Trial · NCT01790659

Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama

NCT01790659, Phase 3, Completed, U.S. Army Medical Research and Development Command; results first posted 2017-08-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama. Trials, record NCT01790659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01790659

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Trial

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

Title: Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
NCT number: NCT01790659
Status: Completed
Phases: Phase 3
Enrollment: 399 participants, actual
Lead sponsor: U.S. Army Medical Research and Development Command
Conditions: Cutaneous Leishmaniasis
Interventions: WR 279,396, Paromomycin
First posted: 2013-02-13
Last updated: 2018-02-14
Results first posted: 2017-08-23

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Percent of Participants With Final Clinical Cure	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows: * Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, * Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, * Subject has no relapse of index lesion.
Secondary	Percentage of Subjects With All Lesions Cured	100 ± 14 days	• Percentage of subjects with all lesions cured, defined as: Final clinical cure as defined in primary objective (which is based solely on the index lesion); AND, Cure of all other lesions by nominal Day 100 (100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions)
Secondary	Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)	Day 168	Percentage of all lesions meeting criteria for clinical cure during the study at 168 day mark for mITT subjects
Secondary	Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	Area of ulceration (mm\^2) of the index lesion at each measurement time point for mITT subjects
Secondary	Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	Area of ulceration (mm\^2) of all treated lesions from baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days for mITT subjects. Data presented is as presented in the Final Clinical Study Report; any inconsistencies can't be changed.
Secondary	Median Time to Initial Clinical Cure for Index Lesions	When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	Median time to initial clinical cure for index lesions (100% re-epithelialization of the index lesion)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Participants With Final Clinical Cure	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	MITT subjects	percent of participants	NUMBER
SECONDARY	Percentage of Subjects With All Lesions Cured	100 ± 14 days	MITT subjects	percentage of participants	NUMBER
SECONDARY	Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)	Day 168	Cure rates of all lesions over time without regard to subject for mITT subjects	percentage of lesions	NUMBER
SECONDARY	Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	mITT subjects	mm^2	MEAN
SECONDARY	Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point	baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	All lesions for mITT Subjects	mm^2	MEAN
SECONDARY	Median Time to Initial Clinical Cure for Index Lesions	When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days	MITT subjects	Days	MEDIAN

Source ClinicalTrials.gov

Results by group60

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

Outcome	Group	Category	Value	Spread	Units
Percent of Participants With Final Clinical Cure	WR 279,396		78.6		percent of participants
Percent of Participants With Final Clinical Cure	Paromomycin		77.8		percent of participants
Percentage of Subjects With All Lesions Cured	WR 279,396		75.1		percentage of participants
Percentage of Subjects With All Lesions Cured	Paromomycin		76.3		percentage of participants
Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)	WR 279,396		77.2		percentage of lesions
Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)	Paromomycin		83.3		percentage of lesions
Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	WR 279,396	Day 1	153	Standard Deviation 137	mm^2
Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	Paromomycin	Day 1	165	Standard Deviation 167	mm^2
Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	WR 279,396	Day 20	831	Standard Deviation 627	mm^2
Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point	Paromomycin	Day 20	928	Standard Deviation 986	mm^2

1 to 10 of 60Source ClinicalTrials.gov

See all 60 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	201
Overall Study	STARTED	Paromomycin	198
Overall Study	COMPLETED	WR 279,396	195
Overall Study	COMPLETED	Paromomycin	192
Overall Study	NOT COMPLETED	WR 279,396	6
Overall Study	NOT COMPLETED	Paromomycin	6

Source ClinicalTrials.gov

Adverse events94

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	Lymphadenitis	Blood and lymphatic system disorders	WR 279,396	6	201	6
other	Lymphadenitis	Blood and lymphatic system disorders	Paromomycin	6	198	6
other	Lymphadenopathy	Blood and lymphatic system disorders	WR 279,396	6	201	6
other	Lymphadenopathy	Blood and lymphatic system disorders	Paromomycin	10	198	10
other	Abdominal pain (upper)	Gastrointestinal disorders	WR 279,396	5	201	5
other	Abdominal pain (upper)	Gastrointestinal disorders	Paromomycin	3	198	3
other	Diarrhoea	Gastrointestinal disorders	WR 279,396	8	201	8
other	Diarrhoea	Gastrointestinal disorders	Paromomycin	4	198	4
other	Gastritis	Gastrointestinal disorders	WR 279,396	6	201	6
other	Gastritis	Gastrointestinal disorders	Paromomycin	0	198	0

1 to 10 of 94Source ClinicalTrials.gov

See all 94 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	0	201
Total, all-cause mortality	Paromomycin	0	198
Total, other adverse events	WR 279,396	201	201
Total, other adverse events	Paromomycin	198	198
Total, serious adverse events	WR 279,396	2	201
Total, serious adverse events	Paromomycin	1	198

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
WR 279,396 vs Paromomycin: deaths from any cause	Trial comparisons
WR 279,396 vs Paromomycin: 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.

GET https://conductscience.org/api/trials/v1/NCT01790659

GET https://conductscience.org/api/trials/v1/NCT01790659/results?page=2

API reference For AI assistants