Trial · NCT01536795
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
NCT01536795, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2021-01-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis. Trials, record NCT01536795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01536795
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
- NCT number
- NCT01536795
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Old World Cutaneous Leishmaniasis
- Interventions
- WR279,396 with Tegaderm Dressing, WR 279,396 with Gauze and Tape Dressing
- First posted
- 2012-02-22
- Last updated
- 2021-02-12
- Results first posted
- 2021-01-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Overview of Adverse Events | During 20 day treatment period | Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions |
| Secondary | Clinical Responses of Index Lesions (100% Re-epithelialization) | Day 50, 90 | Efficacy will be evaluated in terms of the number of lesions cured at D50 (D1 is the first day of treatment) with no relapse by Day 90. Complete clinical respoonse is defined as 100% re-epithelialization of the index lesion by Day 50 or a \> 50% re-epithelialization by Day 50 followed by complete re-epithelialization on or before Day 90, with no relapse ever having occurred from Day 50 through Day 90. |
| Other | Area of the Index Lesion's Ulceration by Study Day | Days 1, 10, 20, 50 and 90 | Area of the index lesion's ulceration over time in mm2 |
| Other | Area of the Index Lesion's Induration by Study Day | Days 1, 10, 20, 50 and 90 | Area of the index lesion's induration over time in mm2 |
| Other | Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90 | Days 10, 20, 50 and 90 | Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90 |
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 | Safety: Overview of Adverse Events | During 20 day treatment period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Responses of Index Lesions (100% Re-epithelialization) | Day 50, 90 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Area of the Index Lesion's Ulceration by Study Day | Days 1, 10, 20, 50 and 90 | mm^2 | MEAN | |
| OTHER_PRE_SPECIFIED | Area of the Index Lesion's Induration by Study Day | Days 1, 10, 20, 50 and 90 | On D50 in the Gauze-Tape group no SD was given in the data table. All good cause efforts to locate the data for Day 50 SD value for gauze and tape dressing arm have been exhausted, data are missing and hence not available to be reported. | mm^2 | MEAN |
| OTHER_PRE_SPECIFIED | Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90 | Days 10, 20, 50 and 90 | % change in induration | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Overview of Adverse Events | WR279,396 With Tegaderm Dressing | Subjects with atleast 1 AE | 16 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Gauze and Tape Dressing | Subjects with atleast 1 AE | 7 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Tegaderm Dressing | Subjects with an SAE | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Gauze and Tape Dressing | Subjects with an SAE | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Tegaderm Dressing | Withdrawals due to an AE | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Gauze and Tape Dressing | Withdrawals due to an AE | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Tegaderm Dressing | Not due to an AE | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Gauze and Tape Dressing | Not due to an AE | 1 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Tegaderm Dressing | Deaths | 0 | Participants | |
| Safety: Overview of Adverse Events | WR279,396 With Gauze and Tape Dressing | Deaths | 0 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | WR279,396 With Tegaderm Dressing | 24 | |
| Overall Study | STARTED | WR279,396 With Gauze and Tape Dressing | 24 | |
| Overall Study | COMPLETED | WR279,396 With Tegaderm Dressing | 23 | |
| Overall Study | COMPLETED | WR279,396 With Gauze and Tape Dressing | 22 | |
| Overall Study | NOT COMPLETED | WR279,396 With Tegaderm Dressing | 1 | |
| Overall Study | NOT COMPLETED | WR279,396 With Gauze and Tape Dressing | 2 |
Source ClinicalTrials.gov
Adverse events24
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 | Vertigo | Ear and labyrinth disorders | WR279,396 With Tegaderm Dressing | 2 | 24 | 2 |
| other | Vertigo | Ear and labyrinth disorders | WR279,396 With Gauze and Tape Dressing | 0 | 24 | 0 |
| other | Local reaction (infection at biopsy site) | General disorders | WR279,396 With Tegaderm Dressing | 1 | 24 | 1 |
| other | Local reaction (infection at biopsy site) | General disorders | WR279,396 With Gauze and Tape Dressing | 0 | 24 | 0 |
| other | Edema | General disorders | WR279,396 With Tegaderm Dressing | 1 | 24 | 1 |
| other | Edema | General disorders | WR279,396 With Gauze and Tape Dressing | 5 | 24 | 5 |
| other | Pain | General disorders | WR279,396 With Tegaderm Dressing | 1 | 24 | 1 |
| other | Pain | General disorders | WR279,396 With Gauze and Tape Dressing | 4 | 24 | 4 |
| other | Pyrexia | General disorders | WR279,396 With Tegaderm Dressing | 0 | 24 | 0 |
| other | Pyrexia | General disorders | WR279,396 With Gauze and Tape Dressing | 1 | 24 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | WR279,396 With Tegaderm Dressing | 0 | 24 |
| Total, all-cause mortality | WR279,396 With Gauze and Tape Dressing | 0 | 24 |
| Total, other adverse events | WR279,396 With Tegaderm Dressing | 16 | 24 |
| Total, other adverse events | WR279,396 With Gauze and Tape Dressing | 7 | 24 |
| Total, serious adverse events | WR279,396 With Tegaderm Dressing | 0 | 24 |
| Total, serious adverse events | WR279,396 With Gauze and Tape Dressing | 0 | 24 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| WR279,396 With Tegaderm Dressing vs WR279,396 With Gauze and Tape Dressing: deaths from any cause | Trial comparisons |
| WR279,396 With Tegaderm Dressing vs WR279,396 With Gauze and Tape Dressing: serious adverse events | Trial comparisons |
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/NCT01536795
GET https://conductscience.org/api/trials/v1/NCT01536795/results?page=2