Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

NCT ID: NCT00490230

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-06-30

Brief Summary

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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

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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

Conditions

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Cutaneous Leishmaniasis Scar

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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WR 279,396

CL lesions treated with WR 279396

Group Type EXPERIMENTAL

WR 279396

Intervention Type DRUG

Natural Healing

CL lesions healed naturally

Group Type NO_INTERVENTION

No interventions assigned to this group

vehicle control

CL lesions were treated with the vehicle alone

Group Type PLACEBO_COMPARATOR

WR 279396

Intervention Type DRUG

Interventions

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WR 279396

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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COL Doug Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Locations

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Institute Pasteur de Tunis

Tunis, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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WRAIR 1303

Identifier Type: -

Identifier Source: org_study_id

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