We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00703924
Previous Study | Return to List | Next Study

Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703924
First Posted: June 24, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
Results First Submitted: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cutaneous Leishmaniasis
Interventions: Drug: WR 279,396
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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

WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin

WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion

Placebo

Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion


Participant Flow:   Overall Study
    WR 279,396   Placebo
STARTED   50   42 
COMPLETED   49   41 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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

WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin

WR 279,396: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion

Placebo

Topical cream vehicle containing all of the components in WR 279,396 except the active ingredients.

Placebo: Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion

Total Total of all reporting groups

Baseline Measures
   WR 279,396   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   42   92 
Age, Customized 
[Units: Years]
     
<18 years   47   33   80 
>18 years   3   9   12 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  46.0%      15  35.7%      38  41.3% 
Male      27  54.0%      27  64.3%      54  58.7% 
Region of Enrollment 
[Units: Participants]
     
France   5   5   10 
Tunisia   45   37   82 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)   [ Time Frame: 180 days ]

2.  Primary:   Safety of WR 279,396 (AEs and SAEs)   [ Time Frame: 180 days ]

3.  Secondary:   Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse   [ Time Frame: 180 days ]

4.  Secondary:   Final Cure Rate by Subject of All Lesions   [ Time Frame: 180 days ]

5.  Secondary:   Rate of Relapse   [ Time Frame: 180 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Afif Ben Salah, MD, PhD
Organization: Institute Pasteur Tunisia
phone: 216-71-792-429
e-mail: afif.bensalah@pasteur.rns.tn


Publications of Results:

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00703924     History of Changes
Other Study ID Numbers: A-9768.1
IND 50098 ( Other Identifier: FDA )
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: December 21, 2016
Results First Posted: February 15, 2017
Last Update Posted: May 30, 2017