counts or inflammatory lesion counts. The switch group has significantly more noninflammatory lesions at baseline compared to the other two treatment groups.
Efficacy outcomes for adapalene 0.1% gel and tazarotene 0.1% cream were similar, and switching retinoids midway through the treatment did not result in enhanced outcomes.
In fact, according to these findings, the switch actually impaired the tolerability of the retinoid therapy: Tolerability evaluations suggest that switching retinoids may result in increased signs and symptoms of cutaneous irritation following the switch, with more than twice as many “definitely related” adverse events occurred with tazarotene than with adapalene.
Poster authors; Diane M. Thiboutot, M.D., Luz E. Colon, M.S., Lori A. Johnson, Ph.D., Ron W Gottschalk, M.D.
