Rapamycin Dose-Ranging Efficacy Study: A Phase II, proof of concept, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the effects of different strengths of rapamycin cream applied topically in subjects diagnosed with port wine stains

Subjects diagnosed with port wine stains

The primary efficacy endpoint is the change in extent and intensity of PWS colour from baseline to week 12 (V3), or at last visit if early withdrawal/discontinuation occurs, measured using a colorimetry system through standardized clinical photographs.

Change in extent and intensity of PWS colour from baseline at weeks 0, 4, 8 and follow-up/last assessment, measured using a colorimetry system through standardized clinical photographs., Subjective improvement rating of PWS from baseline after 0, 4, 8 and 12 weeks of treatment, Clinic Objective improvement rating in PWS from baseline after 0, 4, 8 and 12 weeks of treatment, Photographic Objective improvement rating in PWS from baseline after 0, 4, 8 and 12 weeks of treatment

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