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Trial record 53 of 274 for:    Panama

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

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ClinicalTrials.gov Identifier: NCT01083576
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : May 15, 2014
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Leishmaniasis, Cutaneous
Interventions Drug: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)
Drug: Paromomycin Alone Cream (15% paromomycin topical cream)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Period Title: Overall Study
Started 15 15
Completed 9 14
Not Completed 6 1
Reason Not Completed
Treatment Failure             6             1
Arm/Group Title Paromomycin Alone Treatment WR 279,396 Total
Hide Arm/Group Description Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
24.0  (16.2) 25.5  (15.9) 24.7  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
2
  13.3%
4
  26.7%
6
  20.0%
Male
13
  86.7%
11
  73.3%
24
  80.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Mestizo 14 15 29
Other 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Number of Participants Who Obtained Final Clinical Cure of Index Lesion
Hide Description 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.
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Participants
9 13
2.Secondary Outcome
Title Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions
Hide Description 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)
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Participants
8 13
3.Secondary Outcome
Title Detectable Paromomycin or Gentamicin Plasma Levels
Hide Description Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected
Time Frame 20 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: Participants
Any detectable gentamicin 0 1
Any detectable paromomycin 8 8
4.Secondary Outcome
Title Paromomycin Plasma Concentrations in Adults
Hide Description Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults
Time Frame Day 4 to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 4 0  (0) 17.8  (38.0)
Day 7 13.1  (37.1) 17.6  (34.9)
Day 12 6.6  (18.8) 26.4  (40.8)
Day 17 44.0  (49.8) 26.3  (52.3)
Day 20 54.6  (48.4) 31.4  (47.8)
Day 28 0  (0) 0  (0)
5.Secondary Outcome
Title Paromomycin Plasma Concentrations in Children
Hide Description Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children
Time Frame Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Children ages 7 to 16
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
Study Day 1 116.3  (83.6) 98.6  (132.3)
Study Day 20 992.7  (1149.7) 634.2  (426.2)
6.Secondary Outcome
Title Pharmacokinetic Parameter: Cmax
Hide Description Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Time Frame 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Adults with measurable samples.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 1 219.0  (294) 121  (106)
Day 20 751.0  (609.0) 561.0  (560.0)
7.Secondary Outcome
Title Pharmacokinetic Parameter: Tmax
Hide Description Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Time Frame 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: hr
Day 1 2.7  (1.2) 2.8  (2.6)
Day 20 2.2  (0.8) 2.2  (1.4)
8.Secondary Outcome
Title Pharmacokinetic Parameter: Area Under the Curve (AUC)
Hide Description Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Time Frame 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years with measurable samples.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Day 1 1571  (1850) 863.4  (974.0)
Day 20 5603  (4050) 4740  (3987)
9.Secondary Outcome
Title Pharmacokinetic Parameter: t(1/2)
Hide Description t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Time Frame 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 7 8
Mean (Standard Deviation)
Unit of Measure: hr
Day 1 7.03  (7.67) 4.0  (1.9)
Day 20 5.3  (2.1) 7.0  (3.6)
10.Secondary Outcome
Title Pharmacokinetic Parameter: Cmax/D
Hide Description 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
Time Frame 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years with measurable samples.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: 1/ML
Day 1 104.0  (104.0) 61.3  (64.0)
Day 20 227  (71) 179  (128)
11.Secondary Outcome
Title Pharmacokinetic Parameter: AUC/D
Hide Description Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama
Time Frame Days 1 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Adults ages >= 17 years with measurable samples.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: hr/ML
Day 1 715.2  (748.1) 345.9  (303.9)
Day 20 1725  (530) 1380  (631)
12.Other Pre-specified Outcome
Title Serum Creatinine Levels
Hide Description Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides
Time Frame Day 1 and Day 20
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description:
Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Study Day 1 0.83  (0.23) 0.79  (0.27)
Study Day 20 0.77  (0.26) 0.76  (0.22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paromomycin Alone Treatment WR 279,396
Hide Arm/Group Description Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
All-Cause Mortality
Paromomycin Alone Treatment WR 279,396
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paromomycin Alone Treatment WR 279,396
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paromomycin Alone Treatment WR 279,396
Affected / at Risk (%) Affected / at Risk (%)
Total   14/15 (93.33%)   15/15 (100.00%) 
General disorders     
Application site erythema   2/15 (13.33%)  3/15 (20.00%) 
Application site oedema   3/15 (20.00%)  2/15 (13.33%) 
Application site pain   5/15 (33.33%)  1/15 (6.67%) 
Infections and infestations     
Superinfection bacterial   0/15 (0.00%)  1/15 (6.67%) 
Folliculitis   1/15 (6.67%)  0/15 (0.00%) 
Mucocutaneous leishmaniasis   1/15 (6.67%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Burning sensation   0/15 (0.00%)  1/15 (6.67%) 
Dermatitis contact   8/15 (53.33%)  6/15 (40.00%) 
Indicates events were collected by systematic assessment
There are no PK tables for gentamicin due to low sample size; only 2 individuals with measureable gentamicin.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director, Division of Regulated Activites and Compliance
Organization: US Army Medical Materiel Development Activity (USAMMDA)
Phone: 301-619-0197
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01083576     History of Changes
Other Study ID Numbers: PG-PANAMA-08-04; A-15810
First Submitted: March 8, 2010
First Posted: March 9, 2010
Results First Submitted: November 20, 2013
Results First Posted: May 15, 2014
Last Update Posted: July 16, 2015