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Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
This study has been completed.
Sponsor:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00606580
First received: January 21, 2008
Last updated: June 11, 2014
Last verified: June 2014
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Results First Received: May 12, 2014
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition: |
Cutaneous Leishmaniasis |
| Interventions: |
Drug: WR 279,396 topical cream Drug: Paromomycin Alone topical cream Drug: Vehicle placebo cream |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Reporting Groups
| Description | |
|---|---|
| WR 279,396 Topical Treament |
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream) WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing. |
| Paromomycin Alone Topical Treatment |
Paromomycin Alone topical cream (15% paromomycin topical cream) Paromomycin Alone 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. |
| Vehicle Placebo Cream |
The cream base without the addition of paromomycin or gentamicin Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing. |
Participant Flow: Overall Study
| WR 279,396 Topical Treament | Paromomycin Alone Topical Treatment | Vehicle Placebo Cream | |
|---|---|---|---|
| STARTED | 125 | 125 | 125 |
| COMPLETED | 123 | 122 | 103 |
| NOT COMPLETED | 2 | 3 | 22 |
| Lost to Follow-up | 1 | 1 | 4 |
| Clinical failures | 1 | 0 | 12 |
| Withdrawal by investigator | 0 | 1 | 6 |
| Withdrawal by Subject | 0 | 1 | 0 |
Show Baseline Characteristics
Outcome Measures
| 1. Primary: | Final Clinical Cure Rate [ Time Frame: Day 42, 98, and 168 ] |
| 2. Secondary: | Final Clinical Cure Rate (Per Protocol Dataset) [ Time Frame: Day 42, 98, and 168 ] |
| 3. Secondary: | Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse [ Time Frame: Day 42 ] |
| 4. Secondary: | Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up [ Time Frame: Days 42, 49, and 98 ] |
| 5. Secondary: | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42 [ Time Frame: Days 42 ] |
| 6. Secondary: | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49 [ Time Frame: Days 49 ] |
| 7. Secondary: | Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98 [ Time Frame: Days 98 ] |
| 8. Secondary: | Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion [ Time Frame: Day 42 ] |
| 9. Secondary: | Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse [ Time Frame: Day 168 ] |
| 10. Secondary: | Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse [ Time Frame: Day 168 ] |
| 11. Secondary: | Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42 [ Time Frame: Day 42 ] |
| 12. Secondary: | Number of Subjects With a Relapse on or After Day 42 [ Time Frame: Day 168 ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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More Information
Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Results Point of Contact:
Name/Title: Division of Regulated Activies and Compliance
Organization: US Army Medical Materiel Development Activity (USAMMDA)
phone: 301-619-0317
e-mail: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil
Organization: US Army Medical Materiel Development Activity (USAMMDA)
phone: 301-619-0317
e-mail: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT00606580 History of Changes |
| Other Study ID Numbers: |
A-14134 |
| Study First Received: | January 21, 2008 |
| Results First Received: | May 12, 2014 |
| Last Updated: | June 11, 2014 |