Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964366
First received: August 20, 2009
Last updated: March 6, 2012
Last verified: March 2012
Results First Received: April 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: clindamycin and benzoyl peroxide
Drug: Dapsone 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
Clinical research center. Subject recruitment occurred from July 16, 2009 to Aug. 11, 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.

Reporting Groups
  Description
Clindamycin and BPO Gel Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Dapsone Gel Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).

Participant Flow:   Overall Study
    Clindamycin and BPO Gel     Dapsone Gel  
STARTED     28 [1]   25  
COMPLETED     27     24  
NOT COMPLETED     1     1  
Did not qualify at Day 1                 1                 0  
Withdrawal by Subject                 0                 1  
[1] 27 of the 28 enrolled were eligible after screening.



  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
Clindamycin and BPO Gel Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Dapsone Gel Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
Total Total of all reporting groups

Baseline Measures
    Clindamycin and BPO Gel     Dapsone Gel     Total  
Number of Participants  
[units: participants]
  28     25     53  
Age  
[units: participants]
     
<=18 years     2     1     3  
Between 18 and 65 years     26     24     50  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     21     22     43  
Male     7     3     10  
Region of Enrollment  
[units: participants]
     
United States     28     25     53  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Skin Erythema (Redness)   [ Time Frame: 2 Weeks ]

2.  Primary:   Skin Dryness   [ Time Frame: Baseline, Day 1through Day 14 ]

3.  Secondary:   Transepidermal Water Loss (TEWL)   [ Time Frame: 2 Weeks ]

4.  Secondary:   Sebum Measurements   [ Time Frame: 2 weeks ]

5.  Secondary:   Skin Hydration   [ Time Frame: 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 888-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00964366     History of Changes
Other Study ID Numbers: 114545, C0000-408
Study First Received: August 20, 2009
Results First Received: April 13, 2010
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board