- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536795
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
Topical Treatment of Old World Cutaneous Leishmaniasis With WR279396 (Paromomycin/Gentamicin Ointment): Efficacy and Tolerance of a Regimen Using an Occlusive Polyurethane Dressing
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty-eight patients (48) with Old World cutaneous leishmaniasis will be randomly allocated to WR279396 treatment once a day for 20 days with an optimized polyurethane dressing (occlusion) (24 patients), or without occlusion (24 patients). All patients will be rescued with the standard of care accepted in Tunisia, if the patient is not cured. The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC).
Each subject will be followed for clinical cure for 90 days after the initiation of treatment. Cure is defined as 100% reepithelialization without relapse by 3 months.
Tolerance will be evaluated by local adverse reactions and by laboratory signs of systemic events.
In addition to the clinical evaluation of the CL lesions, the following parameters/clinical healing surrogates will be investigated:
- parasite load will be determined in superficial and deep lesional dermis samples at D0 and D10. The mean parasite reduction ratio (parasite load at D10/parasite load at D0) in each group will be compared;
- aminoglycoside concentrations in superficial and deep infiltrated dermis in each group will be compared.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Tunis, Tunisia
- Institut Pasteur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WR279,396 with Tegaderm dressing
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
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Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
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Experimental: WR279,396 with Gauze and Tape Dressing
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
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Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Overview of Adverse Events
Time Frame: During 20 day treatment period
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Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions
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During 20 day treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Time Frame: Day 50, 90
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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.
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Day 50, 90
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area of the Index Lesion's Ulceration by Study Day
Time Frame: Days 1, 10, 20, 50 and 90
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Area of the index lesion's ulceration over time in mm2
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Days 1, 10, 20, 50 and 90
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Area of the Index Lesion's Induration by Study Day
Time Frame: Days 1, 10, 20, 50 and 90
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Area of the index lesion's induration over time in mm2
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Days 1, 10, 20, 50 and 90
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Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90
Time Frame: Days 10, 20, 50 and 90
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Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90
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Days 10, 20, 50 and 90
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Collaborators and Investigators
Investigators
- Principal Investigator: Afif Ben Salah,, MD, PhD, Institut Pasteur, Tunisia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-9768.2
- IND50,098 (Other Identifier: US FDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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