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Clindamycin gel, 1% once a day versus clindamycin solution, 1% twice a day and clindamycin gel vehicle in the treatment of acne vulgaris1
P49
P51
A DOUBLE-BLIND COMPARISON OF THE EFFICACY OF A SALICYLIC ACID BASED ACNE TREATMENT REGIMEN VERSUS A BENZOYL PEROXIDE BASED ACNE TREATMENT REGIMEN FOR THE TREATMENT OF ACNE VULGARIS Jacobson C Christine, BS, Stanford University, Stanford, CA, United States, Karina Arambula, BS, Stanford University, Stanford, CA, United States, Susan Chon, MD, Stanford University, Stanford, CA, United States, Alexa Kimball, MD, Stanford University, Stanford, CA, United States Context: Acne vulgaris affects between 40 and 50 million people in the United States including 85% or more of adolescents and young adults. Between 8-30% of adolescents seek medical care for their acne, leaving the majority to potentially use over-the-counter (OTC) acne treatment products. Benzoyl peroxide and salicylic acid are the most commonly used over-the-counter acne treatments. Unlike benzoyl peroxide, salicylic acid is approved worldwide for the treatment of acne due to its favorable side effect profile. Objectives: To compare salicylic acid (0.5%) and benzoyl peroxide (2.5%) based OTC acne treatment regimens in patients with mild to moderate acne vulgaris. The salicylic acid product also contains retinol and lactic acid and the benzoyl peroxide product contains glycolic acid. Design, Setting, and Participants: A total of 38 male and female subjects between 13-35 years of age with mild to moderate acne vulgaris completed the study. Patients had a mean total lesion count of 65, with a mean of 15 inflammatory lesions (range 4-60) and a mean of 51 non-inflammatory lesions (range 8-264). Main Outcome Measures: Change in the number of inflammatory lesions, non-inflammatory lesions and total acne lesions. Methods: Assessments were performed at baseline and at weeks 2, 6 and 12. Results: The number of non-inflammatory lesions decreased from 38 to 17 (57%) in the benzoyl peroxide arm and from 62 to 49 (21%) in the salicylic acid arm (p ⫽ 0.04), mostly due to an improvement in closed comedones over time (p ⫽ 0.03). However, salicylic acid and benzoyl peroxide demonstrated equivalent performance in improvement of inflammatory lesions. Additionally more patients treated with benzoyl peroxide had skin dryness than those treated with salicylic acid (12 v. 3, p ⬍ 0.01). There were no statistically significant intragroup differences when assessing change in total lesion count, quality of life measures, or evaluations of erythema, edema, dryness or hyperpigmentation over the course of the study. Conclusions: Salicylic acid and benzoyl peroxide showed equivalent performance in inflammatory lesion count. The benzoyl peroxide (2.5%) acne treatment regimen demonstrated an improvement over the salicylic acid (0.5%) acne treatment regimen in the non-inflammatory lesion count. Low concentrations of salicylic acid were less drying than benzoyl peroxide and therefore salicylic acid may be better tolerated over time.
THE MAINTENANCE EFFECT OF A TREATMENT WITH ADAPALENE GEL, 0.1% IN PATIENTS WITH ACNE VULGARIS Jianzhong Zang, MD, People Hospital Of Bejing/Galderma SA, Beijing, China, LL Feng, 3rd Hospital of Peking University, Beijing, China, TY Ting, Union Hospital of Wuhan, Wuhan, China, Z Jie, Ruijin Hospital, Shangai, China Objective: To assess the maintenance effect of adapalene gel, 0.1% in acne vulgaris subjects previously treated with clindamycin topical solution, 1% ⫹ adapalene gel, 0.1% or clindamycin topical solution alone, 1%. Methods: Multicentre, open label efficacy 12 weeks comparison in subjects receiving adapalene gel, 0.1% or no treatment. Subjects were included based on successful efficacy results in the previous study. Counts of total lesions, inflammatory lesions and noninflammatory lesions, global assessment of severity as well as the scoping of erythema, stinging/burning, scaling and dryness were performed throughout the study. Results: A total of 246 subjects were enrolled and 239 subjects completed the clinical evaluations. At week 12 the mean percent reductions from baseline for total, inflammatory and non-inflammatory lesion counts were 41.6%, 41.7% and 40.8% respectively in adapalene group; in the control group the mean percent increase at week 12 for total, inflammatory and non-inflammatory lesion counts were 92.1%, 97.1% and 87.7% respectively. At week 12, the global improvement was statistically significant between the two groups, favoring adapalene. Global improvement rate was 67.2% in the adapalene group compared to 4.2% in the control group (p ⬍ 0.01); the global relapse rate was 4.1% with adapalene group compared to 84.0% in the control group (p ⬍ 0.01). There were few mild local reactions. No systemic adverse event and no serious adverse event were reported. Conclusions: This study underlines the importance of a maintenance therapy after a partial or complete clearance of moderate to moderately severe acne with an initial acne treatment. Adapalene gel 0.1% decreases significantly the number of relapses and is effective and safe in the maintenance treatment for acne vulgaris. Disclosure not available at press time. Study granted by Galderma SA.
Dr Kimball has received honorarium from Nu Skin for advisory board work and speaking engagements. The Stanford Medical Scholars Program and Nu Skin provided funding for this study.
P50
P52 CLINDAMYCIN GEL, 1% ONCE A DAY VERSUS CLINDAMYCIN SOLUTION, 1% TWICE A DAY AND CLINDAMYCIN GEL VEHICLE IN THE TREATMENT OF ACNE VULGARIS Mohsen Alirezaı¨, MD, CHU Saint Eloi, Montpellier, France, B Gerlach, MD, Berlin, Germany, A Horvath, MD, Budapest, Hungary, D Forsea, MD, Bucarest, Romania Objectives: To demonstrate the similarity of clinical efficacy and to assess the safety of clindamycin gel, 1% once a day versus clindamycin solution, 1% twice a day, and to demonstrate the superior efficacy of clindamycin gel, 1% versus its vehicle. Methods: A multi center, investigator-masked, randomized, active and placebo-controlled, active-controlled, parallel group study. Subjects were treated for 12 weeks and were evaluated at baseline and at week 4, 8 and 12. Results: A total of 592 subjects were included. A 65% reduction in inflammatory lesions count was observed after 12 weeks of treatment for both active treatments. Superiority analysis showed that the gel was superior to its vehicle for inflammatory lesions count reduction and Global Assessment of Improvement at final visit (p ⫽ 0.006 and p ⫽ 0.039 respectively). Percent reduction from baseline in total lesion count at endpoint showed no statistically significant difference between both active treatments (p ⫽ 0.134) but a significant difference between clindamycin gel 1% and its vehicle (p ⫽ 0.009). No difference was found between the two active treatments for global improvement and for the global severity grade at endpoint. A significant difference was found between gel and its vehicle for global severity grade (p ⫽ 0.002). The reduction in the inflammatory lesions count observed after a 12-week treatment was 65.6% for both gel and solution in the PP population. A total of 48 (8.1%) subjects experienced a total of 59 AEs. These were equally distributed between the three treatment groups: 22 (8.3%) subjects in the gel group, 22 (8.4%) in the solution group and in the gel vehicle group (4 subjects, 6.1%). Local tolerance for dermatological related AEs in each active treatment group was better in the gel group (1.9%) compared to the solution group (8.4%). Conclusion: Clindamycin gel, 1% once a day showed a similar efficacy profile than clindamycin solution, 1% twice a day in the treatment of mild to moderate acne vulgaris and was significantly superior to its vehicle and has a better safety profile compared to that of clindamycin solution 1%. Disclosure not available at press time. The study was granted by Galderma R&D.
MARCH 2004
J AM ACAD DERMATOL
P13
P51
A DOUBLE-BLIND COMPARISON OF THE EFFICACY OF A SALICYLIC ACID BASED ACNE TREATMENT REGIMEN VERSUS A BENZOYL PEROXIDE BASED ACNE TREATMENT REGIMEN FOR THE TREATMENT OF ACNE VULGARIS Jacobson C Christine, BS, Stanford University, Stanford, CA, United States, Karina Arambula, BS, Stanford University, Stanford, CA, United States, Susan Chon, MD, Stanford University, Stanford, CA, United States, Alexa Kimball, MD, Stanford University, Stanford, CA, United States Context: Acne vulgaris affects between 40 and 50 million people in the United States including 85% or more of adolescents and young adults. Between 8-30% of adolescents seek medical care for their acne, leaving the majority to potentially use over-the-counter (OTC) acne treatment products. Benzoyl peroxide and salicylic acid are the most commonly used over-the-counter acne treatments. Unlike benzoyl peroxide, salicylic acid is approved worldwide for the treatment of acne due to its favorable side effect profile. Objectives: To compare salicylic acid (0.5%) and benzoyl peroxide (2.5%) based OTC acne treatment regimens in patients with mild to moderate acne vulgaris. The salicylic acid product also contains retinol and lactic acid and the benzoyl peroxide product contains glycolic acid. Design, Setting, and Participants: A total of 38 male and female subjects between 13-35 years of age with mild to moderate acne vulgaris completed the study. Patients had a mean total lesion count of 65, with a mean of 15 inflammatory lesions (range 4-60) and a mean of 51 non-inflammatory lesions (range 8-264). Main Outcome Measures: Change in the number of inflammatory lesions, non-inflammatory lesions and total acne lesions. Methods: Assessments were performed at baseline and at weeks 2, 6 and 12. Results: The number of non-inflammatory lesions decreased from 38 to 17 (57%) in the benzoyl peroxide arm and from 62 to 49 (21%) in the salicylic acid arm (p ⫽ 0.04), mostly due to an improvement in closed comedones over time (p ⫽ 0.03). However, salicylic acid and benzoyl peroxide demonstrated equivalent performance in improvement of inflammatory lesions. Additionally more patients treated with benzoyl peroxide had skin dryness than those treated with salicylic acid (12 v. 3, p ⬍ 0.01). There were no statistically significant intragroup differences when assessing change in total lesion count, quality of life measures, or evaluations of erythema, edema, dryness or hyperpigmentation over the course of the study. Conclusions: Salicylic acid and benzoyl peroxide showed equivalent performance in inflammatory lesion count. The benzoyl peroxide (2.5%) acne treatment regimen demonstrated an improvement over the salicylic acid (0.5%) acne treatment regimen in the non-inflammatory lesion count. Low concentrations of salicylic acid were less drying than benzoyl peroxide and therefore salicylic acid may be better tolerated over time.
THE MAINTENANCE EFFECT OF A TREATMENT WITH ADAPALENE GEL, 0.1% IN PATIENTS WITH ACNE VULGARIS Jianzhong Zang, MD, People Hospital Of Bejing/Galderma SA, Beijing, China, LL Feng, 3rd Hospital of Peking University, Beijing, China, TY Ting, Union Hospital of Wuhan, Wuhan, China, Z Jie, Ruijin Hospital, Shangai, China Objective: To assess the maintenance effect of adapalene gel, 0.1% in acne vulgaris subjects previously treated with clindamycin topical solution, 1% ⫹ adapalene gel, 0.1% or clindamycin topical solution alone, 1%. Methods: Multicentre, open label efficacy 12 weeks comparison in subjects receiving adapalene gel, 0.1% or no treatment. Subjects were included based on successful efficacy results in the previous study. Counts of total lesions, inflammatory lesions and noninflammatory lesions, global assessment of severity as well as the scoping of erythema, stinging/burning, scaling and dryness were performed throughout the study. Results: A total of 246 subjects were enrolled and 239 subjects completed the clinical evaluations. At week 12 the mean percent reductions from baseline for total, inflammatory and non-inflammatory lesion counts were 41.6%, 41.7% and 40.8% respectively in adapalene group; in the control group the mean percent increase at week 12 for total, inflammatory and non-inflammatory lesion counts were 92.1%, 97.1% and 87.7% respectively. At week 12, the global improvement was statistically significant between the two groups, favoring adapalene. Global improvement rate was 67.2% in the adapalene group compared to 4.2% in the control group (p ⬍ 0.01); the global relapse rate was 4.1% with adapalene group compared to 84.0% in the control group (p ⬍ 0.01). There were few mild local reactions. No systemic adverse event and no serious adverse event were reported. Conclusions: This study underlines the importance of a maintenance therapy after a partial or complete clearance of moderate to moderately severe acne with an initial acne treatment. Adapalene gel 0.1% decreases significantly the number of relapses and is effective and safe in the maintenance treatment for acne vulgaris. Disclosure not available at press time. Study granted by Galderma SA.
Dr Kimball has received honorarium from Nu Skin for advisory board work and speaking engagements. The Stanford Medical Scholars Program and Nu Skin provided funding for this study.
P50
P52 CLINDAMYCIN GEL, 1% ONCE A DAY VERSUS CLINDAMYCIN SOLUTION, 1% TWICE A DAY AND CLINDAMYCIN GEL VEHICLE IN THE TREATMENT OF ACNE VULGARIS Mohsen Alirezaı¨, MD, CHU Saint Eloi, Montpellier, France, B Gerlach, MD, Berlin, Germany, A Horvath, MD, Budapest, Hungary, D Forsea, MD, Bucarest, Romania Objectives: To demonstrate the similarity of clinical efficacy and to assess the safety of clindamycin gel, 1% once a day versus clindamycin solution, 1% twice a day, and to demonstrate the superior efficacy of clindamycin gel, 1% versus its vehicle. Methods: A multi center, investigator-masked, randomized, active and placebo-controlled, active-controlled, parallel group study. Subjects were treated for 12 weeks and were evaluated at baseline and at week 4, 8 and 12. Results: A total of 592 subjects were included. A 65% reduction in inflammatory lesions count was observed after 12 weeks of treatment for both active treatments. Superiority analysis showed that the gel was superior to its vehicle for inflammatory lesions count reduction and Global Assessment of Improvement at final visit (p ⫽ 0.006 and p ⫽ 0.039 respectively). Percent reduction from baseline in total lesion count at endpoint showed no statistically significant difference between both active treatments (p ⫽ 0.134) but a significant difference between clindamycin gel 1% and its vehicle (p ⫽ 0.009). No difference was found between the two active treatments for global improvement and for the global severity grade at endpoint. A significant difference was found between gel and its vehicle for global severity grade (p ⫽ 0.002). The reduction in the inflammatory lesions count observed after a 12-week treatment was 65.6% for both gel and solution in the PP population. A total of 48 (8.1%) subjects experienced a total of 59 AEs. These were equally distributed between the three treatment groups: 22 (8.3%) subjects in the gel group, 22 (8.4%) in the solution group and in the gel vehicle group (4 subjects, 6.1%). Local tolerance for dermatological related AEs in each active treatment group was better in the gel group (1.9%) compared to the solution group (8.4%). Conclusion: Clindamycin gel, 1% once a day showed a similar efficacy profile than clindamycin solution, 1% twice a day in the treatment of mild to moderate acne vulgaris and was significantly superior to its vehicle and has a better safety profile compared to that of clindamycin solution 1%. Disclosure not available at press time. The study was granted by Galderma R&D.
MARCH 2004
J AM ACAD DERMATOL
P13