A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
This study has been completed.
Sponsor:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01536795
First received: February 16, 2012
Last updated: March 15, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Old World Cutaneous Leishmaniasis |
Drug: WR279 396 with Tegaderm Dressing Drug: WR 279, 396 with Gauze and Tape Dressing |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by U.S. Army Medical Research and Materiel Command:
Primary Outcome Measures:
- Change from baseline tolerance will be evaluated by local adverse reactions and by laboratory signs of systemic events. [ Time Frame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 50, 90 ] [ Designated as safety issue: Yes ]Forty 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).
Secondary Outcome Measures:
- Efficacy [ Time Frame: Day 50, 90 ] [ Designated as safety issue: No ]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.
| Enrollment: | 40 |
| Study Start Date: | October 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: WR279396 with Tegaderm dressing
24 patients will be randomly allocated to WR279396 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 WR279396 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT01536795 History of Changes |
| Other Study ID Numbers: | A-9768.2, IND50,098 |
| Study First Received: | February 16, 2012 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by U.S. Army Medical Research and Materiel Command:
|
Ointment to treat leishmania skin lesions |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Cutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Gentamicins Paromomycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Amebicides Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 19, 2013