Trial · NCT01494350
WR 279,396 Open Label Treatment Protocol in Tunisia
NCT01494350, Phase 2, Terminated, U.S. Army Medical Research and Development Command; results first posted 2014-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. WR 279,396 Open Label Treatment Protocol in Tunisia. Trials, record NCT01494350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- WR 279,396 Open Label Treatment Protocol in Tunisia
- NCT number
- NCT01494350
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Cutaneous Leishmaniasis
- Interventions
- WR 279,396 topical cream
- First posted
- 2011-12-19
- Last updated
- 2014-12-19
- Results first posted
- 2014-12-19
- Limitations and caveats
This study was closed prematurely due study team and travel restrictions but not due to any safety issues with the study subjects. Only a total of 50 of the 110 planned subjects were enrolled in the study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Clinical Cure Rate for the Index Lesion | Final clincial cure is measured at day 98 | Number of index lesions with 100% reepithelialization at Day 98. |
| Secondary | Area of Index Lesions Throughout the Study | Measured at day 0, 20, 28, 42, and 98 | Area (mm\^2) of index lesion on Days 0, 20, 28, 42, and 98. |
| Secondary | Number of Index Lesions With Reepithelialization Throughout the Study | Measured at day 28 and 42 | Number of index lesions with 100% reepithelialization on Days 28 and 42. |
| Secondary | Area of All Ulcerated Lesions Throughout the Study | Measured at day 20, 28, 42 and 98 | Area of all ulcerated lesions on Days 20, 28, 42, and 98. |
| Secondary | Number of All Ulcerated Lesions With Reepithelialization on Day 28 | Measured on day 28 | Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Final Clinical Cure Rate for the Index Lesion | Final clincial cure is measured at day 98 | modified intent to treat (mITT) | lesions | NUMBER |
| SECONDARY | Area of Index Lesions Throughout the Study | Measured at day 0, 20, 28, 42, and 98 | modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18. | mm^2 | MEAN |
| SECONDARY | Number of Index Lesions With Reepithelialization Throughout the Study | Measured at day 28 and 42 | modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18. | lesions | NUMBER |
| SECONDARY | Area of All Ulcerated Lesions Throughout the Study | Measured at day 20, 28, 42 and 98 | modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18. | mm^2 | MEAN |
| SECONDARY | Number of All Ulcerated Lesions With Reepithelialization on Day 28 | Measured on day 28 | modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18. | lesions | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Final Clinical Cure Rate for the Index Lesion | WR 279,396 Topical Cream | 48 | lesions | ||
| Area of Index Lesions Throughout the Study | WR 279,396 Topical Cream | Baseline (Day 0) | 121 | Standard Deviation 106 | mm^2 |
| Area of Index Lesions Throughout the Study | WR 279,396 Topical Cream | Day 20 | 393 | Standard Deviation 315 | mm^2 |
| Area of Index Lesions Throughout the Study | WR 279,396 Topical Cream | Day 28 | 203 | Standard Deviation 238 | mm^2 |
| Area of Index Lesions Throughout the Study | WR 279,396 Topical Cream | Day 42 | 38.9 | Standard Deviation 83.2 | mm^2 |
| Area of Index Lesions Throughout the Study | WR 279,396 Topical Cream | Day 98 | 7.88 | Standard Deviation 55.1 | mm^2 |
| Number of Index Lesions With Reepithelialization Throughout the Study | WR 279,396 Topical Cream | Day 28 | 8 | lesions | |
| Number of Index Lesions With Reepithelialization Throughout the Study | WR 279,396 Topical Cream | Day 42 | 28 | lesions | |
| Area of All Ulcerated Lesions Throughout the Study | WR 279,396 Topical Cream | Baseline (Day 0) | 82.6 | Standard Deviation 90.4 | mm^2 |
| Area of All Ulcerated Lesions Throughout the Study | WR 279,396 Topical Cream | Day 20 | 288 | Standard Deviation 275 | mm^2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | WR 279,396 Topical Cream | 50 | |
| Overall Study | COMPLETED | WR 279,396 Topical Cream | 49 | |
| Overall Study | NOT COMPLETED | WR 279,396 Topical Cream | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Application site erythema | General disorders | WR 279,396 Topical Cream | 12 | 50 | |
| other | Application site vesicles | General disorders | WR 279,396 Topical Cream | 27 | 50 | |
| other | Oedema | General disorders | WR 279,396 Topical Cream | 1 | 50 | |
| other | Pain | General disorders | WR 279,396 Topical Cream | 1 | 50 | |
| other | Bronchitis acute | Infections and infestations | WR 279,396 Topical Cream | 2 | 50 | |
| other | Superinfection | General disorders | WR 279,396 Topical Cream | 1 | 50 | |
| other | Scratch | Injury, poisoning and procedural complications | WR 279,396 Topical Cream | 1 | 50 | |
| other | Thermal burn | Injury, poisoning and procedural complications | WR 279,396 Topical Cream | 1 | 50 | |
| other | Alanine aminotrasnsferase increased | Investigations | WR 279,396 Topical Cream | 1 | 50 | |
| other | Blood urea increased | Investigations | WR 279,396 Topical Cream | 1 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | WR 279,396 Topical Cream | ||
| Total, other adverse events | WR 279,396 Topical Cream | 39 | 50 |
| Total, serious adverse events | WR 279,396 Topical Cream | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01494350
GET https://conductscience.org/api/trials/v1/NCT01494350/registered