A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT01536795|
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : January 7, 2021
Last Update Posted : February 12, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Old World Cutaneous Leishmaniasis||Drug: WR279,396 with Tegaderm Dressing Drug: WR 279,396 with Gauze and Tape Dressing||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
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
Drug: WR279,396 with Tegaderm Dressing
Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
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).
Drug: WR 279,396 with Gauze and Tape Dressing
Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
- Safety: Overview of Adverse Events [ Time Frame: During 20 day treatment period ]Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions
- Clinical Responses of Index Lesions (100% Re-epithelialization) [ Time Frame: Day 50, 90 ]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.
- Area of the Index Lesion's Ulceration by Study Day [ Time Frame: Days 1, 10, 20, 50 and 90 ]Area of the index lesion's ulceration over time in mm2
- Area of the Index Lesion's Induration by Study Day [ Time Frame: Days 1, 10, 20, 50 and 90 ]Area of the index lesion's induration over time in mm2
- Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90 [ Time Frame: Days 10, 20, 50 and 90 ]Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536795
|Principal Investigator:||Afif Ben Salah,, MD, PhD||Institut Pasteur, Tunisia|