Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama

NCT01790659 | Completed Phase 3 Results DMC

• 1 other identifier: S-12-21
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396 results in statistically superior final clinical cure rates of an index lesion when compared with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L panamensis.

Conditions

Cutaneous Leishmaniasis

Keywords

leishmaniasis; cutaneous leishmaniasis; Leishmania panamensis; L panamensis; Paromomycin; Paromomycin/Gentamicin

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Final Clinical Cure

  The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows: * Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, * Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, * Subject has no relapse of index lesion.

  baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days

Secondary Outcomes (5)

• Percentage of Subjects With All Lesions Cured

  100 ± 14 days

• Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)

  Day 168

• Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point

  baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days

• Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point

  baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days

• Median Time to Initial Clinical Cure for Index Lesions

  When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days

Study Arms (2)

WR 279,396

EXPERIMENTAL

(Paromomycin and Gentamicin Topical Cream)

Drug: WR 279,396

Paromomycin

EXPERIMENTAL

Paromomycin alone

Drug: Paromomycin

Interventions

WR 279,396 DRUG

WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%

Also known as: Paromomycin/Gentamicin topical cream

WR 279,396

Paromomycin DRUG

Paromomycin alone

Paromomycin

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 2 years-of-age
• Subject or legal guardian able to give written informed consent or assent, as appropriate
• Diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes or 2) microscopic identification of amastigotes in stained lesion tissue
• At least one ulcerative lesion ≥ 1 cm and ≤ 5 cm that has a diagnosis of CL
• Willing to forego other forms of treatments for CL including other investigational treatments during the study
• In the opinion of the investigator, subject (or their legal guardian), subject is capable of understanding and complying with the protocol
• If female and of child-bearing potential, must have a negative serum pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 week after treatment is completed

You may not qualify if:

• Lesion due to leishmania that involves the nasal or oral mucosa or any signs of mucosal disease that might be due to Leishmania
• Only a single lesion on the ear with erosive cartilage
• Signs and symptoms of disseminated disease in the opinion of the investigator
• More than 10 lesions
• Female who is breast-feeding
• Significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than 15% above the upper limit of normal (ULN) as defined by the clinical laboratory defined normal ranges
• Received treatment for leishmaniasis including any medication with pentavalent antimony including sodium stibogluconate (Pentostam™), meglumine antimoniate (Glucantime™); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed within 56 days of starting study treatments
• History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides

Sponsors & Collaborators

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

Study Sites (1)

Instituto Conmemorativo Gorgas de Estudios de la Salud,

Panama City, Panama

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Nestor Sosa, MD, FACP
• Organization: Instituto Conmemorativo Gorgas de Estudios de la Salud

drnsosa@gmail.com

507-527-4950

Study Officials

• Nestor Sosa, MD, FACP

  Instituto Conmemorativo Gorgas de Estudios de la Salud

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 13, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 14, 2018
• Results First Posted: August 23, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)