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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00606580
First received: January 21, 2008
Last updated: June 11, 2014
Last verified: June 2014
History of Changes
Results First Received: May 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cutaneous Leishmaniasis
Interventions: Drug: WR 279,396 topical cream
Drug: Paromomycin Alone topical cream
Drug: Vehicle placebo cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
WR 279,396 Topical Treament

WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)

WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
Paromomycin Alone Topical Treatment

Paromomycin Alone topical cream (15% paromomycin topical cream)

Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
Vehicle Placebo Cream

The cream base without the addition of paromomycin or gentamicin

Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.

Participant Flow:   Overall Study
    WR 279,396 Topical Treament   Paromomycin Alone Topical Treatment   Vehicle Placebo Cream
STARTED   125   125   125 
COMPLETED   123   122   103 
NOT COMPLETED   2   3   22 
Lost to Follow-up                1                1                4 
Clinical failures                1                0                12 
Withdrawal by investigator                0                1                6 
Withdrawal by Subject                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
WR 279,396 Topical Treament

WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)

WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
Paromomycin Alone Topical Treatment

Paromomycin Alone topical cream (15% paromomycin topical cream)

Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
Vehicle Placebo Cream

The cream base without the addition of paromomycin or gentamicin

Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
Total Total of all reporting groups

Baseline Measures
   WR 279,396 Topical Treament   Paromomycin Alone Topical Treatment   Vehicle Placebo Cream   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 125   125   125   375 
Age 
[Units: Years]
Mean (Standard Deviation) 		 23.4  (15.9)   24.6  (15.7)   23.2  (15.2)   23.7  (15.6) 
Age, Customized 
[Units: Participants]
 		       
Adults   63   66   61   190 
Children (12 to 17)   24   33   35   92 
Children (5 to 11)   38   26   29   93 
Gender 
[Units: Participants]
 		       
Female   69   57   56   182 
Male   56   68   69   193 
Race/Ethnicity, Customized 
[Units: Participants]
 		       
North African   125   125   125   375 
Total Number of lesions per subject 
[Units: Participants]
 		       
1 lesion   59   49   50   158 
More than 1 lesions   66   76   75   217 
All lesion characteristics 
[Units: Lesions]
 		       
Number of   243   272   282   797 
Flat-like   0   1   0   1 
Nodule   0   1   0   1 
Other   3   7   3   13 
Papule   0   1   0   1 
Ulcerative   240   262   279   781 
Index lesion ulceration area [1] 
[Units: Mm^2]
Mean (Standard Deviation) 		 126  (121)   90.2  (74.5)   97.7  (112)   105  (105) 
[1] Index lesion ulceration area per participant
Index lesion 
[Units: Participants]
 		       
Area of ulceration ≤ 100 m^2   72   84   89   245 
Area of ulceration > 100 mm^2   53   41   36   130 
All lesion ulceration area [1] 
[Units: Mm^2]
Mean (Standard Deviation) 		 86.8  (107)   65.6  (91.1)   70.3  (91.4)   73.8  (96.5) 
[1] Lesion ulceration area per lesion independent of participant
All ulcerated lesions 
[Units: Lesions]
 		       
Area of ulceration ≤ 100 m^2   175   210   222   607 
Area of ulceration > 100 mm^2   65   52   57   174 
Days before treatment that index lesion was first noticed 
[Units: Days]
Mean (Standard Deviation) 		 39.3  (25.7)   39.5  (20.0)   38.9  (20.5)   39.2  (22.2) 
Days before treatment that index lesion was first noticed (categorical) 
[Units: Participants]
 		       
≤ 60 days   110   109   109   328 
> 60 days   15   16   16   47 


  Outcome Measures
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1.  Primary:   Final Clinical Cure Rate   [ Time Frame: Day 42, 98, and 168 ]
  Show Outcome Measure 1

2.  Secondary:   Final Clinical Cure Rate (Per Protocol Dataset)   [ Time Frame: Day 42, 98, and 168 ]
  Show Outcome Measure 2

3.  Secondary:   Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse   [ Time Frame: Day 42 ]
  Show Outcome Measure 3

4.  Secondary:   Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up   [ Time Frame: Days 42, 49, and 98 ]
  Show Outcome Measure 4

5.  Secondary:   Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42   [ Time Frame: Days 42 ]
  Show Outcome Measure 5

6.  Secondary:   Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49   [ Time Frame: Days 49 ]
  Show Outcome Measure 6

7.  Secondary:   Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98   [ Time Frame: Days 98 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion   [ Time Frame: Day 42 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse   [ Time Frame: Day 168 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse   [ Time Frame: Day 168 ]
  Show Outcome Measure 10

11.  Secondary:   Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42   [ Time Frame: Day 42 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects With a Relapse on or After Day 42   [ Time Frame: Day 168 ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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  More Information
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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: Division of Regulated Activies and Compliance
Organization: US Army Medical Materiel Development Activity (USAMMDA)
phone: 301-619-0317
e-mail: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory-affairs@mail.mil


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00606580     History of Changes
Other Study ID Numbers: A-14134
Study First Received: January 21, 2008
Results First Received: May 12, 2014
Last Updated: June 11, 2014