Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00926367
First received: June 21, 2009
Last updated: July 11, 2011
Last verified: July 2011
Results First Received: September 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Clindamycin and benzoyl peroxide
Drug: benzoyl peroxide 2.5% and adapalene 0.1% 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.

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
Duac Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Epiduo Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene

Participant Flow:   Overall Study
    Duac     Epiduo  
STARTED     25     27  
COMPLETED     23     24  
NOT COMPLETED     2     3  
Withdrawal by Subject                 0                 1  
Lost to Follow-up                 1                 0  
Skin Irritation                 1                 2  



  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
Duac Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
Epiduo Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Total Total of all reporting groups

Baseline Measures
    Duac     Epiduo     Total  
Number of Participants  
[units: participants]
  25     27     52  
Age  
[units: participants]
     
<=18 years     1     1     2  
Between 18 and 65 years     24     26     50  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     23     26     49  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     25     27     52  



  Outcome Measures
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1.  Primary:   Skin Erythema (Redness)   [ Time Frame: Baseline, Day 1 through Day 14 ]

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

3.  Secondary:   Skin Moisture and Hydration   [ Time Frame: Baseline, Days 3, 7, and 14 ]

4.  Secondary:   Skin Hydration   [ Time Frame: Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14 ]

5.  Secondary:   Self Assessment of Burning   [ Time Frame: Baseline, Day 1 through Day 14 ]

6.  Secondary:   Self Assessment of Stinging   [ Time Frame: Baseline, Day 1 through Day 14 ]

7.  Secondary:   Self Assessment of Dryness   [ Time Frame: Baseline, Day 1 through Day 14 ]

8.  Secondary:   Self Assessment of Texture (Roughness)   [ Time Frame: Baseline, Day 1 through Day 14 ]

9.  Secondary:   Self Assessment of Pain   [ Time Frame: Baseline, Day 1 through Day 14 ]

10.  Secondary:   Self Assessment of Crusting   [ Time Frame: Baseline, Day 1 through Day 14 ]

11.  Secondary:   Self Assessment of Blistering   [ Time Frame: Baseline, Day 1 through Day 14 ]

12.  Secondary:   Self Assessment of Oiliness   [ Time Frame: Baseline, Day 1 through Day 14 ]

13.  Secondary:   Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?   [ Time Frame: Day 14 ]

14.  Secondary:   Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?   [ Time Frame: Day 14 ]

15.  Secondary:   Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?   [ Time Frame: Day 14 ]

16.  Secondary:   Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?   [ Time Frame: Day 14 ]

17.  Secondary:   Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?   [ Time Frame: Day 14 ]

18.  Secondary:   Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?   [ Time Frame: Day 14 ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00926367     History of Changes
Other Study ID Numbers: C0000-405
Study First Received: June 21, 2009
Results First Received: September 7, 2010
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board