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Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous Leishmaniasis; Scar

Intervention: WR 279396 (Drug)

Phase: N/A

Status: Completed

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
COL Doug Walsh, MD, Principal Investigator, Affiliation: Walter Reed Army Institute of Research (WRAIR)

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Cosmetic outcome based on modified Vancouver Scar Score (mVSS)

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

Minimum age: 5 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Institute Pasteur de Tunis, Tunis 1002, Tunisia
Additional Information

Starting date: April 2007
Last updated: July 11, 2014

Page last updated: August 23, 2015

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