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Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00807014
First received: December 10, 2008
Last updated: March 15, 2012
Last verified: February 2012
History of Changes
Results First Received: November 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Duac Gel
Drug: Differin 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
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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
Duac Gel Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks

Participant Flow:   Overall Study
    Duac Gel     Differin Gel  
STARTED     83     85  
COMPLETED     56     58  
NOT COMPLETED     27     27  
Participant Considered Disease Cured                 13                 2  
Participant Considered Disease Not Cured                 2                 7  
Protocol Violation                 2                 8  
Adverse Event                 0                 2  
Lost to Follow-up                 9                 7  
Recovery                 1                 0  
Missed Visit 2 Due to Personal Reasons                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Duac Gel Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Duac Gel     Differin Gel     Total  
Number of Participants  
[units: participants]
 		  83     85     168  
Age  
[units: Years]
Mean ± Standard Deviation 		  18.9  ± 5.3     19.2  ± 5.3     19.1  ± 5.3  
Gender  
[units: Participants]
 		     
Female     59     65     124  
Male     24     20     44  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     75     77     152  
Asian     2     1     3  
Black     1     0     1  
Mixed or Multiracial     2     3     5  
Captured as "Other" on Case Report Form     3     4     7  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire   [ Time Frame: Baseline (Week 0) and Week 2 ]
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2.  Secondary:   Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire   [ Time Frame: Baseline (Week 0) and Week 12 ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts   [ Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts   [ Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 ]
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5.  Secondary:   Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2   [ Time Frame: Baseline (Week 0) and Week 2 ]
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Measure Type Secondary
Measure Title Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2
Measure Description Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman’s correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.
Time Frame Baseline (Week 0) and Week 2  
Safety Issue No  

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.
ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.

Reporting Groups
  Description
Duac Gel Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks

Measured Values
    Duac Gel     Differin Gel  
Number of Participants Analyzed  
[units: participants]
 		  83     84  
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2  
[units: Correlation coefficient]
 		   
Functional Domain     0.042     -0.094  
Symptomatic Domain     0.166     0.002  
Emotional Domain     0.237     -0.137  
Global Score     0.223     -0.087  

No statistical analysis provided for Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2



6.  Secondary:   Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)   [ Time Frame: Start of treatment and Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 6

7.  Secondary:   Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)   [ Time Frame: Start of treatment and Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 7

8.  Secondary:   Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System   [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness   [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning   [ Time Frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination   [ Time Frame: Week 12 or Early Termination ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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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 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.


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.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00807014     History of Changes
Other Study ID Numbers: 114567, S194-SP-05/Duac
Study First Received: December 10, 2008
Results First Received: November 23, 2011
Last Updated: March 15, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica