Journal of Clinical and Aesthetic Dermatology

JUN 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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38 JCAD journal of clinical and aesthetic dermatology June 2017 • Volume 10 • Number 6 P O S t P H O C A N A L Y S I S lesion counts) were conducted independently of patient assessment (SSA). All missing efficacy data were imputed using the last observation carried forward (LOCF). Least squares means (LSMean), standard deviations, and treatment p- values for the Hispanic population were obtained from an analysis of covariance with factors of treatment and respective baseline lesion count as a covariate. Values were adjusted for multiple imputation. Data were compared to that seen in the non- Hispanic population where LSMean data were provided from an analysis of covariance with factors of treatment, ethnicity, and treatment by ethnicity interaction, and the respective baseline lesion counts as a covariate. Median data represent average values, obtained from averaging the summary statistics generated from each imputed dataset. P-values for treatment success (EGSS) were obtained from a logistic regression with factor of treatment group. Values were adjusted for multiple imputation. Differences in patient-reported outcomes were assessed using a Cochran-Mantel-Haenszel general association test, stratified by analysis center. Statistical significance was based on 2-tailed tests of the null hypothesis resulting in P-values of 0.05 or less. All AEs occurring during the study were recorded and classified on the basis of medical dictionary for drug regulatory activities terminology for the safety population (MedDRA dictionary). Difference between treatment groups were assessed from Fisher's exact test. Descriptive statistics were used to summarize cutaneous safety and tolerability scores at baseline, Weeks 2, 4, 8, and 12. RESULTS Overall, 125 Hispanic patients (91.9%) completed the study, including 60 (93.8%) patients treated with clindamycin phosphate 1.2%/BP 3.75% gel and 65 (90.3%) patients treated with vehicle. Only four patients treated with clindamycin phosphate 1.2%/BP 3.75% gel withdrew from the study. Reasons for study discontinuation were lost to follow-up (N=1) and withdrawal by subject (N=3). Patients treated with vehicle (N=7) withdrew for the same reasons. There were no study withdrawals due to AEs (Figure 1). Demographic data were not significantly different across the two treatment groups. The mean age (standard deviation, SD) was 20.5 (6.43) years, and there were slightly more female patients (54.4% vs. 45.6% male patients) (Table 1). There was no significant difference between the two treatment groups in terms of baseline lesion counts or EGSS. At baseline, the mean (SD) number of inflammatory and noninflammatory lesions was 26.2 (4.91) and 32.3 (14.29), respectively. Overall, the majority of patients (89.0%) had moderate acne (an EGSS of 3). There was a slightly higher proportion of severe acne Fi g u re 1 . S t u d y d i s p o s i t i o n ( al l ran d o m i ze d Hi s p an i c s u b j e ct s )

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