WR 279,396 for the Treatment of Cutaneous Leishmaniasis

NCT01988909 | Completed Phase 2

• 1 other identifier: P080705
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin \& gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous leishmaniasis; Paromomycin + Gentamicin Topical Cream; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• final clinical cure rate for the index lesion: initial clinical cure

  Initial clinical cure: 100% reepithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed \>50% reepithelialization by Day 100

  Day 42 or day 100

Secondary Outcomes (1)

• final clinical cure rate for the index lesion: Relapse

  day 42 or day 100

Study Arms (1)

WR 279,396

EXPERIMENTAL

All patients with the same Study drug: WR 279,396 (Topical Paromomycin and Gentamicin Cream)

Drug: WR 279,396

Interventions

WR 279,396 DRUG

Paromomycin + Gentamicin Topical Cream

WR 279,396

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, patients must:
• Be male or females ages 2 to 80 years of age, inclusive.
• Have non-complicated, non-severe CL.
• Be able to give written informed consent or by their legal representative.
• Have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue and/or 3) by positive polymerase chain reaction (PCR). Patients who have a prior diagnosis of CL within 30 days of the start of treatment are eligible without a confirmatory test during screening.
• Have at least one ulcerative lesion ≥ 1 cm and \< 5 cm, that meets the criteria for an index lesion.
• Be willing to forego other forms of treatments for CL including other investigational treatment during the study.
• In the opinion of the investigator, be capable of understanding (or their legal representative) and complying with the protocol.
• Expect to be located in the area of the clinical site for at least the duration of the screening, 20-day treatment period, and for the followup visits at Days 28 +/- 2 days, 42 +/- 7 days and 100 +/- 14 days.
• If female and of child-bearing potential, have a negative serum or urine pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 month after treatment is completed.

You may not qualify if:

• Also, to be eligible for the study, patients must not:
• Have a prior diagnosis of leishmaniasis where all lesions had healed.
• Have only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion \<1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drug topically.
• Have a lesion due to leishmania that involves the mucosa or palate.
• Have signs and symptoms of disseminated disease.
• Be a female who is breast-feeding.
• Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
• Have significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, myasthenia gravis, parkinsonism, impairment of the eighth cranial nerve or clinically significant levels of creatinine, AST, or ALT in the judgment of the investigator.
• Have received treatment for leishmaniasis (except mercurochrome or local antiseptics) including any medication with pentavalent antimony including sodium stibogluconate (Pentostam), meglumine antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); WR 279,396; or other medications containing paromomycin (administered parenterally or topically) within 56 days of starting study treatments, or methylbenzethonium chloride (MBCL); or local or systemic antibiotics of the following families (penicillin, betalactamics, cyclines, synergistin, macrolides, lincosamides, fusidic acid, mupirocin) within 8 days of starting study treatments.
• Have history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
• Have any other topical disease/condition which would interfere with the objectives of this study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Centre d'investigations cliniques- Hopital Robert Debré

Paris, 75019, France

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

Study Officials

• Pierre Buffet, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

FR (2)