A bout 14 million Americans have rosacea. And almost everyone has had acne at some point in his or her life. These two conditions probably present in your office very frequently — and as you know affect both the skin and self-esteem of most patients. Fortunately, there’s a host of new research on methods for treating acne and rosacea. In this article, we’ll report on research presented at the American Academy of Dermatology (AAD) annual meeting in March and summer meeting in July, as well as research from other sources. Best Dose for Acne Treatment Results of Dose-Response Study with Oral Tazarotene Results of a multicenter, double-blind, randomized, placebo-controlled, parallel group study, researchers found oral tazarotene to be effective for nodulocystic acne at once-daily doses of 1.5 mg, 3 mg, and 6 mg, with maintenance for at least 12 weeks. Results of the study were presented at the AAD meeting in July. For this study, 181 patients older than 16 with at least seven facial nodulocystic acne lesions were enrolled. Patients were randomized to receive placebo or oral tazarotene (0.75 mg, 1.5 mg, 3 mg or 6 mg) in a 1:1:1:1:1 ratio once a day for 24 weeks. After the treatment period, patients were followed without treatment for 12 weeks. Patients who didn’t complete the 24-week treatment period because of adverse effects or lack of efficacy were still eligible for entry into post-treatment phase. Of the 181 patients enrolled, 127 completed 24-week treatment. Of 145 patients who entered 12-week post-treatment phase, 96 completed it. The mean number of lesions at baseline ranged from 10.8 to 12.2 in the treatment groups. There were no significant differences between the groups at baseline in demographics or measures of acne severity. Outcome was measured by improvement in acne severity, facial nodulocystic lesion count of >5 mm, facial papular/pustular lesion count of >=5 mm and facial non-inflammatory lesion count (open and closed comedones). Treatment success was defined as at least moderate (about 50%) improvement on a 7-point global response scale. Here’s a look at the research highlights: • Tazarotene 6 mg reduced the overall acne severity significantly more than placebo from week 16 through end of post-treatment. (p<=0.01) • More than 45% of patients in the three highest dose groups had either no acne or mild acne by end of treatment phase, compared with 34% in the 0.75-mg group and 19% in the placebo group. At the end of post-treatment, these levels had been maintained in 53% of 6-mg group and 43% of 3-mg group. • In terms of clearing of nodulocystic acne at the end of the treatment period: the placebo group saw a 55% reduction, the 0.75-mg group saw a 66% reduction, the 1.5-mg group saw a 73% reduction, the 3-mg group saw a 79% reduction and the 6-mg group saw an 86% reduction. • At the end of the treatment period, the mean facial non-inflammatory lesion count was reduced from: • 62.3 to 34.2 in placebo group (45% reduction) • 56.3 to 30.3 in the 0.75-group (46% reduction) • 59.2 to 17.8 in the 1.5-mg group (70% reduction) • 56.1 to 21.3 in the 3-mg group (62% reduction) • 47.7 to 13.5 in the 6-mg group (72% reduction). Assessing Rosacea A New Static Score System It’s becoming standard to use defined static scores for the investigator’s global assessment (IGA) of outcomes of therapeutic trials in dermatology. These static scores describe the clinical status of a patient at one point in time without reference to baseline. Research experience with a new 7-point static score to globally assess the severity of Stage 2 papulopustular rosacea was presented at the Annual AAD meeting in March. Simulated treatment groups (totaling 664 patients) were selected at random using data from two large, vehicle-controlled, Phase III studies comparing azelaic acid 15% gel (Finacea) with its vehicle. The 7-point system of the IGA is made up of an integrated severity description of inflammatory lesions, erythema and telangiectasia. The severity of each individual symptom was also rated on a dynamic 4-point scale (no sign to severe), and the investigator’s overall assessment of improvement at the end of treatment was rated on a 5-point scale (deterioration to complete remission. Investigators were trained prior to the study, and used the 7-point scale to evaluate severity of rosacea at baseline and at each follow-up visit. Investigators concluded that the new static IGA scale is valuable in assessing the severity of rosacea. Combination Therapy for Moderate Rosacea A Viable Treatment Option In an effort to determine the efficacy and tolerability of benzoyl peroxide/ clindamycin (Benzaclin, Duac) for the treatment of moderate rosacea, a randomized, double-blind, multicenter, placebo-controlled study was conducted. During this 12-week study, 53 patients were randomized to apply BP/C or placebo gel topically once a day on the face. Clinical evaluations and photographs were taken at baseline and at weeks 3, 6, 9 and 12. Efficacy viability included change from baseline in papule and pustule count, in rosacea signs and symptoms, in Overall Rosacea Severity Assessment (ORSA), in Physician’s Global Assessment (PGA) and in Patient’s Global Assessment (PtGA). Some of the results are included below: • Patients treated with BP/C experienced a >70% reduction in papules and pustules by week 6, which was maintained throughout the 12-week period. This was significantly greater (p<=0.02) than the placebo group. • BP/C patients experienced significant (p<0.001) reduction in erythema, flushing and blushing, lesions and overall severity compared to placebo group. • ORSA improved by 30% in BP/C group, compared to a 10% improvement in placebo group. • Improvements in PGA was significantly higher in BP/C group than placebo (92.3% versus 69.2%). Phase II Study Results Released A Promising Adjunctive Therapy for Rosacea A Phase II study to evaluate the efficacy of metronidazole 0.75% (Metro-Lotion) combined with doxycycline hyclate 20 mg (Periostat) versus MetroLotion and placebo for the treatment of rosacea was conducted by Jorge Sanchez, M.D., Professor of Dermatology at the University of Puerto Rico. Forty patients were randomized into the two treatment groups and treated for 12 weeks with their respective combination. After 12 weeks, patients discontinued the use of MetroLotion and were maintained on Periostat or placebo for 4 weeks. Lesion count and an assessment of erythema and overall clinical disease severity were obtained at baseline and weeks 4, 8, 12 and 16. At week 12 there was 59% reduction in lesion count in the MetroLotion/ Periostat group, while the MetroLotion/placebo group saw a 34% reduction. The patients who were maintained on the Periostat for 4 weeks retained the improvements they saw at week 12, while the placebo group showed deterioration in improvement. Medical Management of Rosacea A Review of Available Topical Agents Since receiving FDA approval in December 2002, azelaic acid 15% (Finacea) has been added to the first-tier topical agents for treatment of rosacea, according to published data by James Q. Del Rosso, D.O., F.A.O.C.D., at the Annual AAD meeting in March. Based on a review of first- and second-tier topical agents and supporting research, this presentation concluded: • Selection of initial therapy should be based on disease presentation and severity. You should choose a 2-month to 3-month trial of a first-tier topical agent for mild to moderate rosacea. These include: topical metronidazole (Metro-Cream, MetroGel, Metro-Lotion, Noritate); sulfacetamide 10%/Sulfur 5% (Rosanil); and azelaic acid 15%. • Having multiple choices available is beneficial in cases of treatment failure or partial response. • More scientific evidence is needed, but combination therapy using different topical agents is likely to occur and may enhance the therapeutic efficacy. Sulfacetamide 10%/Sulfur 5% cleanser used once or twice per day with another topical therapy may enhance the overall benefit of therapy. • Availability of different vehicles allows for flexibility and correlation with “skin type” and patient preference. • If a patient with rosacea needs oral antibiotic therapy, you should also treat the patient with a topical agent. Maintenance with the topical agent after rosacea is controlled may allow for discontinuation or tapering of doses of oral antibiotics.
Research Highlights of Acne and Rosacea Treatments
A bout 14 million Americans have rosacea. And almost everyone has had acne at some point in his or her life. These two conditions probably present in your office very frequently — and as you know affect both the skin and self-esteem of most patients. Fortunately, there’s a host of new research on methods for treating acne and rosacea. In this article, we’ll report on research presented at the American Academy of Dermatology (AAD) annual meeting in March and summer meeting in July, as well as research from other sources. Best Dose for Acne Treatment Results of Dose-Response Study with Oral Tazarotene Results of a multicenter, double-blind, randomized, placebo-controlled, parallel group study, researchers found oral tazarotene to be effective for nodulocystic acne at once-daily doses of 1.5 mg, 3 mg, and 6 mg, with maintenance for at least 12 weeks. Results of the study were presented at the AAD meeting in July. For this study, 181 patients older than 16 with at least seven facial nodulocystic acne lesions were enrolled. Patients were randomized to receive placebo or oral tazarotene (0.75 mg, 1.5 mg, 3 mg or 6 mg) in a 1:1:1:1:1 ratio once a day for 24 weeks. After the treatment period, patients were followed without treatment for 12 weeks. Patients who didn’t complete the 24-week treatment period because of adverse effects or lack of efficacy were still eligible for entry into post-treatment phase. Of the 181 patients enrolled, 127 completed 24-week treatment. Of 145 patients who entered 12-week post-treatment phase, 96 completed it. The mean number of lesions at baseline ranged from 10.8 to 12.2 in the treatment groups. There were no significant differences between the groups at baseline in demographics or measures of acne severity. Outcome was measured by improvement in acne severity, facial nodulocystic lesion count of >5 mm, facial papular/pustular lesion count of >=5 mm and facial non-inflammatory lesion count (open and closed comedones). Treatment success was defined as at least moderate (about 50%) improvement on a 7-point global response scale. Here’s a look at the research highlights: • Tazarotene 6 mg reduced the overall acne severity significantly more than placebo from week 16 through end of post-treatment. (p<=0.01) • More than 45% of patients in the three highest dose groups had either no acne or mild acne by end of treatment phase, compared with 34% in the 0.75-mg group and 19% in the placebo group. At the end of post-treatment, these levels had been maintained in 53% of 6-mg group and 43% of 3-mg group. • In terms of clearing of nodulocystic acne at the end of the treatment period: the placebo group saw a 55% reduction, the 0.75-mg group saw a 66% reduction, the 1.5-mg group saw a 73% reduction, the 3-mg group saw a 79% reduction and the 6-mg group saw an 86% reduction. • At the end of the treatment period, the mean facial non-inflammatory lesion count was reduced from: • 62.3 to 34.2 in placebo group (45% reduction) • 56.3 to 30.3 in the 0.75-group (46% reduction) • 59.2 to 17.8 in the 1.5-mg group (70% reduction) • 56.1 to 21.3 in the 3-mg group (62% reduction) • 47.7 to 13.5 in the 6-mg group (72% reduction). Assessing Rosacea A New Static Score System It’s becoming standard to use defined static scores for the investigator’s global assessment (IGA) of outcomes of therapeutic trials in dermatology. These static scores describe the clinical status of a patient at one point in time without reference to baseline. Research experience with a new 7-point static score to globally assess the severity of Stage 2 papulopustular rosacea was presented at the Annual AAD meeting in March. Simulated treatment groups (totaling 664 patients) were selected at random using data from two large, vehicle-controlled, Phase III studies comparing azelaic acid 15% gel (Finacea) with its vehicle. The 7-point system of the IGA is made up of an integrated severity description of inflammatory lesions, erythema and telangiectasia. The severity of each individual symptom was also rated on a dynamic 4-point scale (no sign to severe), and the investigator’s overall assessment of improvement at the end of treatment was rated on a 5-point scale (deterioration to complete remission. Investigators were trained prior to the study, and used the 7-point scale to evaluate severity of rosacea at baseline and at each follow-up visit. Investigators concluded that the new static IGA scale is valuable in assessing the severity of rosacea. Combination Therapy for Moderate Rosacea A Viable Treatment Option In an effort to determine the efficacy and tolerability of benzoyl peroxide/ clindamycin (Benzaclin, Duac) for the treatment of moderate rosacea, a randomized, double-blind, multicenter, placebo-controlled study was conducted. During this 12-week study, 53 patients were randomized to apply BP/C or placebo gel topically once a day on the face. Clinical evaluations and photographs were taken at baseline and at weeks 3, 6, 9 and 12. Efficacy viability included change from baseline in papule and pustule count, in rosacea signs and symptoms, in Overall Rosacea Severity Assessment (ORSA), in Physician’s Global Assessment (PGA) and in Patient’s Global Assessment (PtGA). Some of the results are included below: • Patients treated with BP/C experienced a >70% reduction in papules and pustules by week 6, which was maintained throughout the 12-week period. This was significantly greater (p<=0.02) than the placebo group. • BP/C patients experienced significant (p<0.001) reduction in erythema, flushing and blushing, lesions and overall severity compared to placebo group. • ORSA improved by 30% in BP/C group, compared to a 10% improvement in placebo group. • Improvements in PGA was significantly higher in BP/C group than placebo (92.3% versus 69.2%). Phase II Study Results Released A Promising Adjunctive Therapy for Rosacea A Phase II study to evaluate the efficacy of metronidazole 0.75% (Metro-Lotion) combined with doxycycline hyclate 20 mg (Periostat) versus MetroLotion and placebo for the treatment of rosacea was conducted by Jorge Sanchez, M.D., Professor of Dermatology at the University of Puerto Rico. Forty patients were randomized into the two treatment groups and treated for 12 weeks with their respective combination. After 12 weeks, patients discontinued the use of MetroLotion and were maintained on Periostat or placebo for 4 weeks. Lesion count and an assessment of erythema and overall clinical disease severity were obtained at baseline and weeks 4, 8, 12 and 16. At week 12 there was 59% reduction in lesion count in the MetroLotion/ Periostat group, while the MetroLotion/placebo group saw a 34% reduction. The patients who were maintained on the Periostat for 4 weeks retained the improvements they saw at week 12, while the placebo group showed deterioration in improvement. Medical Management of Rosacea A Review of Available Topical Agents Since receiving FDA approval in December 2002, azelaic acid 15% (Finacea) has been added to the first-tier topical agents for treatment of rosacea, according to published data by James Q. Del Rosso, D.O., F.A.O.C.D., at the Annual AAD meeting in March. Based on a review of first- and second-tier topical agents and supporting research, this presentation concluded: • Selection of initial therapy should be based on disease presentation and severity. You should choose a 2-month to 3-month trial of a first-tier topical agent for mild to moderate rosacea. These include: topical metronidazole (Metro-Cream, MetroGel, Metro-Lotion, Noritate); sulfacetamide 10%/Sulfur 5% (Rosanil); and azelaic acid 15%. • Having multiple choices available is beneficial in cases of treatment failure or partial response. • More scientific evidence is needed, but combination therapy using different topical agents is likely to occur and may enhance the therapeutic efficacy. Sulfacetamide 10%/Sulfur 5% cleanser used once or twice per day with another topical therapy may enhance the overall benefit of therapy. • Availability of different vehicles allows for flexibility and correlation with “skin type” and patient preference. • If a patient with rosacea needs oral antibiotic therapy, you should also treat the patient with a topical agent. Maintenance with the topical agent after rosacea is controlled may allow for discontinuation or tapering of doses of oral antibiotics.
A bout 14 million Americans have rosacea. And almost everyone has had acne at some point in his or her life. These two conditions probably present in your office very frequently — and as you know affect both the skin and self-esteem of most patients. Fortunately, there’s a host of new research on methods for treating acne and rosacea. In this article, we’ll report on research presented at the American Academy of Dermatology (AAD) annual meeting in March and summer meeting in July, as well as research from other sources. Best Dose for Acne Treatment Results of Dose-Response Study with Oral Tazarotene Results of a multicenter, double-blind, randomized, placebo-controlled, parallel group study, researchers found oral tazarotene to be effective for nodulocystic acne at once-daily doses of 1.5 mg, 3 mg, and 6 mg, with maintenance for at least 12 weeks. Results of the study were presented at the AAD meeting in July. For this study, 181 patients older than 16 with at least seven facial nodulocystic acne lesions were enrolled. Patients were randomized to receive placebo or oral tazarotene (0.75 mg, 1.5 mg, 3 mg or 6 mg) in a 1:1:1:1:1 ratio once a day for 24 weeks. After the treatment period, patients were followed without treatment for 12 weeks. Patients who didn’t complete the 24-week treatment period because of adverse effects or lack of efficacy were still eligible for entry into post-treatment phase. Of the 181 patients enrolled, 127 completed 24-week treatment. Of 145 patients who entered 12-week post-treatment phase, 96 completed it. The mean number of lesions at baseline ranged from 10.8 to 12.2 in the treatment groups. There were no significant differences between the groups at baseline in demographics or measures of acne severity. Outcome was measured by improvement in acne severity, facial nodulocystic lesion count of >5 mm, facial papular/pustular lesion count of >=5 mm and facial non-inflammatory lesion count (open and closed comedones). Treatment success was defined as at least moderate (about 50%) improvement on a 7-point global response scale. Here’s a look at the research highlights: • Tazarotene 6 mg reduced the overall acne severity significantly more than placebo from week 16 through end of post-treatment. (p<=0.01) • More than 45% of patients in the three highest dose groups had either no acne or mild acne by end of treatment phase, compared with 34% in the 0.75-mg group and 19% in the placebo group. At the end of post-treatment, these levels had been maintained in 53% of 6-mg group and 43% of 3-mg group. • In terms of clearing of nodulocystic acne at the end of the treatment period: the placebo group saw a 55% reduction, the 0.75-mg group saw a 66% reduction, the 1.5-mg group saw a 73% reduction, the 3-mg group saw a 79% reduction and the 6-mg group saw an 86% reduction. • At the end of the treatment period, the mean facial non-inflammatory lesion count was reduced from: • 62.3 to 34.2 in placebo group (45% reduction) • 56.3 to 30.3 in the 0.75-group (46% reduction) • 59.2 to 17.8 in the 1.5-mg group (70% reduction) • 56.1 to 21.3 in the 3-mg group (62% reduction) • 47.7 to 13.5 in the 6-mg group (72% reduction). Assessing Rosacea A New Static Score System It’s becoming standard to use defined static scores for the investigator’s global assessment (IGA) of outcomes of therapeutic trials in dermatology. These static scores describe the clinical status of a patient at one point in time without reference to baseline. Research experience with a new 7-point static score to globally assess the severity of Stage 2 papulopustular rosacea was presented at the Annual AAD meeting in March. Simulated treatment groups (totaling 664 patients) were selected at random using data from two large, vehicle-controlled, Phase III studies comparing azelaic acid 15% gel (Finacea) with its vehicle. The 7-point system of the IGA is made up of an integrated severity description of inflammatory lesions, erythema and telangiectasia. The severity of each individual symptom was also rated on a dynamic 4-point scale (no sign to severe), and the investigator’s overall assessment of improvement at the end of treatment was rated on a 5-point scale (deterioration to complete remission. Investigators were trained prior to the study, and used the 7-point scale to evaluate severity of rosacea at baseline and at each follow-up visit. Investigators concluded that the new static IGA scale is valuable in assessing the severity of rosacea. Combination Therapy for Moderate Rosacea A Viable Treatment Option In an effort to determine the efficacy and tolerability of benzoyl peroxide/ clindamycin (Benzaclin, Duac) for the treatment of moderate rosacea, a randomized, double-blind, multicenter, placebo-controlled study was conducted. During this 12-week study, 53 patients were randomized to apply BP/C or placebo gel topically once a day on the face. Clinical evaluations and photographs were taken at baseline and at weeks 3, 6, 9 and 12. Efficacy viability included change from baseline in papule and pustule count, in rosacea signs and symptoms, in Overall Rosacea Severity Assessment (ORSA), in Physician’s Global Assessment (PGA) and in Patient’s Global Assessment (PtGA). Some of the results are included below: • Patients treated with BP/C experienced a >70% reduction in papules and pustules by week 6, which was maintained throughout the 12-week period. This was significantly greater (p<=0.02) than the placebo group. • BP/C patients experienced significant (p<0.001) reduction in erythema, flushing and blushing, lesions and overall severity compared to placebo group. • ORSA improved by 30% in BP/C group, compared to a 10% improvement in placebo group. • Improvements in PGA was significantly higher in BP/C group than placebo (92.3% versus 69.2%). Phase II Study Results Released A Promising Adjunctive Therapy for Rosacea A Phase II study to evaluate the efficacy of metronidazole 0.75% (Metro-Lotion) combined with doxycycline hyclate 20 mg (Periostat) versus MetroLotion and placebo for the treatment of rosacea was conducted by Jorge Sanchez, M.D., Professor of Dermatology at the University of Puerto Rico. Forty patients were randomized into the two treatment groups and treated for 12 weeks with their respective combination. After 12 weeks, patients discontinued the use of MetroLotion and were maintained on Periostat or placebo for 4 weeks. Lesion count and an assessment of erythema and overall clinical disease severity were obtained at baseline and weeks 4, 8, 12 and 16. At week 12 there was 59% reduction in lesion count in the MetroLotion/ Periostat group, while the MetroLotion/placebo group saw a 34% reduction. The patients who were maintained on the Periostat for 4 weeks retained the improvements they saw at week 12, while the placebo group showed deterioration in improvement. Medical Management of Rosacea A Review of Available Topical Agents Since receiving FDA approval in December 2002, azelaic acid 15% (Finacea) has been added to the first-tier topical agents for treatment of rosacea, according to published data by James Q. Del Rosso, D.O., F.A.O.C.D., at the Annual AAD meeting in March. Based on a review of first- and second-tier topical agents and supporting research, this presentation concluded: • Selection of initial therapy should be based on disease presentation and severity. You should choose a 2-month to 3-month trial of a first-tier topical agent for mild to moderate rosacea. These include: topical metronidazole (Metro-Cream, MetroGel, Metro-Lotion, Noritate); sulfacetamide 10%/Sulfur 5% (Rosanil); and azelaic acid 15%. • Having multiple choices available is beneficial in cases of treatment failure or partial response. • More scientific evidence is needed, but combination therapy using different topical agents is likely to occur and may enhance the therapeutic efficacy. Sulfacetamide 10%/Sulfur 5% cleanser used once or twice per day with another topical therapy may enhance the overall benefit of therapy. • Availability of different vehicles allows for flexibility and correlation with “skin type” and patient preference. • If a patient with rosacea needs oral antibiotic therapy, you should also treat the patient with a topical agent. Maintenance with the topical agent after rosacea is controlled may allow for discontinuation or tapering of doses of oral antibiotics.
