Primary Objectives: Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
Secondary Objectives 1. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing) 2. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396 * To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing) * To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
108
Institute Pasteur de Tunis
Tunis, Tunisia
Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
The primary cosmetic outcome measure is the Clinical Scar Rating, based on a modified Vancouver Scar Score (mVSS). The primary efficacy endpoint is the percent of persons judged to have either a "superior (no scar)" or "excellent" rating (see below).
Time frame: Day 360 or greater
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