Clinical Trials Logo

Clinical Trial Summary

This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin. 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.


Clinical Trial Description

This is an efficacy study to test the ability of WR 279,396 topical cream to treat uncomplicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and children in Tunisia where the disease in endemic. A total of 375 volunteers will be randomized to the three arms described above to determine product efficacy. Safety data in all three arms will also be collected. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00606580
Study type Interventional
Source U.S. Army Medical Research and Materiel Command
Contact
Status Completed
Phase Phase 3
Start date January 2008
Completion date July 2011

See also
  Status Clinical Trial Phase
Completed NCT01988909 - WR 279,396 for the Treatment of Cutaneous Leishmaniasis Phase 2
Enrolling by invitation NCT00840359 - Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis Phase 2
Enrolling by invitation NCT00737386 - Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank N/A
Completed NCT00233545 - Miltefosine to Treat Cutaneous Leishmaniasis in Bolivia Phase 2
Completed NCT01462500 - Pharmacokinetics of Miltefosine in Children and Adults Phase 4
Completed NCT01011309 - A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis Phase 2
Completed NCT01301924 - Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis Phase 2/Phase 3
Not yet recruiting NCT02281669 - Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients N/A
Completed NCT01464242 - Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis Phase 2/Phase 3
Completed NCT01790659 - Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama Phase 3
Completed NCT01050907 - Miltefosine to Treat Mucocutaneous Leishmaniasis Phase 2
Completed NCT04340128 - Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Phase 3
Terminated NCT00317629 - Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Phase 3
Completed NCT00351520 - Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica Phase 3
Completed NCT01381055 - Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis Phase 2/Phase 3
Completed NCT01050777 - Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis Phase 0
Completed NCT01380314 - Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis Phase 2
Terminated NCT01380301 - Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony Phase 2
Completed NCT00703924 - Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World Phase 2
Completed NCT00344084 - Surveillance for Leishmaniasis Skin Lesions in Mali