A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01313728
First received: March 10, 2011
Last updated: February 14, 2012
Last verified: February 2012
Results First Received: October 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Dapsone plus Tretinoin Gel
Drug: Tretinoin Gel

  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
Overall Study This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.

Participant Flow for 2 periods

Period 1:   Informed Consent to Baseline
    Overall Study  
STARTED     26  
COMPLETED     25 [1]
NOT COMPLETED     1  
Withdrawal by Subject                 1  
[1] One subject withdrew after signing informed consent, but prior to Baseline measurements being taken.

Period 2:   Baseline to Completion
    Overall Study  
STARTED     25  
COMPLETED     25  
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
Overall Study This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  25  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     0  
Gender, Customized [1]
[units: Participants]
  25  
Region of Enrollment  
[units: participants]
 
United States     25  
Fitzpatrick Score [2]
[units: Participants]
 
Type I     1  
Type II     10  
Type III     14  
[1] Gender was not a relevant measure for the trial, and was not recorded. Number reported reflects Participants in the overall study who were either Male or Female.
[2] Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI). Only Skin Types I-III were included in this study.



  Outcome Measures
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1.  Primary:   Expert Grader Assessment - Erythema   [ Time Frame: Baseline to 2 Weeks ]

2.  Primary:   Expert Grader Assessment - Dryness   [ Time Frame: Baseline to 2 Weeks ]

3.  Secondary:   Subject Assessment – Burning/Stinging   [ Time Frame: Baseline to 2 Weeks ]

4.  Secondary:   Subject Assessment – Itching   [ Time Frame: Baseline to 2 Weeks ]

5.  Secondary:   Subject Assessment – Tightness   [ Time Frame: Baseline to 2 Weeks ]

6.  Secondary:   Facial Tolerance   [ Time Frame: Baseline to 2 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 less than or equal to 60 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


No publications provided


Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01313728     History of Changes
Other Study ID Numbers: CA-P-7966
Study First Received: March 10, 2011
Results First Received: October 14, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board