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
Results First Received: May 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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  
Number of Participants  
[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  
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 [2]
[units: mm^2]
Mean ± Standard Deviation
  86.8  ± 107     65.6  ± 91.1     70.3  ± 91.4     73.8  ± 96.5  
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  
[1] Index lesion ulceration area per participant
[2] Lesion ulceration area per lesion independent of participant



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

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

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

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 ]

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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


No publications provided by U.S. Army Medical Research and Materiel Command

Publications automatically indexed to this study:

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
Health Authority: United States: Food and Drug Administration
Tunisia: Ministry of Public Health