Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application (SCAR)

United States Army Medical Research and Development Command (USAMRDC)

Status: Completed

Conditions: Cutaneous Leishmaniasis; Scar

Treatments: Drug: WR 279396

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00490230

WRAIR 1303

Details and patient eligibility

About

Primary Objectives:

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

Full 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

Enrollment: 108 patients

Sex: All

Ages: 5 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

108 participants in 3 patient groups, including a placebo group

WR 279,396

Experimental group

Description:

CL lesions treated with WR 279396

Treatment:

Drug: WR 279396

Natural Healing

No Intervention group

Description:

CL lesions healed naturally

vehicle control

Placebo Comparator group

Description:

CL lesions were treated with the vehicle alone

Treatment:

Drug: WR 279396