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
  Purpose

Primary Objectives:

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


Condition Intervention
Cutaneous Leishmaniasis
Scar
Drug: WR 279396

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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).


Enrollment: 108
Study Start Date: April 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WR 279,396
CL lesions treated with WR 279396
Drug: WR 279396
No Intervention: Natural Healing
CL lesions healed naturally
Placebo Comparator: vehicle control
CL lesions were treated with the vehicle alone

Detailed 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
  Eligibility

Ages Eligible for Study:   5 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490230

Locations
Tunisia
Institute Pasteur de Tunis
Tunis, Tunisia, 1002
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Institut Pasteur
Investigators
Principal Investigator: COL Doug Walsh, MD Walter Reed Army Institute of Research (WRAIR)
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00490230     History of Changes
Other Study ID Numbers: WRAIR 1303
Study First Received: June 20, 2007
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Paromomycin
Gentamicin

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014