Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00919191
First received: June 10, 2009
Last updated: February 14, 2012
Last verified: February 2012
Results First Received: December 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Tretinoin gel
Drug: Adapalene and Benzoyl peroxide

  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
Tretinoin and Adapalene Benzoyl Peroxide Facial Gels One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.

Participant Flow:   Overall Study
    Tretinoin and Adapalene Benzoyl Peroxide Facial Gels  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     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.
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Reporting Groups
  Description
Tretinoin and Adapalene Benzoyl Peroxide Facial Gels One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.

Baseline Measures
    Tretinoin and Adapalene Benzoyl Peroxide Facial Gels  
Number of Participants  
[units: participants]
  26  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.1  ± 5.8  
Gender  
[units: participants]
 
Female     26  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Comparative Assessment of Facial Irritation and Cutaneous Effects.   [ Time Frame: Daily, for 3 weeks ]

2.  Secondary:   Self Assessment of Burning/Stinging and Itching   [ Time Frame: Daily, for 3 weeks ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Lineberry, Associate Director, Clinical Operations
Organization: Valeant Pharmaceuticals International, Inc
phone: 949-973-1153
e-mail: David.Lineberry@valeant.com


Publications of Results:

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00919191     History of Changes
Other Study ID Numbers: CA-P-6805
Study First Received: June 10, 2009
Results First Received: December 28, 2009
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board