Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

NCT00490230 | Completed

• 1 other identifier: WRAIR 1303
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cutaneous Leishmaniasis; Scar

Keywords

Paromomycin; Gentamicin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

WR 279,396

EXPERIMENTAL

CL lesions treated with WR 279396

Drug: WR 279396

Natural Healing

NO INTERVENTION

CL lesions healed naturally

vehicle control

PLACEBO COMPARATOR

CL lesions were treated with the vehicle alone

Drug: WR 279396

Interventions

WR 279396 DRUG

WR 279,396; vehicle control

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• Potential volunteers without a prior documented diagnosis of CL

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Institut Pasteur: collaborator

Study Sites (1)

Institute Pasteur de Tunis

Tunis, 1002, Tunisia

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Cicatrix

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• COL Doug Walsh, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

TU (1)