NCT01988909

WR 279,396 for the Treatment of Cutaneous Leishmaniasis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	WR 279,396	Paromomycin + Gentamicin Topical Cream

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-11-20
• Last updated: 2017-01-25

Locations

2 sites across 1 country: France