1. 1 Clinical Studies Section of Labeling Joseph Porres, M.D., Ph.D. Medical Officer Division of Dermatologic and Dental Drug Products FDA

2. 2 Clinical Studies Section of Labeling Efficacy Endpoints: The following endpoints have been used to evaluate efficacy in Phase 3 trials for acne: §Acne lesions: l total lesion count l inflammatory lesion count l non-inflammatory lesion count §Investigator Global Evaluation (IGE): assessment of the condition of acne at the predefined evaluation point

3. 3 Clinical Studies Section of Labeling § pivotal trials § duration of the studies § number of patients who received drug treatment and the number who received placebo (or vehicle) § mean age at enrollment. § statistically significant difference § types of patients included, or excluded: severity, gender, pregnancy, age

4. 4 Clinical Studies Section of Labeling “Drug product P was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. A total of 295 patients received P and 296 received placebo. Mean age at enrollment for both groups was 24 years. At six cycles each study demonstrated a statistically significant difference between P and placebo for mean change from baseline in lesion counts (see Table T and Figure F). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied.”

5. 5 Clinical Studies Section of Labeling

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8. 8 “Drug Product users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.” Studies where baseline counts differ for each study.

9. 9 Clinical Studies Section of Labeling

10. 10 Clinical Studies Section of Labeling In summary: §Presenting information as text, tables, and figures offers prescribers a comprehensive summary of the efficacy data observed in Phase 3 trials. §The three formats complement each other since each one is helpful in conveying a particular aspect of the data.