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Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leishmaniasis, Cutaneous

Intervention: WR 279,396 (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
Timothy Whitman, DO, USN, Principal Investigator, Affiliation: Walter Reed Army Medical Center

Summary

The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).

Clinical Details

Official title: An Open-Label Clinical Study to Examine the Safety, Efficacy, and Pharmacokinetics of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis at Walter Reed National Military Medical Center (WRNMMC)

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of adverse events

Number of initial clinical cures

Number of initial clinical improvements

Number of no relapses of index lesion between nominal Day 60 and nominal Day 100

Secondary outcome:

Number of cures of all other lesions

Area of ulceration of the index lesion

Area of ulceration of all treated lesions

Number of ulcerated lesion complete cure rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must be male or female military health care beneficiary of any race or

ethnicity and at least 18 years of age

- Subjects must give written informed consent.

- Subjects must 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; 3) positive polymerase chain reaction (PCR) assay; and/or 4) prior diagnosis of CL within 14 days of the start of treatment.

- Subjects must have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the

criteria for an index lesion (Larger lesions will be accepted for treatment, but these will not be included in the primary evaluation of efficacy).

- Subjects must be willing to forego other forms of treatments for CL including other

investigational treatment during the study.

- Subjects must be capable of understanding and complying with the protocol (in the

opinion of the investigator).

- Subjects must expect to be located in the Washington DC metropolitan area for at

least the duration of the screening, 20-day treatment period, and Day 28 +/- 2 days follow-up visit.

- Subjects who are female and of child-bearing potential, must have a negative

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.

- Subject has adequate venous access for blood draws, if consented to the PK part of

study. Exclusion Criteria:

- Subject has had a prior diagnosis of leishmaniasis where all lesions had healed.

- Subject has 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.

- Subject has a lesion due to Leishmania that involves the mucosa or palate.

- Subject has signs and symptoms of disseminated disease.

- Subject is a female who is breast-feeding.

- Subject has 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.

- Subject has significant organ abnormality, chronic disease such as diabetes, severe

hearing loss, evidence of renal or hepatic dysfunction, or creatinine, AST, or ALT greater than the upper limit of normal as defined by the clinical laboratory normal ranges.

- Subject has received treatment for leishmaniasis including thermosurgery (ThermoMed™)

or 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) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; or allopurinol within 4 weeks of starting study treatment.

- Subject has a history of known or suspected hypersensitivity or idiosyncratic

reactions to aminoglycosides.

- Subject has any other topical disease/condition which interferes with the objectives

of this study.

Locations and Contacts

Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland 20889, United States
Additional Information

Starting date: July 2010
Last updated: June 4, 2015

Page last updated: August 23, 2015

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