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benzoyl peroxide 2.5% for acne vulgaris
P6087
P6707
Cross-study comparison of efficacy and safety of clindamycin 1%/tretinoin 0.025% and adapalene 0.1%/benzoyl peroxide 2.5% for acne vulgaris Montserrat Perez, MD, PhD, Clinica Dermatologica de Moragas, Barcelona, Spain
Efficacy and safety of a novel sonic brush head designed for cleansing acneic skin Emily Henes, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Katherine Ortblad, MBA, Pacific Bioscience Laboratories, Redmond, WA, United States; Lauri Tadlock, MD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Micheal Kearney, Pacific Bioscience Laboratories, Redmond, WA, United States; Nina Koski, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Robert Akridge, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States
Background: Fixed-dose combination therapies, such as clindamycin 1%/tretinoin 0.025% (Clin-RA) and adapalene 0.1%/benzoyl peroxide 2.5% (Adap-BPO), are more effective than their constituent monotherapies for the treatment of acne vulgaris. Clin-RA is formulated using novel technology to combine clindamycin with solubilized and crystalline tretinoin in a patented alcohol-free, aqueous based gel. The unique formulation characteristics may account for the favorable cutaneous tolerability profile and low irritation potential of Clin-RA compared to other retinoidbased products. The aim of this post-hoc cross-study analysis was to compare the efficacy, safety, and tolerability of Clin-RA and Adap-BPO. Methods: Data for Clin-RA came from a metaanalysis of 3 phase III studies involving a total of 4550 patients (1853 were treated with Clin-RA). Adap-BPO data came from 3 large phase III studies of a total of 3855 patients (553 received Adap-BPO). All studies were 12-week, randomized, double-blind and parallel group in design. Results: Clin-RA and Adap-BPO were similarly effective at reducing inflammatory (median % change from baseline: 65.2% vs 62.8% Adap-BPO study 1, 62.1% AdapBPO study 2, and 70.3% Adap-BPO study 3) and noninflammatory acne lesions (51.6% vs 51.2%, 53.8%, and 62.2%). A lower proportion of Clin-RA treated pts experienced worsening of erythema (25.4% vs 40.7%), scaling (35.8% vs 45.8%), and stinging/burning events (17.9% vs 59.3%) versus patients treated with AdapBPO (data from studies 1 and 2). In addition, Clin-RA was associated with lower rates of the following versus Adap-BPO (studies 1 and 2): application site burning (0.3% vs 2.7%), dry skin/application site dryness (2.1% vs 7.4%), contact dermatitis/application site dermatitis (0.3% vs 3.2%), and pruritus/application site pruritus (0.4% vs 1.2%). Conclusion: Within the limitations of a cross-study comparison, these results show that the unique formulation of Clin-RA is associated with comparable efficacy to Adap-BPO and indicate that it has an improved safety and tolerability profile. This may translate into better patient compliance and Clin-RA being preferred by patients. 100% supported by Meda Pharma GmbH and Co. KG.
Background: Delicate compromised skin caused by specific skin conditions presents cleansing challenges. Removal of dirt, oil, and bacteria without harming the function of the skin barrier are important when cleansing the skin. The efficacy and safety of a new extra gentle sonic brush head (GBH) to cleanse delicate compromised skin associated with skin conditions (ie, acne) was evaluated. Methods: Efficacy was assessed in a 2-visit, split-forehead, randomized study (n ¼ 20) using a sebum capture methodology (Sebutape indicator strips; CuDerm, Dallas, TX) and image analysis to compare the GBH to a sensitive sonic brush head (SBH). Safety/gentleness was assessed in a second randomized study (n ¼ 10) using an exfoliation leg tanning methodology. Transepidermal water loss (TEWL), melanin (M), skin moisture/hydration (H), and erythema (E) were assessed before/after exaggerated use of 3 test products (sonic skin care brush using the normal brush head [NBH], a GBH, and a nylon facial cleansing pad [BP]), as well as a nontreatment control area. Duplicate measurements of M, H, and E and triplicate measurements of TEWL were taken before/after treatment. Results: To evaluate efficacy sebum levels remaining after cleansing were quantified by using image analysis software (Image J 1.43; NIH). Results were compared statistically using a paired t test. Residual sebum analysis found no statistically significant difference (P ¼ .71) between the GBH and SBH. Parametric statistical methods were used to evaluate the safety/gentleness. TEWL measurements after using each product fell within the normal range previously established for skin on the lower leg. The reduction of M (post-pre) was similar between the 3 treatments; all were significantly different from the nontreatment control (P ¼ .01). A nonclinically significant change in E was observed after the treatment with the GBH; no significant differences in change from baseline were detected as compared to the untreated control with either brush head. Conclusion: Analysis confirmed the GBH is safe/gentle for daily use to cleanse delicate compromised skin associated with skin conditions (ie, acne). 100% is sponsored by Pacific Bioscience Laboratories.
P6404 Efficacy and safety of novel clindamycin 1%/tretinoin 0.025% formulation for acne vulgaris: Pooled analysis of 3 phase III studies Vincenzo Bettoli, MD, Department of Clinical and Experimental Medicine, Section of Dermatology, Azienda Ospedaliera Universitaria Arcispedale S. Anna, University of Ferrara, Ferrara, Italy Background: The foundation of therapy for most patients with acne is a topical retinoid because they reduce the formation of microcomedones. Combination therapies include an antimicrobial agent to provide synergy and optimise lesion clearance. The aim of this pooled analysis was to compare the efficacy and safety of a novel clindamycin 1%/tretinoin 0.025% (Clin-RA) gel formulation versus its constituent monotherapies and vehicle for the treatment of acne.
P6935 Double-blind, placebo-controlled study assessing the effect of chocolate consumption in subjects with a history of acne vulgaris Samantha Block, University of Miami Miller School of Medicine, Miami, FL, United States; Brian Berman, MD, PhD, Center for Clinical and Cosmetic Research, Aventura, FL, United States; Caroline Caperton, MD, University of Miami Miller School of Medicine, Miami, FL, United States; Martha Viera, MD, University of Miami Miller School of Medicine, Miami, FL, United States Background: To assess the effect of chocolate on acne exacerbation in males between the ages of 18 and 35 with a history of acne vulgaris in a double-blind placebo-controlled fashion. We hypothesized that chocolate will exacerbate acne in males with a history of acne vulgaris. Methods: Fourteen men between the ages of 18 and 35 will be assigned to swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the 2, at baseline. Lesions will be assessed and photographs will be taken at baseline, day 4, and day 7. Results: Thirteen of 14 subjects completed this IRB approved study. A statistically significant increase in the mean number of total acneiform lesions (comedones, papules, pustules, and nodules) was detected on both days 4 (P ¼ .006) and 7 (P ¼ .043) compared to baseline. A small-strength positive Pearson correlation coefficient existed between the amount of chocolate each subject consumed and the number of lesions each subject developed between baseline and day 4 (r ¼ 0.250), while a medium-strength positive correlation existed between baseline and day 7 (r ¼ 0.314). No serious adverse events occurred. Conclusion: It appears that in acne-prone, male individuals, the consumption of chocolate correlates to an increase in the exacerbation of acne. Commercial support: None identified.
AB14
J AM ACAD DERMATOL
Methods: The pooled analysis included data from 3 12-week, randomized, doubleblind, parallel group phase III studies. Acne severity according to the Evaluator’s Global Severity Score (EGSS) was mild, moderate, or severe (EGSS score of 2, 3, or 4, respectively). Treatment success was evaluated using % change in lesion counts and the dichotomised (D) GSS (%patients who were clear or almost clear or who had $ 2 grade improvement in EGSS). The proportion of patients who had a continuous reduction in lesion counts of $ 50% was estimated as an indicator of a clinically relevant response. Results: Clin-RA was significantly more effective than comparators at reducing inflammatory, noninflammatory, and total lesions in the overall population (4550 patients; P \.01), in the subgroup of 11- to 17-year-olds (2915 patients; P \.002), and in patients with mild/moderate acne (3662 patients; P \.02). In patients with severe acne (n ¼ 880), Clin-RA was significantly more effective than vehicle at reducing all lesion types (P \.0001) and than clindamycin at reducing inflammatory and total lesions (P # .048). The DGSS showed a significantly greater frequency of treatment success for Clin-RA versus clindamycin, tretinoin, and vehicle (32.1% vs 27.9%, 17.4%, and 9.9%; P # .001). Clin-RA was significantly faster than either monotherapy or vehicle in providing a $ 50% continuous reduction in inflammatory (P # .0028), noninflammatory (P # .0206), and total lesions (P # .0009). Clin-RA was well tolerated with scaling, erythema, itching, burning, and stinging being absent in the majority of patients. These events were mild to moderate in $ 95% patients in whom they occurred. Clin-RAetreated patients reported a slightly lower incidence of itching (4.3 vs 5.2%), burning (3.5 vs 3.7%), and stinging (1.7 vs 1.9%) versus tretinoin at week 12. Conclusion: Retinoid-based therapy is advocated by recent expert recommendations as first-line therapy for acne. Clin-RA is well tolerated and has superior efficacy to its component monotherapies and so should be considered as one of the first-line treatments of choice. 100% supported by Meda Pharma GmbH and Co KG.
APRIL 2013
P6707
Cross-study comparison of efficacy and safety of clindamycin 1%/tretinoin 0.025% and adapalene 0.1%/benzoyl peroxide 2.5% for acne vulgaris Montserrat Perez, MD, PhD, Clinica Dermatologica de Moragas, Barcelona, Spain
Efficacy and safety of a novel sonic brush head designed for cleansing acneic skin Emily Henes, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Katherine Ortblad, MBA, Pacific Bioscience Laboratories, Redmond, WA, United States; Lauri Tadlock, MD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Micheal Kearney, Pacific Bioscience Laboratories, Redmond, WA, United States; Nina Koski, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States; Robert Akridge, PhD, Pacific Bioscience Laboratories, Inc, Redmond, WA, United States
Background: Fixed-dose combination therapies, such as clindamycin 1%/tretinoin 0.025% (Clin-RA) and adapalene 0.1%/benzoyl peroxide 2.5% (Adap-BPO), are more effective than their constituent monotherapies for the treatment of acne vulgaris. Clin-RA is formulated using novel technology to combine clindamycin with solubilized and crystalline tretinoin in a patented alcohol-free, aqueous based gel. The unique formulation characteristics may account for the favorable cutaneous tolerability profile and low irritation potential of Clin-RA compared to other retinoidbased products. The aim of this post-hoc cross-study analysis was to compare the efficacy, safety, and tolerability of Clin-RA and Adap-BPO. Methods: Data for Clin-RA came from a metaanalysis of 3 phase III studies involving a total of 4550 patients (1853 were treated with Clin-RA). Adap-BPO data came from 3 large phase III studies of a total of 3855 patients (553 received Adap-BPO). All studies were 12-week, randomized, double-blind and parallel group in design. Results: Clin-RA and Adap-BPO were similarly effective at reducing inflammatory (median % change from baseline: 65.2% vs 62.8% Adap-BPO study 1, 62.1% AdapBPO study 2, and 70.3% Adap-BPO study 3) and noninflammatory acne lesions (51.6% vs 51.2%, 53.8%, and 62.2%). A lower proportion of Clin-RA treated pts experienced worsening of erythema (25.4% vs 40.7%), scaling (35.8% vs 45.8%), and stinging/burning events (17.9% vs 59.3%) versus patients treated with AdapBPO (data from studies 1 and 2). In addition, Clin-RA was associated with lower rates of the following versus Adap-BPO (studies 1 and 2): application site burning (0.3% vs 2.7%), dry skin/application site dryness (2.1% vs 7.4%), contact dermatitis/application site dermatitis (0.3% vs 3.2%), and pruritus/application site pruritus (0.4% vs 1.2%). Conclusion: Within the limitations of a cross-study comparison, these results show that the unique formulation of Clin-RA is associated with comparable efficacy to Adap-BPO and indicate that it has an improved safety and tolerability profile. This may translate into better patient compliance and Clin-RA being preferred by patients. 100% supported by Meda Pharma GmbH and Co. KG.
Background: Delicate compromised skin caused by specific skin conditions presents cleansing challenges. Removal of dirt, oil, and bacteria without harming the function of the skin barrier are important when cleansing the skin. The efficacy and safety of a new extra gentle sonic brush head (GBH) to cleanse delicate compromised skin associated with skin conditions (ie, acne) was evaluated. Methods: Efficacy was assessed in a 2-visit, split-forehead, randomized study (n ¼ 20) using a sebum capture methodology (Sebutape indicator strips; CuDerm, Dallas, TX) and image analysis to compare the GBH to a sensitive sonic brush head (SBH). Safety/gentleness was assessed in a second randomized study (n ¼ 10) using an exfoliation leg tanning methodology. Transepidermal water loss (TEWL), melanin (M), skin moisture/hydration (H), and erythema (E) were assessed before/after exaggerated use of 3 test products (sonic skin care brush using the normal brush head [NBH], a GBH, and a nylon facial cleansing pad [BP]), as well as a nontreatment control area. Duplicate measurements of M, H, and E and triplicate measurements of TEWL were taken before/after treatment. Results: To evaluate efficacy sebum levels remaining after cleansing were quantified by using image analysis software (Image J 1.43; NIH). Results were compared statistically using a paired t test. Residual sebum analysis found no statistically significant difference (P ¼ .71) between the GBH and SBH. Parametric statistical methods were used to evaluate the safety/gentleness. TEWL measurements after using each product fell within the normal range previously established for skin on the lower leg. The reduction of M (post-pre) was similar between the 3 treatments; all were significantly different from the nontreatment control (P ¼ .01). A nonclinically significant change in E was observed after the treatment with the GBH; no significant differences in change from baseline were detected as compared to the untreated control with either brush head. Conclusion: Analysis confirmed the GBH is safe/gentle for daily use to cleanse delicate compromised skin associated with skin conditions (ie, acne). 100% is sponsored by Pacific Bioscience Laboratories.
P6404 Efficacy and safety of novel clindamycin 1%/tretinoin 0.025% formulation for acne vulgaris: Pooled analysis of 3 phase III studies Vincenzo Bettoli, MD, Department of Clinical and Experimental Medicine, Section of Dermatology, Azienda Ospedaliera Universitaria Arcispedale S. Anna, University of Ferrara, Ferrara, Italy Background: The foundation of therapy for most patients with acne is a topical retinoid because they reduce the formation of microcomedones. Combination therapies include an antimicrobial agent to provide synergy and optimise lesion clearance. The aim of this pooled analysis was to compare the efficacy and safety of a novel clindamycin 1%/tretinoin 0.025% (Clin-RA) gel formulation versus its constituent monotherapies and vehicle for the treatment of acne.
P6935 Double-blind, placebo-controlled study assessing the effect of chocolate consumption in subjects with a history of acne vulgaris Samantha Block, University of Miami Miller School of Medicine, Miami, FL, United States; Brian Berman, MD, PhD, Center for Clinical and Cosmetic Research, Aventura, FL, United States; Caroline Caperton, MD, University of Miami Miller School of Medicine, Miami, FL, United States; Martha Viera, MD, University of Miami Miller School of Medicine, Miami, FL, United States Background: To assess the effect of chocolate on acne exacerbation in males between the ages of 18 and 35 with a history of acne vulgaris in a double-blind placebo-controlled fashion. We hypothesized that chocolate will exacerbate acne in males with a history of acne vulgaris. Methods: Fourteen men between the ages of 18 and 35 will be assigned to swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the 2, at baseline. Lesions will be assessed and photographs will be taken at baseline, day 4, and day 7. Results: Thirteen of 14 subjects completed this IRB approved study. A statistically significant increase in the mean number of total acneiform lesions (comedones, papules, pustules, and nodules) was detected on both days 4 (P ¼ .006) and 7 (P ¼ .043) compared to baseline. A small-strength positive Pearson correlation coefficient existed between the amount of chocolate each subject consumed and the number of lesions each subject developed between baseline and day 4 (r ¼ 0.250), while a medium-strength positive correlation existed between baseline and day 7 (r ¼ 0.314). No serious adverse events occurred. Conclusion: It appears that in acne-prone, male individuals, the consumption of chocolate correlates to an increase in the exacerbation of acne. Commercial support: None identified.
AB14
J AM ACAD DERMATOL
Methods: The pooled analysis included data from 3 12-week, randomized, doubleblind, parallel group phase III studies. Acne severity according to the Evaluator’s Global Severity Score (EGSS) was mild, moderate, or severe (EGSS score of 2, 3, or 4, respectively). Treatment success was evaluated using % change in lesion counts and the dichotomised (D) GSS (%patients who were clear or almost clear or who had $ 2 grade improvement in EGSS). The proportion of patients who had a continuous reduction in lesion counts of $ 50% was estimated as an indicator of a clinically relevant response. Results: Clin-RA was significantly more effective than comparators at reducing inflammatory, noninflammatory, and total lesions in the overall population (4550 patients; P \.01), in the subgroup of 11- to 17-year-olds (2915 patients; P \.002), and in patients with mild/moderate acne (3662 patients; P \.02). In patients with severe acne (n ¼ 880), Clin-RA was significantly more effective than vehicle at reducing all lesion types (P \.0001) and than clindamycin at reducing inflammatory and total lesions (P # .048). The DGSS showed a significantly greater frequency of treatment success for Clin-RA versus clindamycin, tretinoin, and vehicle (32.1% vs 27.9%, 17.4%, and 9.9%; P # .001). Clin-RA was significantly faster than either monotherapy or vehicle in providing a $ 50% continuous reduction in inflammatory (P # .0028), noninflammatory (P # .0206), and total lesions (P # .0009). Clin-RA was well tolerated with scaling, erythema, itching, burning, and stinging being absent in the majority of patients. These events were mild to moderate in $ 95% patients in whom they occurred. Clin-RAetreated patients reported a slightly lower incidence of itching (4.3 vs 5.2%), burning (3.5 vs 3.7%), and stinging (1.7 vs 1.9%) versus tretinoin at week 12. Conclusion: Retinoid-based therapy is advocated by recent expert recommendations as first-line therapy for acne. Clin-RA is well tolerated and has superior efficacy to its component monotherapies and so should be considered as one of the first-line treatments of choice. 100% supported by Meda Pharma GmbH and Co KG.
APRIL 2013