Trial · NCT00606580

Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)

NCT00606580, Phase 3, Completed, U.S. Army Medical Research and Development Command; results first posted 2014-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia). Trials, record NCT00606580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00606580

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Trial

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

Title: Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
NCT number: NCT00606580
Status: Completed
Phases: Phase 3
Enrollment: 375 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Cutaneous Leishmaniasis
Interventions: WR 279,396 topical cream, Paromomycin Alone topical cream, Vehicle placebo cream
First posted: 2008-02-04
Last updated: 2014-07-14
Results first posted: 2014-07-14

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Final Clinical Cure Rate	Day 42, 98, and 168	Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows: * Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation. * Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98. * Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168. * Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse.
Secondary	Final Clinical Cure Rate (Per Protocol Dataset)	Day 42, 98, and 168	Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.
Secondary	Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse	Day 42	For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.
Secondary	Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up	Days 42, 49, and 98
Secondary	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42	Days 42
Secondary	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49	Days 49
Secondary	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98	Days 98
Secondary	Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion	Day 42
Secondary	Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse	Day 168	Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42
Secondary	Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse	Day 168	Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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	Day 42, 98, and 168	Modified intention-to-treat (mITT) - all subjects randomized who received at least one treatment of study drug.	participants	NUMBER
SECONDARY	Final Clinical Cure Rate (Per Protocol Dataset)	Day 42, 98, and 168	Per protocol - all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.	participants	NUMBER
SECONDARY	Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse	Day 42	mITT dataset	percentage of participants	NUMBER
SECONDARY	Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up	Days 42, 49, and 98	mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.	percentage of participants	NUMBER
SECONDARY	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42	Days 42	mITT dataset	Percentage of lesions	NUMBER
SECONDARY	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49	Days 49	mITT dataset	percentage of lesions	NUMBER
SECONDARY	Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98	Days 98	mITT dataset	percentage of lesions	NUMBER
SECONDARY	Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion	Day 42		participants	NUMBER
SECONDARY	Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse	Day 168	mITT population	participants	NUMBER
SECONDARY	Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse	Day 168	mITT dataset	participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group42

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	WR 279,396 Topical Treament		101		participants
Final Clinical Cure Rate	Paromomycin Alone Topical Treatment		102		participants
Final Clinical Cure Rate	Vehicle Placebo Cream		73		participants
Final Clinical Cure Rate (Per Protocol Dataset)	WR 279,396 Topical Treament		101		participants
Final Clinical Cure Rate (Per Protocol Dataset)	Paromomycin Alone Topical Treatment		102		participants
Final Clinical Cure Rate (Per Protocol Dataset)	Vehicle Placebo Cream		73		participants
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse	WR 279,396 Topical Treament		67.2	95% Confidence Interval 58.5 to 74.8	percentage of participants
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse	Paromomycin Alone Topical Treatment		68.8	95% Confidence Interval 60.2 to 76.3	percentage of participants
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse	Vehicle Placebo Cream		48.8	95% Confidence Interval 40.2 to 57.5	percentage of participants
Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up	WR 279,396 Topical Treament	Day 42	67.2	95% Confidence Interval 59.5 to 76.0	percentage of participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	WR 279,396 Topical Treament	125
Overall Study	STARTED	Paromomycin Alone Topical Treatment	125
Overall Study	STARTED	Vehicle Placebo Cream	125
Overall Study	COMPLETED	WR 279,396 Topical Treament	123
Overall Study	COMPLETED	Paromomycin Alone Topical Treatment	122
Overall Study	COMPLETED	Vehicle Placebo Cream	103
Overall Study	NOT COMPLETED	WR 279,396 Topical Treament	2
Overall Study	NOT COMPLETED	Paromomycin Alone Topical Treatment	3
Overall Study	NOT COMPLETED	Vehicle Placebo Cream	22

Source ClinicalTrials.gov

Adverse events96

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
other	Anaemia	Blood and lymphatic system disorders	WR 279,396 Topical Treament	1	125
other	Anaemia	Blood and lymphatic system disorders	Paromomycin Alone Topical Treatment	0	125
other	Anaemia	Blood and lymphatic system disorders	Vehicle Placebo Cream	0	125
other	Lymphadenitis	Blood and lymphatic system disorders	WR 279,396 Topical Treament	1	125
other	Lymphadenitis	Blood and lymphatic system disorders	Paromomycin Alone Topical Treatment	0	125
other	Lymphadenitis	Blood and lymphatic system disorders	Vehicle Placebo Cream	0	125
other	Food poisoning	Gastrointestinal disorders	WR 279,396 Topical Treament	1	125
other	Food poisoning	Gastrointestinal disorders	Paromomycin Alone Topical Treatment	0	125
other	Food poisoning	Gastrointestinal disorders	Vehicle Placebo Cream	0	125
other	Application site bleeding	General disorders	WR 279,396 Topical Treament	1	125

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	WR 279,396 Topical Treament
Total, all-cause mortality	Paromomycin Alone Topical Treatment
Total, all-cause mortality	Vehicle Placebo Cream
Total, other adverse events	WR 279,396 Topical Treament	55	125
Total, other adverse events	Paromomycin Alone Topical Treatment	51	125
Total, other adverse events	Vehicle Placebo Cream	45	125
Total, serious adverse events	WR 279,396 Topical Treament	0	125
Total, serious adverse events	Paromomycin Alone Topical Treatment	0	125
Total, serious adverse events	Vehicle Placebo Cream	0	125

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23388004	DERIVED

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 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.

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.

GET https://conductscience.org/api/trials/v1/NCT00606580

GET https://conductscience.org/api/trials/v1/NCT00606580/results?page=2

API reference For AI assistants