Cutaneous Leishmaniasis Clinical Trial
Official title:
An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France
The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).
Patients with suspected CL will be screened up to a 14 day period for eligibility including
parasitology for confirmation of ulcerative CL. Recruitment will primarily be from patients
exposed to leishmaniasis. A target enrollment of 30 patients will receive WR 279,396 (15%
paromomycin + 0.5% gentamicin topical cream) once daily for 20 days.
The index lesion and all other ulcerated lesions will be assessed for clinical response by
measurement of the length and width of area of ulceration. A lesion will be considered to be
completely cured if 100% re-epithelialization is observed. Non-ulcerated lesions will also
be measured to monitor the total area of exposure of lesions to study drug and will be
evaluated for cure.
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