Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application (SCAR)

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)

Study Overview

• Status: Completed
• Conditions: Scar; Cutaneous Leishmaniasis
• Intervention / Treatment: Drug: WR 279396

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

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1002
    • Institute Pasteur de Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic outcome based on modified Vancouver Scar Score (mVSS)	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).	Day 360 or greater

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: Institut Pasteur
• Investigators: Principal Investigator: COL Doug Walsh, MD, Walter Reed Army Institute of Research (WRAIR)

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: June 20, 2007
• First Submitted That Met QC Criteria: June 21, 2007
• First Posted (Estimate): June 22, 2007

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Paromomycin; Gentamicin
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous
• Other Study ID Numbers: WRAIR 1303