Controlled Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

Condition(s) targeted: Cutaneous Leishmaniasis

Intervention: WR 279,396 topical cream (Drug); Paromomycin topical cream (Drug); Topical cream placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

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

Official(s) and/or principal investigator(s):
Afif Ben Salah, M.D., Ph.D., Principal Investigator, Affiliation: Institute Pasteur Tunisia

Overall contact:
Afif Ben Salah, M.D., Ph.D., Phone: 216-71-792-429, Email: afif.bensalah@pasteur.rns.tn

This study will test the ability of the topical cream WR 279,396 to treat the skin lesions or "Baghdad boil" caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin. This cream will be compared to the effect of a topical cream containing paromomycin alone and to a placebo cream that contains no antibiotics. Therefore, this study will have three groups of patients, and they will be assigned to one of these treatments randomly. The study will be carried out without the patient or the physician knowing which cream is being used for which patient. The goal is to determine if WR 279,396 cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than paromomycin alone.

Official title: A Pivotal, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: WR 279,396 is superior to placebo in lesion healing

Secondary outcome: Paromomycin topical cream is superior to placebo in lesion healing

Detailed description: This is an efficacy study to test the ability of WR 279,396 topical cream to treat non-serious, non-complicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and children in Tunisia where the disease in endemic. A total of 315 volunteers will be randomized to the three arms described above to determine product efficacy. Safety data in all three arms will also be collected.

Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Presence of cutaneous leishmaniasis diagnosed by culture or staining techniques on

lesion aspirates or smear from scraping on the index lesion

- Five or fewer cutaneous lesions

- Each lesion between 1 and 5 cm in greatest diameter

- volunteer willing to forego other forms of treatment for CL

Exclusion Criteria:

- Received previous treatment for CL within the last 6 months

- Have difficulty complying with instructions

- Have only one lesion that is not primarily ulcerative or in an area that is difficult

to treat

- Have a lesion that involves the mucosa

- Have signs or symptoms of disseminated disease

- Be a female with a positive pregnancy test

- have active malignancy or history of malignancy except squamous cell carcinoma of the

skin that has been removed

- Significant organ abnormality or chronic disease that in the opinion of the

investigator would warrant exclusion of the participant from the study or prevent the participant from completing the study

- Receiving any medication with pentavalent antimony or any other therapy for cutaneous

leishmaniasis except for mercurichrome

- Participant or parent/guardian unable to understand verbal and/or written Arabic,

English or French in which a certified translation of the informed consent is available

- Any immuno-compromising condition including recidivant leishmaniasis (during the past

two years) or diabetes

- History of known or suspected idiosyncratic reactions or hypersensitivity to

aminoglycosides

Afif Ben Salah, M.D., Ph.D., Phone: 216-71-792-429, Email: afif.bensalah@pasteur.rns.tn

Central Clinic, Sidi Bouzid, Tunisia; Recruiting
Afif Ben Salah, M.D., Ph.D., Phone: 216-71-792-429, Email: afif.bensalah@pasteur.rtn.tn
Afif Ben Salah, M.D., Ph.D., Principal Investigator

Starting date: January 2008
Ending date: December 2010
Last updated: June 20, 2008