Old World Cutaneous Leishmaniasis Clinical Trial
Official title:
Topical Treatment of Old World Cutaneous Leishmaniasis With WR279396 (Paromomycin/Gentamicin Ointment): Efficacy and Tolerance of a Regimen Using an Occlusive Polyurethane Dressing
Verified date | February 2021 |
Source | U.S. Army Medical Research and Development Command |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment. Extensive objective and subjective local tolerance data will also be captured during this trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the deep dermis) that may help to determine the optimal number and duration of treatments. The results from this study will help determine the most practical treatment schedule and will answer questions that are crucial to improve the present treatment regimen with WR279396 which is twice a day for 20 days.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: The study population will be selected from adults (18y) patients and children above 15y in Tunisia (Old World) - Age: 15 - 75 years old - Lesion character: each diameter (horizontal and vertical) of the lesion test must measure 7 mm, the lesion must be primarily ulcerative (i.e., not verrucous or nodular) and located in a biopsy friendly site of the body - Parasitological diagnosis: have cutaneous leishmaniasis proven parasitologically in lesion selected for inclusion in study (lesion test). - Informed consent: have given written informed consent to participate in the study: (i.e. patient or legal representative). Exclusion Criteria: - Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient or immediate family members. - Previous use of antileishmanial drugs (within 2 months) or present use of routinely nephrotoxic or ototoxic drugs. - Potential for follow up: Have less than 4 months time remaining in present address and/or plans to leave the area for more than 30 days. - Extent of disease: More than 10 lesions or lesion ³ 5 cm or a lesion less than 2 cm from eye, in the ear, or a lesion in the face, that in the opinion of the attending dermatologist could potentially cause significant disfigurement. - Location of disease: mucosal involvement. - Disseminated disease: clinically significant lymphadenitis with nodules that are painful and > 1 cm in size in the lymphatic drainage of the ulcer. - Concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies: - Kidney: clinically significant abnormalities of urine analysis, serum levels of Creatinine, BUN, total proteins > upper limit of normal for the laboratory. - Liver: AST or ALT > upper limit of normal for the laboratory. - General: glucose, Na, K, > upper limit of normal or < lower limit of normal for the laboratory. Volunteers in whom these normal laboratory values are exceeded by less than 25% will not be automatically excluded. These volunteers will be evaluated on the basis of history, physical, as well as laboratory values. - Scheduled or ongoing pregnancy as determined clinical and biological criteria. - Presence of signs or symptoms of peripheral neuropathy, myasthenia gravis or neuromuscular block |
Country | Name | City | State |
---|---|---|---|
Tunisia | Institut Pasteur | Tunis |
Lead Sponsor | Collaborator |
---|---|
U.S. Army Medical Research and Development Command |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Area of the Index Lesion's Ulceration by Study Day | Area of the index lesion's ulceration over time in mm2 | Days 1, 10, 20, 50 and 90 | |
Other | Area of the Index Lesion's Induration by Study Day | Area of the index lesion's induration over time in mm2 | Days 1, 10, 20, 50 and 90 | |
Other | Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90 | Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90 | Days 10, 20, 50 and 90 | |
Primary | Safety: Overview of Adverse Events | Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions | During 20 day treatment period | |
Secondary | Clinical Responses of Index Lesions (100% Re-epithelialization) | Efficacy will be evaluated in terms of the number of lesions cured at D50 (D1 is the first day of treatment) with no relapse by Day 90. Complete clinical respoonse is defined as 100% re-epithelialization of the index lesion by Day 50 or a > 50% re-epithelialization by Day 50 followed by complete re-epithelialization on or before Day 90, with no relapse ever having occurred from Day 50 through Day 90. | Day 50, 90 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04268524 -
Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
|
Phase 3 |