Clinical Trial: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

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

Official Title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

Brief Summary: This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

Detailed Summary: WR 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. The goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. Subjects will be randomized to receive either WR 279,396 or vehicle placebo; applied twice a day for 20 days.
Sponsor: U.S. Army Medical Research and Materiel Command

Current Primary Outcome:

• Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) [ Time Frame: 180 days ]
  CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test.
• Efficacy and Safety of WR 279,396 (AEs and SAEs) [ Time Frame: 180 days ]
  Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.

Original Primary Outcome: Re-epithelialization of lesion [ Time Frame: 50 days ]

Current Secondary Outcome:

• Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse [ Time Frame: 180 days ]
  100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.
• Final Cure Rate by Subject of All Lesions [ Time Frame: 180 days ]
  Final cure rate by subject was determined using the Fisher's exact test
• Rate of Relapse [ Time Frame: 180 days ]
  Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180

Original Secondary Outcome: Safety and tolerance of the cream [ Time Frame: 50 days ]

Information By: U.S. Army Medical Research and Materiel Command

Dates:
Date Received: June 20, 2008
Date Started: March 2003
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016