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Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application (SCAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00490230
Recruitment Status : Completed
First Posted : June 22, 2007
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

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)


Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Scar Drug: WR 279396 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2007
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: WR 279396



Primary Outcome Measures :
  1. Cosmetic outcome based on modified Vancouver Scar Score (mVSS) [ Time Frame: Day 360 or greater ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490230


Locations
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Tunisia
Institute Pasteur de Tunis
Tunis, Tunisia, 1002
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
Institut Pasteur
Investigators
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Principal Investigator: COL Doug Walsh, MD Walter Reed Army Institute of Research (WRAIR)
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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00490230    
Other Study ID Numbers: WRAIR 1303
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by U.S. Army Medical Research and Development Command:
Paromomycin
Gentamicin
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases