Trial · NCT01083576
Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
NCT01083576, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2014-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama. Trials, record NCT01083576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01083576
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
- NCT number
- NCT01083576
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Leishmaniasis, Cutaneous
- Interventions
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream), Paromomycin Alone Cream (15% paromomycin topical cream)
- First posted
- 2010-03-09
- Last updated
- 2015-07-16
- Results first posted
- 2014-05-15
- Limitations and caveats
- There are no PK tables for gentamicin due to low sample size; only 2 individuals with measureable gentamicin.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Obtained Final Clinical Cure of Index Lesion | 168 days | Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (\> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion. |
| Secondary | Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | 168 days | Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions) |
| Secondary | Detectable Paromomycin or Gentamicin Plasma Levels | 20 days | Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected |
| Secondary | Paromomycin Plasma Concentrations in Adults | Day 4 to Day 28 | Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults |
| Secondary | Paromomycin Plasma Concentrations in Children | Days 1 and 20 | Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children |
| Secondary | Pharmacokinetic Parameter: Cmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: Tmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: Area Under the Curve (AUC) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: t(1/2) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: Cmax/D | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Obtained Final Clinical Cure of Index Lesion | 168 days | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | 168 days | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | Participants | NUMBER |
| SECONDARY | Detectable Paromomycin or Gentamicin Plasma Levels | 20 days | Adults ages \>= 17 years | Participants | NUMBER |
| SECONDARY | Paromomycin Plasma Concentrations in Adults | Day 4 to Day 28 | Adults ages \>= 17 years | ng/mL | MEAN |
| SECONDARY | Paromomycin Plasma Concentrations in Children | Days 1 and 20 | Children ages 7 to 16 | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Cmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults with measurable samples. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Tmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1. | hr | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Area Under the Curve (AUC) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. | ng*hr/mL | MEAN |
| OTHER_PRE_SPECIFIED | Serum Creatinine Levels | Day 1 and Day 20 | All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset. | mg/dL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: t(1/2) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults ages \>= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20. | hr | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Obtained Final Clinical Cure of Index Lesion | Paromomycin Alone Treatment | 9 | Participants | ||
| Number of Participants Who Obtained Final Clinical Cure of Index Lesion | WR 279,396 | 13 | Participants | ||
| Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | Paromomycin Alone Treatment | 8 | Participants | ||
| Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | WR 279,396 | 13 | Participants | ||
| Detectable Paromomycin or Gentamicin Plasma Levels | Paromomycin Alone Treatment | Any detectable gentamicin | 0 | Participants | |
| Detectable Paromomycin or Gentamicin Plasma Levels | WR 279,396 | Any detectable gentamicin | 1 | Participants | |
| Detectable Paromomycin or Gentamicin Plasma Levels | Paromomycin Alone Treatment | Any detectable paromomycin | 8 | Participants | |
| Detectable Paromomycin or Gentamicin Plasma Levels | WR 279,396 | Any detectable paromomycin | 8 | Participants | |
| Paromomycin Plasma Concentrations in Adults | Paromomycin Alone Treatment | Day 4 | 0 | Standard Deviation 0 | ng/mL |
| Paromomycin Plasma Concentrations in Adults | WR 279,396 | Day 4 | 17.8 | Standard Deviation 38.0 | ng/mL |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paromomycin Alone Treatment | 15 | |
| Overall Study | STARTED | WR 279,396 | 15 | |
| Overall Study | COMPLETED | Paromomycin Alone Treatment | 9 | |
| Overall Study | COMPLETED | WR 279,396 | 14 | |
| Overall Study | NOT COMPLETED | Paromomycin Alone Treatment | 6 | |
| Overall Study | NOT COMPLETED | WR 279,396 | 1 |
Source ClinicalTrials.gov
Adverse events16
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 | Paromomycin Alone Treatment | 2 | 15 | |
| other | Application site erythema | General disorders | WR 279,396 | 3 | 15 | |
| other | Application site oedema | General disorders | Paromomycin Alone Treatment | 3 | 15 | |
| other | Application site oedema | General disorders | WR 279,396 | 2 | 15 | |
| other | Application site pain | General disorders | Paromomycin Alone Treatment | 5 | 15 | |
| other | Application site pain | General disorders | WR 279,396 | 1 | 15 | |
| other | Superinfection bacterial | Infections and infestations | Paromomycin Alone Treatment | 0 | 15 | |
| other | Superinfection bacterial | Infections and infestations | WR 279,396 | 1 | 15 | |
| other | Folliculitis | Infections and infestations | Paromomycin Alone Treatment | 1 | 15 | |
| other | Folliculitis | Infections and infestations | WR 279,396 | 0 | 15 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paromomycin Alone Treatment | ||
| Total, all-cause mortality | WR 279,396 | ||
| Total, other adverse events | Paromomycin Alone Treatment | 14 | 15 |
| Total, other adverse events | WR 279,396 | 15 | 15 |
| Total, serious adverse events | Paromomycin Alone Treatment | 0 | 15 |
| Total, serious adverse events | WR 279,396 | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23877689 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paromomycin Alone Treatment vs WR 279,396: Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions | Trial comparisons |
| Paromomycin Alone Treatment vs WR 279,396: Number of Participants Who Obtained Final Clinical Cure of Index Lesion | Trial comparisons |
| Paromomycin Alone Treatment vs WR 279,396: 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/NCT01083576
GET https://conductscience.org/api/trials/v1/NCT01083576/results?page=2