Clinical Trial: WR 279,396 for the Treatment of Cutaneous Leishmaniasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: final clinical cure rate for the index lesion: initial clinical cure [ Time Frame: Day 42 or day 100 ]

Initial clinical cure: 100% reepithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed >50% reepithelialization by Day 100


Original Primary Outcome: Same as current

Current Secondary Outcome: final clinical cure rate for the index lesion: Relapse [ Time Frame: day 42 or day 100 ]

Relapse is defined as a 10 percent or greater increase in the area of ulceration of the index lesion or a shift from 100% to < 100% re-epithelialization of the index lesion at nominal Day 100 for those patients that had 100% re-epithelialization of the index lesion at nominal Day 42 or before


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: November 14, 2013
Date Started: September 2013
Date Completion:
Last Updated: January 24, 2017
Last Verified: January 2017