Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application (SCAR)

This study has been completed.
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00490230
First received: June 20, 2007
Last updated: July 11, 2014
Last verified: July 2014

June 20, 2007
July 11, 2014
April 2007
June 2007   (final data collection date for primary outcome measure)
Cosmetic outcome based on modified Vancouver Scar Score (mVSS) [ Time Frame: Day 360 or greater ] [ Designated as safety issue: No ]
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).
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Complete list of historical versions of study NCT00490230 on ClinicalTrials.gov Archive Site
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Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application
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)

Primary Objectives:

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

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
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Cutaneous Leishmaniasis
  • Scar
Drug: WR 279396
  • Experimental: WR 279,396
    CL lesions treated with WR 279396
    Intervention: Drug: WR 279396
  • No Intervention: Natural Healing
    CL lesions healed naturally
  • Placebo Comparator: vehicle control
    CL lesions were treated with the vehicle alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
5 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Tunisia
 
NCT00490230
WRAIR 1303
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Institut Pasteur
Principal Investigator: COL Doug Walsh, MD Walter Reed Army Institute of Research (WRAIR)
U.S. Army Medical Research and Materiel Command
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP