Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application
NCT ID: NCT00490230
Last Updated: 2016-01-01
Study Results
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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COMPLETED
NA
108 participants
INTERVENTIONAL
2007-04-30
2007-06-30
Brief Summary
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Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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WR 279,396
CL lesions treated with WR 279396
WR 279396
Natural Healing
CL lesions healed naturally
No interventions assigned to this group
vehicle control
CL lesions were treated with the vehicle alone
WR 279396
Interventions
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WR 279396
Eligibility Criteria
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Inclusion Criteria
* 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
5 Years
75 Years
ALL
Yes
Sponsors
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Institut Pasteur
INDUSTRY
U.S. Army Medical Research and Development Command
FED
Responsible Party
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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
Countries
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Other Identifiers
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WRAIR 1303
Identifier Type: -
Identifier Source: org_study_id
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