A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis

NCT01536795 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: A-9768.2IND50,098
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Old World Cutaneous Leishmaniasis

Keywords

Ointment to treat leishmania skin lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Responses of Index Lesions (100% Re-epithelialization)

  Day 50, 90

Other Outcomes (3)

• Area of the Index Lesion's Ulceration by Study Day

  Days 1, 10, 20, 50 and 90

• Area of the Index Lesion's Induration by Study Day

  Days 1, 10, 20, 50 and 90

• Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90

  Days 10, 20, 50 and 90

Study Arms (2)

WR279,396 with Tegaderm dressing

EXPERIMENTAL

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

WR279,396 with Gauze and Tape Dressing

EXPERIMENTAL

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

Interventions

WR279,396 with Tegaderm Dressing DRUG

Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing

WR279,396 with Tegaderm dressing

WR 279,396 with Gauze and Tape Dressing DRUG

Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days

WR279,396 with Gauze and Tape Dressing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed consent: have given written informed consent to participate in the study: (i.e. patient or legal representative).

You may not qualify if:

• 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

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Institut Pasteur

Tunis, Tunisia

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Afif Ben Salah, MD
• Organization: Institut Pasteur, Tunisia

afif.bensalah@pateur.rns.tn

011-216-71-792-429

Study Officials

• Afif Ben Salah,, MD, PhD

  Institut Pasteur, Tunisia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: October 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: February 12, 2021
• Results First Posted: January 7, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)