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

Sponsors and Collaborators:	U.S. Army Medical Research and Materiel Command Walter Reed Army Institute of Research (WRAIR)
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00606580

Purpose

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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: WR 279,396 topical cream Drug: Paromomycin topical cream Drug: Topical cream placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pivotal, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Leishmaniasis

Drug Information available for: Paromomycin sulfate Paromomycin

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

WR 279,396 is superior to placebo in lesion healing [ Time Frame: 48 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Paromomycin topical cream is superior to placebo in lesion healing [ Time Frame: 48 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	315
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 105 subjects will be randomized to this arm to receive WR 279,396 topical cream	Drug: WR 279,396 topical cream WR 279,396 is a topical antibiotic cream containing 15% paromomycin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
2: Experimental Subjects in this arm will receive the same topical cream containing 15% paromomycin alone	Drug: Paromomycin topical cream The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
3: Placebo Comparator This arm consists of a vehicle placebo, namely, the topical cream used in the other two arms. In this case, the antibiotics have been removed. The placebo will also be applied daily to cutaneous leishmaniasis lesions daily and covered with a protective, sterile gauze dressing.	Drug: Topical cream placebo Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.

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.

Eligibility

Ages Eligible for Study:	5 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606580

Contacts

Contact: Afif Ben Salah, M.D., Ph.D.	216-71-792-429	afif.bensalah@pasteur.rns.tn
Contact: Nathalie Messaoud, M.D.	216-71-792-429	nathalie. messaoud@pasteur.rns.tn

Locations

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

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Afif Ben Salah, M.D., Ph.D.

Institute Pasteur Tunisia

More Information

No publications provided

Responsible Party:	Division of Regulated Activities and Compliance, USAMMDA, USAMRMC ( Robert E. Miller, Ph.D., RAC, Director, )
Study ID Numbers:	A-14134
Study First Received:	January 21, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00606580 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:

cutaneous leishmaniasis, topical treatment, Tunisia

Study placed in the following topic categories:

Leishmaniasis
Anti-Infective Agents
Anti-Bacterial Agents
Protozoan Infections
Skin Diseases, Infectious

Skin Diseases
Parasitic Diseases
Leishmaniasis, Cutaneous
Paromomycin

Additional relevant MeSH terms:

Leishmaniasis
Anti-Infective Agents
Protozoan Infections
Antiprotozoal Agents
Skin Diseases, Parasitic
Skin Diseases
Mastigophora Infections
Leishmaniasis, Cutaneous
Pharmacologic Actions

Paromomycin
Anti-Bacterial Agents
Skin Diseases, Infectious
Antiparasitic Agents
Therapeutic Uses
Sarcomastigophora Infections
Parasitic Diseases
Amebicides

ClinicalTrials.gov processed this record on September 03, 2009