Trial · NCT00703924

Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

NCT00703924, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2017-02-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World. Trials, record NCT00703924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00703924

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
NCT number: NCT00703924
Status: Completed
Phases: Phase 2
Enrollment: 92 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Cutaneous Leishmaniasis
Interventions: WR 279,396, Placebo
First posted: 2008-06-24
Last updated: 2017-05-30
Results first posted: 2017-02-15

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	180 days	CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups
Primary	Safety of WR 279,396 (AEs and SAEs)	180 days	Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.
Secondary	Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse	180 days	100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.
Secondary	Final Cure Rate by Subject of All Lesions	180 days	Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.
Secondary	Rate of Relapse	180 days	Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.

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	Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	180 days		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety of WR 279,396 (AEs and SAEs)	180 days	All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.	Adverse Events	NUMBER
SECONDARY	Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse	180 days	Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Final Cure Rate by Subject of All Lesions	180 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Relapse	180 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	WR 279,396	CCR	47	Participants
Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	Placebo	CCR	30	Participants
Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	WR 279,396	CCR Failure	3	Participants
Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)	Placebo	CCR Failure	12	Participants
Safety of WR 279,396 (AEs and SAEs)	WR 279,396	Solicated AEs- Mild	49	Adverse Events
Safety of WR 279,396 (AEs and SAEs)	Placebo	Solicated AEs- Mild	40	Adverse Events
Safety of WR 279,396 (AEs and SAEs)	WR 279,396	Solicited AEs- Moderate	11	Adverse Events
Safety of WR 279,396 (AEs and SAEs)	Placebo	Solicited AEs- Moderate	5	Adverse Events
Safety of WR 279,396 (AEs and SAEs)	WR 279,396	Solicited AEs- Severe	2	Adverse Events
Safety of WR 279,396 (AEs and SAEs)	Placebo	Solicited AEs- Severe	2	Adverse Events

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	WR 279,396	50
Overall Study	STARTED	Placebo	42
Overall Study	COMPLETED	WR 279,396	49
Overall Study	COMPLETED	Placebo	41
Overall Study	NOT COMPLETED	WR 279,396	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events104

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	Immediate - Local pain	General disorders	WR 279,396	7	50	7
other	Immediate - Local pain	General disorders	Placebo	6	42	6
other	Immediate - Local pain	General disorders	WR 279,396	0	50	0
other	Immediate - Local pain	General disorders	Placebo	0	42	0
other	Immediate - Local pain	General disorders	WR 279,396	0	50	0
other	Immediate - Local pain	General disorders	Placebo	0	42	0
other	Immediate - Local Erythema	Skin and subcutaneous tissue disorders	WR 279,396	15	50	15
other	Immediate - Local Erythema	Skin and subcutaneous tissue disorders	Placebo	10	42	10
other	Immediate - Local Erythema	Skin and subcutaneous tissue disorders	WR 279,396	5	50	5
other	Immediate - Local Erythema	Skin and subcutaneous tissue disorders	Placebo	2	42	2

1 to 10 of 104Source ClinicalTrials.gov

See all 104 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	WR 279,396
Total, all-cause mortality	Placebo
Total, other adverse events	WR 279,396	16	50
Total, other adverse events	Placebo	12	42
Total, serious adverse events	WR 279,396	1	50
Total, serious adverse events	Placebo	0	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19415122	RESULT

Source PubMed

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
WR 279,396 vs Placebo: Rate of Relapse	Trial comparisons
WR 279,396 vs Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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