Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

Scar Clinical Trial

— SCAR  

Official title:

Assessment of Cutaneous Leishmaniasis Scar (Caused by Leishmania Major) for Cosmetic Outcome After Treatment With WR279396 (Paromomycin/Gentamicin Cream in Vehicle) Versus a No Treatment Control Group (Natural Healing)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490230
• Other study ID #: WRAIR 1303
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: December 31, 2015
• Start date: April 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2015
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objectives:

Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)

Description:

Secondary Objectives

1. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing)

2. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396

• To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing)

• To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 75 Years

Eligibility

Inclusion Criteria:

• Included are volunteers who participated in WRAIR 813 (HSRRB Log # 9768.1) and those who participated in another CL study in/around the WRAIR 813 study site who had been assigned to a "no-treatment" (natural healing) arm. All volunteers will have had documented CL in the past that were treated with WR279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old.

• For study subjects who were enrolled in WRAIR 813 in 2004 (WR279396 or vehicle treated):

• Written informed consent obtained from the subject or guardian

• Willing to meet the requirements of the single clinic visit

• Prior data in the clinical site data base documenting a diagnosis of CL

• Each lesion for inclusion in this study conforms to WRAIR 813: ³ 1 cm in diameter and was primarily ulcerative (i.e., not verrucous or nodular)

• The index lesion and others to be scored were proven parasitologically by Giemsa slide smear

• CL scars documented to be > 360 days old (clock starts at time of diagnosis)

• No treatment of the lesions other than that received in the previous protocol

• Study subjects from the earlier studies to serve as "no treatment" controls:

• Written informed consent obtained from the subject or guardian

• Willing to meet the requirements of the single clinic visit

• Same age range as WRAIR 813: 5-75 years old at time of diagnosis

• Prior data in the clinical site data base documenting a diagnosis of CL, and that the volunteer was assigned to the "no treatment" group

• Each lesion for inclusion in this study will conform to WRAIR 813: at the time of diagnosis, =1 cm in diameter and described as primarily ulcerative (i.e., not verrucous or nodular)

• At least 1 lesion that was proven parasitologically by Giemsa slide smear for inclusion in the earlier study.

• CL scars documented to be > 360 days old (clock starts at time of diagnosis)

• Never received any treatment of the lesions (natural healing) or applied any medication, such as herbal medication

• Lesions present on the trunk or extremities, to match the WRAIR 813 study volunteers (no facial lesions were treated in the 2004 study)

Exclusion Criteria:

• Potential volunteers without a prior documented diagnosis of CL

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous
• Scar

Intervention

Drug:
• WR 279396

Locations

Country	Name	City	State
Tunisia	Institute Pasteur de Tunis	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	Institut Pasteur

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic outcome based on modified Vancouver Scar Score (mVSS)	The primary cosmetic outcome measure is the Clinical Scar Rating, based on a modified Vancouver Scar Score (mVSS). The primary efficacy endpoint is the percent of persons judged to have either a "superior (no scar)" or "excellent" rating (see below).	Day 360 or greater	No