Clinical trial NCT00490230: Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Leishmaniasis
Scar
Keywords: Paromomycin
Gentamicin
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: Institut Pasteur
First posted: 2007-06-22
Enrollment: 108
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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)

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 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

Primary outcomes:
measure: Cosmetic outcome based on modified Vancouver Scar Score (mVSS)
timeFrame: Day 360 or greater
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Institute Pasteur de Tunis
Study officials:
affiliation: Walter Reed Army Institute of Research (WRAIR)
name: COL Doug Walsh, MD
role: PRINCIPAL_INVESTIGATOR
References: