Prescribing — or Not Prescribing — Isotretinoin in Today’s Regulatory Climate
A candid conversation between two leading dermatologists.
Dr. Del Rosso: With many acne patients who have refractory acne, at some point they are likely to need isotretinoin. There just aren’t other viable alternatives for this drug that are as consistently effective.
We’re all experiencing some of the difficulties in prescribing this drug that have resulted from the iPLEDGE pregnancy risk-management program because there are still hassles related to timing of prescribing and certain laboratory tests that must be completed in order for patients to obtain their prescriptions. However, it has become easier to navigate than it was 3 or 4 months ago as prescribers and their office staffs have become familiar with the program.
This program may have affected access to isotretinoin in a timely manner so that patients may have to continue other therapies longer. However, the criteria regarding who needs isotretinoin has not changed because of iPLEDGE.
Dr. Fried: I’ve heard of dermatologists who have stopped prescribing isotretinoin or who are prescribing it less often as a result of the difficulties resulting from the iPLEDGE program.
Dr. Del Rosso: If there are dermatologists who used to prescribe isotretinoin who are suddenly not prescribing it, they could be opening themselves up for criticism. If they’re suddenly withholding a therapy that they know is the right choice and not offering patients any other avenue for obtaining this drug, that raises some interesting issues.
Dr. Fried: It does, and some of the issues related to not using isotretinoin are already being explored by attorneys. For example, if you Google “isotretinoin”, you’ll see tons of Web sites from attorneys who are trying to attract patients who have acne scars to see whether or not they were offered isotretinoin as a treatment option. I’ve already been subpoenaed twice for cases in which dermatologists had been cited for not prescribing isotretinoin. I will never testify in cases such as these; however, this just goes to show you that the lawyers are catching on.
Dr. Del Rosso: The issue becomes very interesting, especially if it has been established that you used to prescribe isotretinoin. That’s not a hard thing to find out. Also, if you previously treated patients, they improved, and now you have the same types of patients yet you’re no longer offering isotretinoin as an option, that might potentially raise some professional or medico-legal issues.
Now, if instead you explained to the patient that he or she is a candidate for isotretinoin but that you were no longer prescribing this drug, but referred the patient to a registered isotretinoin prescriber, I still believe this is sufficient. Is this approach really any different than dermatologists who recommend to patients that they need a certain biologic for psoriasis but refer them to another doctor who routinely prescribes those types of drugs?
Dr. Fried: Except if I have someone who I send to Dr. X, but then Dr. X has a 3-month waiting period, then what? The referring dermatologists might still face problems.
Dr. Del Rosso: You can’t just decide which therapies to offer or not offer when it is clear what the patient needs.
It’s almost like the gag orders from years past that had been imposed by some insurance companies. Some of them required that if you signed up for their plan, you could only discuss with patients the therapies that were approved on their plan. Doctors would sign these contracts and then find out about these gag orders later.
Dr. Fried: Some of the present prescribing difficulties with isotretinoin might actually have a positive impact in that we might see more of the novel therapies, such as lasers and photodynamic therapy, become available for acne.
Dr. Del Rosso: I think we will, but to get the kind of clinical outcomes that are needed, we need more scientific information about exactly how to perform these therapies to achieve consistent results.
Dr. Fried: It’s true. Right now a lot is in flux regarding exact therapeutic parameters for treatment with lights, lasers and ALA/PDT, but we’re moving in the right direction with these treatments.
Dr. Del Rosso is a Clinical Assistant Professor in the Department of Dermatology at the University of Nevada School of Medicine in Las Vegas.
Dr. Fried is a dermatologist and a psychologist in private practice in Yardley, PA.
Acne and Rosacea
New society welcomes members.
The American Acne & Rosacea Society (AARS) is an idea “that has been incubating for many years,” explains AARS President-Elect Hilary Baldwin, M.D. “It was actually created to fill several voids,” she adds.
According to Dr. Baldwin, these voids include the following:
1. recognition that there needs to be a forum for the discussion of acne and rosacea that begins at the advanced level in order to exchange novel ideas and concepts.
2. improvement in the care of patients.
3. a venue for defending scientific findings with regard to acne and rosacea.
Acne and rosacea are often trivialized in the lay press and the medical community, says Dr. Baldwin. “A unified voice is necessary to assure that the concerns will be heard. This voice should be an organization of well-meaning, disease-specific experts,” she says. “As managed care increasingly constricts our practices and the noose around the isotretinoin neck tightens, the AARS will be able to step forward to provide rational and thoughtful input.”
The AARS is a conglomeration of experts in the field of acne and rosacea, and the society’s membership goal is to welcome everyone with interest in the conditions of acne and rosacea, specifically those in the trenches doing the basic and clinical research and caring for patients on a daily basis, Dr. Baldwin explains.
“Members would look forward to being the first to know about new science and innovative treatments,” says Dr. Baldwin. Furthermore, she adds, “AARS would also act as an audience upon which to audition new ideas,” she explains.
“We are looking for people who are anxious to be the defenders of the disease and our science and those who are passionate about creating a voice to defend our patients,” says Dr. Baldwin.
To find out more about the AARS, contact Dr. Baldwin at hbaldwin@downstate.edu.
Treating Truncal Acne
The relative roles for topical and systemic antibiotics.
Researchers conducted a double-blind, randomized, 10-week study to evaluate treatment with benzoyl peroxide (BPO) 9% daily, clindamycin phosphate 1% foam daily plus doxycylcine 100 mg twice daily versus BPO 9% daily plus doxycycline 100 mg twice daily without clindamycin foam for the treatment of truncal acne.
The 71 patients enrolled in the study were ≥16 years of age and had acne with truncal involvement on the back with or without chest involvement. Patients were excluded if they had a diagnosis of nodulocycstic acne vulgaris, had concurrent intake or use within 4 weeks of baseline of systemic anti-inflammatory medication, concurrent application or use within 2 weeks of baseline of topical anti-inflammatory medication, history of sensitivity or intolerance associated with use of components of medications or products used
in this study, or presence of concurrent medical condition, which the investigators believed to interfere with study outcomes of patient assessments.
There was a washout period of at least 2 weeks for all previous topical acne therapies, at least 4 weeks for systemic antibiotic therapy and more than 6 months for oral isotretinoin.
Patients were enrolled into one of the two groups and evaluated at baseline and weeks 2, 6 and 10 (+/- 5-day window). The primary efficacy assessments were lesion count reduction, investigator global assessment (IGA) and patient tolerability assessment.
Results
A total of 60 patients completed the study (32 in the group treated with clindamycin and 28 in the group not treated with clindamycin). Five patients didn’t complete the study due to difficulty keeping appointments and six patients discontinued treatment with doxycycline within the first 2 weeks of the study due to gastrointestinal upset.
The group treated with clindamycin phosphate foam 1% and BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 1) saw greater mean inflammatory and total lesion count reductions than the group treated with BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 2) at weeks 6 and 10. Inflammatory lesion count reductions at weeks 6 and 10 were 69.2% and 88.4%, respectively, in Group 1 compared to 50% and 70.8%, respectively, in Group 2. The total lesion count reductions at weeks 6 and 10 were 63.8% and 86.1%, respectively, in Group 1 compared to 45.7% and 64.2%, respectively, in Group 2.
Based on IGA at week 10, 70% of the patients in Group 1 were at least “near clear” vs. 45% in Group 2. The topical combination of clindamycin phosphate foam 1% and benzoyl peroxide 9% cleanser once daily plus doxycycline 100 mg twice daily was well tolerated based on patient assessments.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Joseph Bikowski, M.D., Neal Bhatia, M.D., and Steve Hawkes, PA-C.
Recommendations for Antibiotic Use
Scientific panel reports on its preliminary consensus statement.
The Scientific Panel on Antibiotic Use in Dermatology (SPAUD), which includes a mix of dermatologists and infectious disease specialists, unveiled its preliminary consensus statement regarding the use of antibiotics in dermatology at the summer American Academy of Dermatology meeting in San Diego in late July.
In late April of this year, the panel, which includes members James Q. Del Rosso, D.O., who chaired the meeting, Dirk M. Elston, M.D., Jan Hirschmann, M.D., James Leyden, M.D., Theodore Rosen, M.D., Kenneth Tomecki, M.D., and Guy Webster, M.D., Ph.D., met to fulfill a number of goals. These included the following:
• Develop a consensus on the use of antibiotics with regard to treating inflammatory disorders in dermatology, such as acne and rosacea.
• Determine whether dermatologists should modify antibiotic prescribing patterns for both systemic and topical antibiotics.
• Discuss issues related to antibiotic resistance in treating skin diseases. (See Figure 1 for specific information related to this issue.)
• Review the impact of community-acquired methicillin-resistant Staphylococcus aureus.
• Define the anti-inflammatory and non anti-inflammatory effects of antibiotics that might be clinically relevant.
• Define situations in which antibiotics may not be necessary.
After discussing numerous issues relating to antibiotic use, the panel developed a preliminary consensus statement that reported on using antibiotics for acne and rosacea, skin and soft tissue infections as well as pre-operative prophylactic antibiotic therapy.
With regard to the recommendations for acne and rosacea, SPAUD stated the following:
• Antibiotic monotherapy, especially prolonged use, is not recommended in the treatment of acne vulgaris. Prolonged topical or oral antibiotic therapy for acne vulgaris is best accompanied by use of benzoyl peroxide to optimize efficacy and mitigate emergence of less sensitive Propionibacterium acnes strains.
• Combination use of benzoyl peroxide, a topical and/or oral antibiotic and a topical retinoid for acne is rational with the latter being applicable for long-term maintenance treatment once adequate disease control is achieved. If antibiotics are used chronically to sustain long-term maintenance of therapeutic response, concomitant use of benzoyl peroxide is recommended to limit emergence of antibiotic resistance (for example, P. acnes). Whenever possible, the duration of chronic oral antibiotic therapy for acne or rosacea should be limited as much as is clinically feasible.
• Oral antibiotics have characteristically been used over the last 4 to 5 decades for rosacea; however, efficacy of oral agents such as tetracycline is probably related to anti-inflammatory effects more so than antibiotic activity in this disorder. Anti-inflammatory effects of oral tetracyclines, especially doxycycline and minocycline, are also believed to contribute to improvement of acne.
• Progressive concerns regarding emergence of P. acnes, commensal organisms, and potentially pathogenic bacteria in patients undergoing chronic antibiotic therapy, especially with an oral agent, warrants further study regarding issues related to antibiotics commonly prescribed by dermatologists, especially for chronic use.
• Although topical and oral antibiotic therapy may impact the microbiologic activity of skin and nares, data are more limited with topical antibiotic use, especially with regard to clinical significance. Further study is needed in this area to better differentiate implications that may be clinically significant to both individual patients and the general population.
• Presence of less sensitive P. acnes organisms contribute to decreased efficacy of antibiotic treatment in some patients, especially if a high density of less sensitive strains are present. However, oral antibiotics such as doxycycline and minocycline, and topical clindamycin, have continued to maintain efficacy in many patients, especially when used in appropriate combination with other agents (for example, benzoyl peroxide and topical retinoids).
Comparing Moisturization Potential
A comparison of two acne gels.
A two-part study was designed to compare the moisturization potential of two acne gels, both of which contain 5% benzoyl peroxide and 1% clindamycin. One of the acne gels contains dimethicone and glycerin.
In the first study, which was a 4-hour moisturization study, each volar forearm had one site that was treated with one of the acne gels (one gel on the left forearm and the other gel on the right forearm) and one site serving as an untreated control. Electrical conductance measurements were taken at baseline and 4 hours after treatment to measure skin surface hydration.
In the second study, which was an 8-day moisturization study, baseline electrical conductance measurements and water loss measurements were take at two volar forearm sites (one on each arm) and the sites were assessed for dryness and erythema by an expert grader. Each site was then treated with one of the acne gels for 8 days and conductance water loss measurements and dryness and erythema assessments were performed on day 8 before treatment and 4 hours post-treatment.
Results
For the 4-hour study, 31 females were enrolled and completed the study. Skin surfaced hydration, as measured by electrical conductance, was significantly (p<0.00001) reduced from baseline levels 4 hours post-treatment with both gels. Skin treated with the gel containing glycerin/dimethicone was significantly (p<0.00001) more hydrated, as measured by net chance from baseline
in electrical conductance, at 4 hours post-treatment as compared to the skin treated with the gel without glycerin/dimethicone.
In the 8-day study, 28 females were enrolled and 23 completed the study. The was no significant difference between treatments, according to the expert grader’s assessment of dryness and erythema on day 8. There was no significant decrease in skin surface hydration, measured by electrical conductance, after 8 days of treatment with the gel containing glycerin/dimethicone while treatment with the gel without glycerin/dimethicone resulted in significant (p<0.05) decrease in skin surface hydration. Treatment with the gel containing glycerin/dimethicone resulted in significantly (p<0.05) lower mean water loss value at day 8 (before treatment) compared to baseline.
Poster Authors: Charles Zerweck, Ph.D., Gary L. Grove, Ph.D., and Joanne M. Fraser, Ph.D.
Oracea Approved to Treat Rosacea
An alternative to systemic antibiotics.
CollaGenex Pharmaceuticals recently launched its 40-mg, slow-release doxycycline (Oracea), which was just FDA-approved as the first orally administered, systemically delivered drug for the treatment of the inflammatory lesions of rosacea in adult patients.
Oracea is the first alternative to systemic antibiotics. According to CollaGenex, the unique formulation of 40-mg doxycycline maintains the blood plasma concentration of the drug below the threshold for antimicrobial effect. This dose is anti-inflammatory without antibiotic activity, so there are no potential issues regarding emergence of antibiotic resistance, especially with long-term administration. A lack of antimicrobial activity has been confirmed based on pharmacokinetic data and microbiologic studies completed over durations of up to 18 months. The side effects were similar to placebo. Also, photosensitivity and vaginal candidiasis were not seen in clinical trials, further supporting the lack of antimicrobial activity.
Clinical Trials
In two double-blinded, placebo-controlled Phase III clinical studies, patients were administered either Oracea or placebo once a day for 16 weeks. For the study, 537 patients were enrolled in 28 centers across the United States. Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo group.
In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients received placebo. The differences were clinically and statistically highly significant (p<0.001) in each study.
A separate clinical trial of 266 patients, evaluated the safety of Oracea over a 9-month period. This study demonstrated that the side effects of Oracea were comparable to placebo over a longer period of time. Safety beyond 9 months has not yet been established.
Tretinoin Microsphere Gel 0.04% with Clindamycin Phosphate 1% Foam
Evaluating the benefit of combination therapy.
An investigator-blinded, randomized, 10-week trial was conducted to evaluate the comparative efficacy of once-daily tretinoin microsphere gel 0.04% and clindamycin phosphate 1% foam used concomitantly versus once-daily clindamycin phosphate 1% foam monotherapy for the treatment of moderate truncal acne vulgaris in adult patients. The tolerability of the combination therapy in comparison to monotherapy was also assessed. Patients had to be 16 years of age or older with acne vulgaris of the back, with or without chest involvement. Patients had 10 to 25 superficial inflammatory lesions and two or fewer nodules and 10 or more non-inflammatory lesions.
Patients were excluded if they used topical therapy within 2 weeks of the start of the study, systemic antibiotic therapy within 4 weeks of the study start or oral isotretinoin within 6 months of the study. Patients were also excluded if they had a history of sensitivity or intolerance to medications or products used in the study or any medical condition with the potential to interfere with the study.
Eligible patients were randomized into two groups:
• Group A: Clindamycin 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening.
• Group B: Clindamycin 1% foam once daily in the
morning.
Patients were assessed at baseline and weeks 2, 6 and 10 (+/- 5-day window) for efficacy and skin tolerability.
Results
The mean reductions from baseline in inflammatory lesion count at weeks 6 and 10 were 63.6% and 72.7%, respectively, for Group A compared to 53.3% and 57.1%, respectively, for Group B.
The mean reductions from baseline in non-inflammatory lesion count at weeks 6 and 10 were 64.2% and 85.7%, respectively, for Group A compared to 43.7% and 56.2%, respectively, for Group B.
Investigator global assessment scores at week 10 varied from moderately clear to nearly clear in both groups.
The combination therapy of clindamycin phosphate 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening produced a greater mean reduction in inflammatory and non-inflammatory truncal acne lesions than clindamycin phosphate 1% foam used as monotherapy. The combination therapy was well tolerated.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Neal Bhatia, M.D., Steve Hawkes, PA-C, and Lisa Sanglay, R.N.
Prescribing — or Not Prescribing — Isotretinoin in Today’s Regulatory Climate
A candid conversation between two leading dermatologists.
Dr. Del Rosso: With many acne patients who have refractory acne, at some point they are likely to need isotretinoin. There just aren’t other viable alternatives for this drug that are as consistently effective.
We’re all experiencing some of the difficulties in prescribing this drug that have resulted from the iPLEDGE pregnancy risk-management program because there are still hassles related to timing of prescribing and certain laboratory tests that must be completed in order for patients to obtain their prescriptions. However, it has become easier to navigate than it was 3 or 4 months ago as prescribers and their office staffs have become familiar with the program.
This program may have affected access to isotretinoin in a timely manner so that patients may have to continue other therapies longer. However, the criteria regarding who needs isotretinoin has not changed because of iPLEDGE.
Dr. Fried: I’ve heard of dermatologists who have stopped prescribing isotretinoin or who are prescribing it less often as a result of the difficulties resulting from the iPLEDGE program.
Dr. Del Rosso: If there are dermatologists who used to prescribe isotretinoin who are suddenly not prescribing it, they could be opening themselves up for criticism. If they’re suddenly withholding a therapy that they know is the right choice and not offering patients any other avenue for obtaining this drug, that raises some interesting issues.
Dr. Fried: It does, and some of the issues related to not using isotretinoin are already being explored by attorneys. For example, if you Google “isotretinoin”, you’ll see tons of Web sites from attorneys who are trying to attract patients who have acne scars to see whether or not they were offered isotretinoin as a treatment option. I’ve already been subpoenaed twice for cases in which dermatologists had been cited for not prescribing isotretinoin. I will never testify in cases such as these; however, this just goes to show you that the lawyers are catching on.
Dr. Del Rosso: The issue becomes very interesting, especially if it has been established that you used to prescribe isotretinoin. That’s not a hard thing to find out. Also, if you previously treated patients, they improved, and now you have the same types of patients yet you’re no longer offering isotretinoin as an option, that might potentially raise some professional or medico-legal issues.
Now, if instead you explained to the patient that he or she is a candidate for isotretinoin but that you were no longer prescribing this drug, but referred the patient to a registered isotretinoin prescriber, I still believe this is sufficient. Is this approach really any different than dermatologists who recommend to patients that they need a certain biologic for psoriasis but refer them to another doctor who routinely prescribes those types of drugs?
Dr. Fried: Except if I have someone who I send to Dr. X, but then Dr. X has a 3-month waiting period, then what? The referring dermatologists might still face problems.
Dr. Del Rosso: You can’t just decide which therapies to offer or not offer when it is clear what the patient needs.
It’s almost like the gag orders from years past that had been imposed by some insurance companies. Some of them required that if you signed up for their plan, you could only discuss with patients the therapies that were approved on their plan. Doctors would sign these contracts and then find out about these gag orders later.
Dr. Fried: Some of the present prescribing difficulties with isotretinoin might actually have a positive impact in that we might see more of the novel therapies, such as lasers and photodynamic therapy, become available for acne.
Dr. Del Rosso: I think we will, but to get the kind of clinical outcomes that are needed, we need more scientific information about exactly how to perform these therapies to achieve consistent results.
Dr. Fried: It’s true. Right now a lot is in flux regarding exact therapeutic parameters for treatment with lights, lasers and ALA/PDT, but we’re moving in the right direction with these treatments.
Dr. Del Rosso is a Clinical Assistant Professor in the Department of Dermatology at the University of Nevada School of Medicine in Las Vegas.
Dr. Fried is a dermatologist and a psychologist in private practice in Yardley, PA.
Acne and Rosacea
New society welcomes members.
The American Acne & Rosacea Society (AARS) is an idea “that has been incubating for many years,” explains AARS President-Elect Hilary Baldwin, M.D. “It was actually created to fill several voids,” she adds.
According to Dr. Baldwin, these voids include the following:
1. recognition that there needs to be a forum for the discussion of acne and rosacea that begins at the advanced level in order to exchange novel ideas and concepts.
2. improvement in the care of patients.
3. a venue for defending scientific findings with regard to acne and rosacea.
Acne and rosacea are often trivialized in the lay press and the medical community, says Dr. Baldwin. “A unified voice is necessary to assure that the concerns will be heard. This voice should be an organization of well-meaning, disease-specific experts,” she says. “As managed care increasingly constricts our practices and the noose around the isotretinoin neck tightens, the AARS will be able to step forward to provide rational and thoughtful input.”
The AARS is a conglomeration of experts in the field of acne and rosacea, and the society’s membership goal is to welcome everyone with interest in the conditions of acne and rosacea, specifically those in the trenches doing the basic and clinical research and caring for patients on a daily basis, Dr. Baldwin explains.
“Members would look forward to being the first to know about new science and innovative treatments,” says Dr. Baldwin. Furthermore, she adds, “AARS would also act as an audience upon which to audition new ideas,” she explains.
“We are looking for people who are anxious to be the defenders of the disease and our science and those who are passionate about creating a voice to defend our patients,” says Dr. Baldwin.
To find out more about the AARS, contact Dr. Baldwin at hbaldwin@downstate.edu.
Treating Truncal Acne
The relative roles for topical and systemic antibiotics.
Researchers conducted a double-blind, randomized, 10-week study to evaluate treatment with benzoyl peroxide (BPO) 9% daily, clindamycin phosphate 1% foam daily plus doxycylcine 100 mg twice daily versus BPO 9% daily plus doxycycline 100 mg twice daily without clindamycin foam for the treatment of truncal acne.
The 71 patients enrolled in the study were ≥16 years of age and had acne with truncal involvement on the back with or without chest involvement. Patients were excluded if they had a diagnosis of nodulocycstic acne vulgaris, had concurrent intake or use within 4 weeks of baseline of systemic anti-inflammatory medication, concurrent application or use within 2 weeks of baseline of topical anti-inflammatory medication, history of sensitivity or intolerance associated with use of components of medications or products used
in this study, or presence of concurrent medical condition, which the investigators believed to interfere with study outcomes of patient assessments.
There was a washout period of at least 2 weeks for all previous topical acne therapies, at least 4 weeks for systemic antibiotic therapy and more than 6 months for oral isotretinoin.
Patients were enrolled into one of the two groups and evaluated at baseline and weeks 2, 6 and 10 (+/- 5-day window). The primary efficacy assessments were lesion count reduction, investigator global assessment (IGA) and patient tolerability assessment.
Results
A total of 60 patients completed the study (32 in the group treated with clindamycin and 28 in the group not treated with clindamycin). Five patients didn’t complete the study due to difficulty keeping appointments and six patients discontinued treatment with doxycycline within the first 2 weeks of the study due to gastrointestinal upset.
The group treated with clindamycin phosphate foam 1% and BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 1) saw greater mean inflammatory and total lesion count reductions than the group treated with BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 2) at weeks 6 and 10. Inflammatory lesion count reductions at weeks 6 and 10 were 69.2% and 88.4%, respectively, in Group 1 compared to 50% and 70.8%, respectively, in Group 2. The total lesion count reductions at weeks 6 and 10 were 63.8% and 86.1%, respectively, in Group 1 compared to 45.7% and 64.2%, respectively, in Group 2.
Based on IGA at week 10, 70% of the patients in Group 1 were at least “near clear” vs. 45% in Group 2. The topical combination of clindamycin phosphate foam 1% and benzoyl peroxide 9% cleanser once daily plus doxycycline 100 mg twice daily was well tolerated based on patient assessments.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Joseph Bikowski, M.D., Neal Bhatia, M.D., and Steve Hawkes, PA-C.
Recommendations for Antibiotic Use
Scientific panel reports on its preliminary consensus statement.
The Scientific Panel on Antibiotic Use in Dermatology (SPAUD), which includes a mix of dermatologists and infectious disease specialists, unveiled its preliminary consensus statement regarding the use of antibiotics in dermatology at the summer American Academy of Dermatology meeting in San Diego in late July.
In late April of this year, the panel, which includes members James Q. Del Rosso, D.O., who chaired the meeting, Dirk M. Elston, M.D., Jan Hirschmann, M.D., James Leyden, M.D., Theodore Rosen, M.D., Kenneth Tomecki, M.D., and Guy Webster, M.D., Ph.D., met to fulfill a number of goals. These included the following:
• Develop a consensus on the use of antibiotics with regard to treating inflammatory disorders in dermatology, such as acne and rosacea.
• Determine whether dermatologists should modify antibiotic prescribing patterns for both systemic and topical antibiotics.
• Discuss issues related to antibiotic resistance in treating skin diseases. (See Figure 1 for specific information related to this issue.)
• Review the impact of community-acquired methicillin-resistant Staphylococcus aureus.
• Define the anti-inflammatory and non anti-inflammatory effects of antibiotics that might be clinically relevant.
• Define situations in which antibiotics may not be necessary.
After discussing numerous issues relating to antibiotic use, the panel developed a preliminary consensus statement that reported on using antibiotics for acne and rosacea, skin and soft tissue infections as well as pre-operative prophylactic antibiotic therapy.
With regard to the recommendations for acne and rosacea, SPAUD stated the following:
• Antibiotic monotherapy, especially prolonged use, is not recommended in the treatment of acne vulgaris. Prolonged topical or oral antibiotic therapy for acne vulgaris is best accompanied by use of benzoyl peroxide to optimize efficacy and mitigate emergence of less sensitive Propionibacterium acnes strains.
• Combination use of benzoyl peroxide, a topical and/or oral antibiotic and a topical retinoid for acne is rational with the latter being applicable for long-term maintenance treatment once adequate disease control is achieved. If antibiotics are used chronically to sustain long-term maintenance of therapeutic response, concomitant use of benzoyl peroxide is recommended to limit emergence of antibiotic resistance (for example, P. acnes). Whenever possible, the duration of chronic oral antibiotic therapy for acne or rosacea should be limited as much as is clinically feasible.
• Oral antibiotics have characteristically been used over the last 4 to 5 decades for rosacea; however, efficacy of oral agents such as tetracycline is probably related to anti-inflammatory effects more so than antibiotic activity in this disorder. Anti-inflammatory effects of oral tetracyclines, especially doxycycline and minocycline, are also believed to contribute to improvement of acne.
• Progressive concerns regarding emergence of P. acnes, commensal organisms, and potentially pathogenic bacteria in patients undergoing chronic antibiotic therapy, especially with an oral agent, warrants further study regarding issues related to antibiotics commonly prescribed by dermatologists, especially for chronic use.
• Although topical and oral antibiotic therapy may impact the microbiologic activity of skin and nares, data are more limited with topical antibiotic use, especially with regard to clinical significance. Further study is needed in this area to better differentiate implications that may be clinically significant to both individual patients and the general population.
• Presence of less sensitive P. acnes organisms contribute to decreased efficacy of antibiotic treatment in some patients, especially if a high density of less sensitive strains are present. However, oral antibiotics such as doxycycline and minocycline, and topical clindamycin, have continued to maintain efficacy in many patients, especially when used in appropriate combination with other agents (for example, benzoyl peroxide and topical retinoids).
Comparing Moisturization Potential
A comparison of two acne gels.
A two-part study was designed to compare the moisturization potential of two acne gels, both of which contain 5% benzoyl peroxide and 1% clindamycin. One of the acne gels contains dimethicone and glycerin.
In the first study, which was a 4-hour moisturization study, each volar forearm had one site that was treated with one of the acne gels (one gel on the left forearm and the other gel on the right forearm) and one site serving as an untreated control. Electrical conductance measurements were taken at baseline and 4 hours after treatment to measure skin surface hydration.
In the second study, which was an 8-day moisturization study, baseline electrical conductance measurements and water loss measurements were take at two volar forearm sites (one on each arm) and the sites were assessed for dryness and erythema by an expert grader. Each site was then treated with one of the acne gels for 8 days and conductance water loss measurements and dryness and erythema assessments were performed on day 8 before treatment and 4 hours post-treatment.
Results
For the 4-hour study, 31 females were enrolled and completed the study. Skin surfaced hydration, as measured by electrical conductance, was significantly (p<0.00001) reduced from baseline levels 4 hours post-treatment with both gels. Skin treated with the gel containing glycerin/dimethicone was significantly (p<0.00001) more hydrated, as measured by net chance from baseline
in electrical conductance, at 4 hours post-treatment as compared to the skin treated with the gel without glycerin/dimethicone.
In the 8-day study, 28 females were enrolled and 23 completed the study. The was no significant difference between treatments, according to the expert grader’s assessment of dryness and erythema on day 8. There was no significant decrease in skin surface hydration, measured by electrical conductance, after 8 days of treatment with the gel containing glycerin/dimethicone while treatment with the gel without glycerin/dimethicone resulted in significant (p<0.05) decrease in skin surface hydration. Treatment with the gel containing glycerin/dimethicone resulted in significantly (p<0.05) lower mean water loss value at day 8 (before treatment) compared to baseline.
Poster Authors: Charles Zerweck, Ph.D., Gary L. Grove, Ph.D., and Joanne M. Fraser, Ph.D.
Oracea Approved to Treat Rosacea
An alternative to systemic antibiotics.
CollaGenex Pharmaceuticals recently launched its 40-mg, slow-release doxycycline (Oracea), which was just FDA-approved as the first orally administered, systemically delivered drug for the treatment of the inflammatory lesions of rosacea in adult patients.
Oracea is the first alternative to systemic antibiotics. According to CollaGenex, the unique formulation of 40-mg doxycycline maintains the blood plasma concentration of the drug below the threshold for antimicrobial effect. This dose is anti-inflammatory without antibiotic activity, so there are no potential issues regarding emergence of antibiotic resistance, especially with long-term administration. A lack of antimicrobial activity has been confirmed based on pharmacokinetic data and microbiologic studies completed over durations of up to 18 months. The side effects were similar to placebo. Also, photosensitivity and vaginal candidiasis were not seen in clinical trials, further supporting the lack of antimicrobial activity.
Clinical Trials
In two double-blinded, placebo-controlled Phase III clinical studies, patients were administered either Oracea or placebo once a day for 16 weeks. For the study, 537 patients were enrolled in 28 centers across the United States. Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo group.
In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients received placebo. The differences were clinically and statistically highly significant (p<0.001) in each study.
A separate clinical trial of 266 patients, evaluated the safety of Oracea over a 9-month period. This study demonstrated that the side effects of Oracea were comparable to placebo over a longer period of time. Safety beyond 9 months has not yet been established.
Tretinoin Microsphere Gel 0.04% with Clindamycin Phosphate 1% Foam
Evaluating the benefit of combination therapy.
An investigator-blinded, randomized, 10-week trial was conducted to evaluate the comparative efficacy of once-daily tretinoin microsphere gel 0.04% and clindamycin phosphate 1% foam used concomitantly versus once-daily clindamycin phosphate 1% foam monotherapy for the treatment of moderate truncal acne vulgaris in adult patients. The tolerability of the combination therapy in comparison to monotherapy was also assessed. Patients had to be 16 years of age or older with acne vulgaris of the back, with or without chest involvement. Patients had 10 to 25 superficial inflammatory lesions and two or fewer nodules and 10 or more non-inflammatory lesions.
Patients were excluded if they used topical therapy within 2 weeks of the start of the study, systemic antibiotic therapy within 4 weeks of the study start or oral isotretinoin within 6 months of the study. Patients were also excluded if they had a history of sensitivity or intolerance to medications or products used in the study or any medical condition with the potential to interfere with the study.
Eligible patients were randomized into two groups:
• Group A: Clindamycin 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening.
• Group B: Clindamycin 1% foam once daily in the
morning.
Patients were assessed at baseline and weeks 2, 6 and 10 (+/- 5-day window) for efficacy and skin tolerability.
Results
The mean reductions from baseline in inflammatory lesion count at weeks 6 and 10 were 63.6% and 72.7%, respectively, for Group A compared to 53.3% and 57.1%, respectively, for Group B.
The mean reductions from baseline in non-inflammatory lesion count at weeks 6 and 10 were 64.2% and 85.7%, respectively, for Group A compared to 43.7% and 56.2%, respectively, for Group B.
Investigator global assessment scores at week 10 varied from moderately clear to nearly clear in both groups.
The combination therapy of clindamycin phosphate 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening produced a greater mean reduction in inflammatory and non-inflammatory truncal acne lesions than clindamycin phosphate 1% foam used as monotherapy. The combination therapy was well tolerated.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Neal Bhatia, M.D., Steve Hawkes, PA-C, and Lisa Sanglay, R.N.
Prescribing — or Not Prescribing — Isotretinoin in Today’s Regulatory Climate
A candid conversation between two leading dermatologists.
Dr. Del Rosso: With many acne patients who have refractory acne, at some point they are likely to need isotretinoin. There just aren’t other viable alternatives for this drug that are as consistently effective.
We’re all experiencing some of the difficulties in prescribing this drug that have resulted from the iPLEDGE pregnancy risk-management program because there are still hassles related to timing of prescribing and certain laboratory tests that must be completed in order for patients to obtain their prescriptions. However, it has become easier to navigate than it was 3 or 4 months ago as prescribers and their office staffs have become familiar with the program.
This program may have affected access to isotretinoin in a timely manner so that patients may have to continue other therapies longer. However, the criteria regarding who needs isotretinoin has not changed because of iPLEDGE.
Dr. Fried: I’ve heard of dermatologists who have stopped prescribing isotretinoin or who are prescribing it less often as a result of the difficulties resulting from the iPLEDGE program.
Dr. Del Rosso: If there are dermatologists who used to prescribe isotretinoin who are suddenly not prescribing it, they could be opening themselves up for criticism. If they’re suddenly withholding a therapy that they know is the right choice and not offering patients any other avenue for obtaining this drug, that raises some interesting issues.
Dr. Fried: It does, and some of the issues related to not using isotretinoin are already being explored by attorneys. For example, if you Google “isotretinoin”, you’ll see tons of Web sites from attorneys who are trying to attract patients who have acne scars to see whether or not they were offered isotretinoin as a treatment option. I’ve already been subpoenaed twice for cases in which dermatologists had been cited for not prescribing isotretinoin. I will never testify in cases such as these; however, this just goes to show you that the lawyers are catching on.
Dr. Del Rosso: The issue becomes very interesting, especially if it has been established that you used to prescribe isotretinoin. That’s not a hard thing to find out. Also, if you previously treated patients, they improved, and now you have the same types of patients yet you’re no longer offering isotretinoin as an option, that might potentially raise some professional or medico-legal issues.
Now, if instead you explained to the patient that he or she is a candidate for isotretinoin but that you were no longer prescribing this drug, but referred the patient to a registered isotretinoin prescriber, I still believe this is sufficient. Is this approach really any different than dermatologists who recommend to patients that they need a certain biologic for psoriasis but refer them to another doctor who routinely prescribes those types of drugs?
Dr. Fried: Except if I have someone who I send to Dr. X, but then Dr. X has a 3-month waiting period, then what? The referring dermatologists might still face problems.
Dr. Del Rosso: You can’t just decide which therapies to offer or not offer when it is clear what the patient needs.
It’s almost like the gag orders from years past that had been imposed by some insurance companies. Some of them required that if you signed up for their plan, you could only discuss with patients the therapies that were approved on their plan. Doctors would sign these contracts and then find out about these gag orders later.
Dr. Fried: Some of the present prescribing difficulties with isotretinoin might actually have a positive impact in that we might see more of the novel therapies, such as lasers and photodynamic therapy, become available for acne.
Dr. Del Rosso: I think we will, but to get the kind of clinical outcomes that are needed, we need more scientific information about exactly how to perform these therapies to achieve consistent results.
Dr. Fried: It’s true. Right now a lot is in flux regarding exact therapeutic parameters for treatment with lights, lasers and ALA/PDT, but we’re moving in the right direction with these treatments.
Dr. Del Rosso is a Clinical Assistant Professor in the Department of Dermatology at the University of Nevada School of Medicine in Las Vegas.
Dr. Fried is a dermatologist and a psychologist in private practice in Yardley, PA.
Acne and Rosacea
New society welcomes members.
The American Acne & Rosacea Society (AARS) is an idea “that has been incubating for many years,” explains AARS President-Elect Hilary Baldwin, M.D. “It was actually created to fill several voids,” she adds.
According to Dr. Baldwin, these voids include the following:
1. recognition that there needs to be a forum for the discussion of acne and rosacea that begins at the advanced level in order to exchange novel ideas and concepts.
2. improvement in the care of patients.
3. a venue for defending scientific findings with regard to acne and rosacea.
Acne and rosacea are often trivialized in the lay press and the medical community, says Dr. Baldwin. “A unified voice is necessary to assure that the concerns will be heard. This voice should be an organization of well-meaning, disease-specific experts,” she says. “As managed care increasingly constricts our practices and the noose around the isotretinoin neck tightens, the AARS will be able to step forward to provide rational and thoughtful input.”
The AARS is a conglomeration of experts in the field of acne and rosacea, and the society’s membership goal is to welcome everyone with interest in the conditions of acne and rosacea, specifically those in the trenches doing the basic and clinical research and caring for patients on a daily basis, Dr. Baldwin explains.
“Members would look forward to being the first to know about new science and innovative treatments,” says Dr. Baldwin. Furthermore, she adds, “AARS would also act as an audience upon which to audition new ideas,” she explains.
“We are looking for people who are anxious to be the defenders of the disease and our science and those who are passionate about creating a voice to defend our patients,” says Dr. Baldwin.
To find out more about the AARS, contact Dr. Baldwin at hbaldwin@downstate.edu.
Treating Truncal Acne
The relative roles for topical and systemic antibiotics.
Researchers conducted a double-blind, randomized, 10-week study to evaluate treatment with benzoyl peroxide (BPO) 9% daily, clindamycin phosphate 1% foam daily plus doxycylcine 100 mg twice daily versus BPO 9% daily plus doxycycline 100 mg twice daily without clindamycin foam for the treatment of truncal acne.
The 71 patients enrolled in the study were ≥16 years of age and had acne with truncal involvement on the back with or without chest involvement. Patients were excluded if they had a diagnosis of nodulocycstic acne vulgaris, had concurrent intake or use within 4 weeks of baseline of systemic anti-inflammatory medication, concurrent application or use within 2 weeks of baseline of topical anti-inflammatory medication, history of sensitivity or intolerance associated with use of components of medications or products used
in this study, or presence of concurrent medical condition, which the investigators believed to interfere with study outcomes of patient assessments.
There was a washout period of at least 2 weeks for all previous topical acne therapies, at least 4 weeks for systemic antibiotic therapy and more than 6 months for oral isotretinoin.
Patients were enrolled into one of the two groups and evaluated at baseline and weeks 2, 6 and 10 (+/- 5-day window). The primary efficacy assessments were lesion count reduction, investigator global assessment (IGA) and patient tolerability assessment.
Results
A total of 60 patients completed the study (32 in the group treated with clindamycin and 28 in the group not treated with clindamycin). Five patients didn’t complete the study due to difficulty keeping appointments and six patients discontinued treatment with doxycycline within the first 2 weeks of the study due to gastrointestinal upset.
The group treated with clindamycin phosphate foam 1% and BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 1) saw greater mean inflammatory and total lesion count reductions than the group treated with BPO 9% cleanser once daily plus doxycycline 100 mg twice daily (Group 2) at weeks 6 and 10. Inflammatory lesion count reductions at weeks 6 and 10 were 69.2% and 88.4%, respectively, in Group 1 compared to 50% and 70.8%, respectively, in Group 2. The total lesion count reductions at weeks 6 and 10 were 63.8% and 86.1%, respectively, in Group 1 compared to 45.7% and 64.2%, respectively, in Group 2.
Based on IGA at week 10, 70% of the patients in Group 1 were at least “near clear” vs. 45% in Group 2. The topical combination of clindamycin phosphate foam 1% and benzoyl peroxide 9% cleanser once daily plus doxycycline 100 mg twice daily was well tolerated based on patient assessments.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Joseph Bikowski, M.D., Neal Bhatia, M.D., and Steve Hawkes, PA-C.
Recommendations for Antibiotic Use
Scientific panel reports on its preliminary consensus statement.
The Scientific Panel on Antibiotic Use in Dermatology (SPAUD), which includes a mix of dermatologists and infectious disease specialists, unveiled its preliminary consensus statement regarding the use of antibiotics in dermatology at the summer American Academy of Dermatology meeting in San Diego in late July.
In late April of this year, the panel, which includes members James Q. Del Rosso, D.O., who chaired the meeting, Dirk M. Elston, M.D., Jan Hirschmann, M.D., James Leyden, M.D., Theodore Rosen, M.D., Kenneth Tomecki, M.D., and Guy Webster, M.D., Ph.D., met to fulfill a number of goals. These included the following:
• Develop a consensus on the use of antibiotics with regard to treating inflammatory disorders in dermatology, such as acne and rosacea.
• Determine whether dermatologists should modify antibiotic prescribing patterns for both systemic and topical antibiotics.
• Discuss issues related to antibiotic resistance in treating skin diseases. (See Figure 1 for specific information related to this issue.)
• Review the impact of community-acquired methicillin-resistant Staphylococcus aureus.
• Define the anti-inflammatory and non anti-inflammatory effects of antibiotics that might be clinically relevant.
• Define situations in which antibiotics may not be necessary.
After discussing numerous issues relating to antibiotic use, the panel developed a preliminary consensus statement that reported on using antibiotics for acne and rosacea, skin and soft tissue infections as well as pre-operative prophylactic antibiotic therapy.
With regard to the recommendations for acne and rosacea, SPAUD stated the following:
• Antibiotic monotherapy, especially prolonged use, is not recommended in the treatment of acne vulgaris. Prolonged topical or oral antibiotic therapy for acne vulgaris is best accompanied by use of benzoyl peroxide to optimize efficacy and mitigate emergence of less sensitive Propionibacterium acnes strains.
• Combination use of benzoyl peroxide, a topical and/or oral antibiotic and a topical retinoid for acne is rational with the latter being applicable for long-term maintenance treatment once adequate disease control is achieved. If antibiotics are used chronically to sustain long-term maintenance of therapeutic response, concomitant use of benzoyl peroxide is recommended to limit emergence of antibiotic resistance (for example, P. acnes). Whenever possible, the duration of chronic oral antibiotic therapy for acne or rosacea should be limited as much as is clinically feasible.
• Oral antibiotics have characteristically been used over the last 4 to 5 decades for rosacea; however, efficacy of oral agents such as tetracycline is probably related to anti-inflammatory effects more so than antibiotic activity in this disorder. Anti-inflammatory effects of oral tetracyclines, especially doxycycline and minocycline, are also believed to contribute to improvement of acne.
• Progressive concerns regarding emergence of P. acnes, commensal organisms, and potentially pathogenic bacteria in patients undergoing chronic antibiotic therapy, especially with an oral agent, warrants further study regarding issues related to antibiotics commonly prescribed by dermatologists, especially for chronic use.
• Although topical and oral antibiotic therapy may impact the microbiologic activity of skin and nares, data are more limited with topical antibiotic use, especially with regard to clinical significance. Further study is needed in this area to better differentiate implications that may be clinically significant to both individual patients and the general population.
• Presence of less sensitive P. acnes organisms contribute to decreased efficacy of antibiotic treatment in some patients, especially if a high density of less sensitive strains are present. However, oral antibiotics such as doxycycline and minocycline, and topical clindamycin, have continued to maintain efficacy in many patients, especially when used in appropriate combination with other agents (for example, benzoyl peroxide and topical retinoids).
Comparing Moisturization Potential
A comparison of two acne gels.
A two-part study was designed to compare the moisturization potential of two acne gels, both of which contain 5% benzoyl peroxide and 1% clindamycin. One of the acne gels contains dimethicone and glycerin.
In the first study, which was a 4-hour moisturization study, each volar forearm had one site that was treated with one of the acne gels (one gel on the left forearm and the other gel on the right forearm) and one site serving as an untreated control. Electrical conductance measurements were taken at baseline and 4 hours after treatment to measure skin surface hydration.
In the second study, which was an 8-day moisturization study, baseline electrical conductance measurements and water loss measurements were take at two volar forearm sites (one on each arm) and the sites were assessed for dryness and erythema by an expert grader. Each site was then treated with one of the acne gels for 8 days and conductance water loss measurements and dryness and erythema assessments were performed on day 8 before treatment and 4 hours post-treatment.
Results
For the 4-hour study, 31 females were enrolled and completed the study. Skin surfaced hydration, as measured by electrical conductance, was significantly (p<0.00001) reduced from baseline levels 4 hours post-treatment with both gels. Skin treated with the gel containing glycerin/dimethicone was significantly (p<0.00001) more hydrated, as measured by net chance from baseline
in electrical conductance, at 4 hours post-treatment as compared to the skin treated with the gel without glycerin/dimethicone.
In the 8-day study, 28 females were enrolled and 23 completed the study. The was no significant difference between treatments, according to the expert grader’s assessment of dryness and erythema on day 8. There was no significant decrease in skin surface hydration, measured by electrical conductance, after 8 days of treatment with the gel containing glycerin/dimethicone while treatment with the gel without glycerin/dimethicone resulted in significant (p<0.05) decrease in skin surface hydration. Treatment with the gel containing glycerin/dimethicone resulted in significantly (p<0.05) lower mean water loss value at day 8 (before treatment) compared to baseline.
Poster Authors: Charles Zerweck, Ph.D., Gary L. Grove, Ph.D., and Joanne M. Fraser, Ph.D.
Oracea Approved to Treat Rosacea
An alternative to systemic antibiotics.
CollaGenex Pharmaceuticals recently launched its 40-mg, slow-release doxycycline (Oracea), which was just FDA-approved as the first orally administered, systemically delivered drug for the treatment of the inflammatory lesions of rosacea in adult patients.
Oracea is the first alternative to systemic antibiotics. According to CollaGenex, the unique formulation of 40-mg doxycycline maintains the blood plasma concentration of the drug below the threshold for antimicrobial effect. This dose is anti-inflammatory without antibiotic activity, so there are no potential issues regarding emergence of antibiotic resistance, especially with long-term administration. A lack of antimicrobial activity has been confirmed based on pharmacokinetic data and microbiologic studies completed over durations of up to 18 months. The side effects were similar to placebo. Also, photosensitivity and vaginal candidiasis were not seen in clinical trials, further supporting the lack of antimicrobial activity.
Clinical Trials
In two double-blinded, placebo-controlled Phase III clinical studies, patients were administered either Oracea or placebo once a day for 16 weeks. For the study, 537 patients were enrolled in 28 centers across the United States. Both studies achieved their primary endpoint by demonstrating a greater reduction in inflammatory lesion count from baseline for the Oracea-treated patients compared to the placebo group.
In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients received placebo. The differences were clinically and statistically highly significant (p<0.001) in each study.
A separate clinical trial of 266 patients, evaluated the safety of Oracea over a 9-month period. This study demonstrated that the side effects of Oracea were comparable to placebo over a longer period of time. Safety beyond 9 months has not yet been established.
Tretinoin Microsphere Gel 0.04% with Clindamycin Phosphate 1% Foam
Evaluating the benefit of combination therapy.
An investigator-blinded, randomized, 10-week trial was conducted to evaluate the comparative efficacy of once-daily tretinoin microsphere gel 0.04% and clindamycin phosphate 1% foam used concomitantly versus once-daily clindamycin phosphate 1% foam monotherapy for the treatment of moderate truncal acne vulgaris in adult patients. The tolerability of the combination therapy in comparison to monotherapy was also assessed. Patients had to be 16 years of age or older with acne vulgaris of the back, with or without chest involvement. Patients had 10 to 25 superficial inflammatory lesions and two or fewer nodules and 10 or more non-inflammatory lesions.
Patients were excluded if they used topical therapy within 2 weeks of the start of the study, systemic antibiotic therapy within 4 weeks of the study start or oral isotretinoin within 6 months of the study. Patients were also excluded if they had a history of sensitivity or intolerance to medications or products used in the study or any medical condition with the potential to interfere with the study.
Eligible patients were randomized into two groups:
• Group A: Clindamycin 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening.
• Group B: Clindamycin 1% foam once daily in the
morning.
Patients were assessed at baseline and weeks 2, 6 and 10 (+/- 5-day window) for efficacy and skin tolerability.
Results
The mean reductions from baseline in inflammatory lesion count at weeks 6 and 10 were 63.6% and 72.7%, respectively, for Group A compared to 53.3% and 57.1%, respectively, for Group B.
The mean reductions from baseline in non-inflammatory lesion count at weeks 6 and 10 were 64.2% and 85.7%, respectively, for Group A compared to 43.7% and 56.2%, respectively, for Group B.
Investigator global assessment scores at week 10 varied from moderately clear to nearly clear in both groups.
The combination therapy of clindamycin phosphate 1% foam once daily in the morning and tretinoin 0.04% microsphere gel once daily in the evening produced a greater mean reduction in inflammatory and non-inflammatory truncal acne lesions than clindamycin phosphate 1% foam used as monotherapy. The combination therapy was well tolerated.
Poster Authors: James Q. Del Rosso, D.O., F.A.O.C.D., Neal Bhatia, M.D., Steve Hawkes, PA-C, and Lisa Sanglay, R.N.
