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 ]
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 ]
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