A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964223
First received: August 20, 2009
Last updated: February 23, 2012
Last verified: February 2012
Results First Received: September 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
Drug: benzoyl peroxide and adapalene gel (EPIDUO™ 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 centers

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
All Study Participants Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Participant Flow for 2 periods

Period 1:   Split Face Treatment (Weeks 1 and 2)
    All Study Participants  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  

Period 2:   Full Face Treatment (Weeks 5 and 8)
    All Study Participants  
STARTED     28  
COMPLETED     27  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  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
All Study Participants Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean ± Standard Deviation
  29.6  ± 9.5  
Gender  
[units: participants]
 
Female     24  
Male     4  
Race (NIH/OMB)  
[units: Participants]
 
Asian     2  
Black or African American     11  
White     15  
Region of Enrollment  
[units: participants]
 
United States     28  
Investigators Static Global Assessment (ISGA) [1]
[units: Participants]
 
Mild     2  
Moderate     20  
Severe     6  
Inflammatory Acne Lesion Count [2]
[units: Inflammatory¬†Lesion]
Mean ± Standard Deviation
  21.5  ± 9.3  
Non-Inflammatory Acne Lesion Count [3]
[units: Non-Inflammatory¬†lesion]
Mean ± Standard Deviation
  33.0  ± 24.7  
Total Acne Lesion Count [4]
[units: Acne¬†lesions]
Mean ± Standard Deviation
  54.5  ± 27.1  
[1] Patients with the following ISGA grades were eligible for enrollment on this study: 0, Clear: clear skin with no inflammatory lesions (IL) or non-inflammatory lesions (NIL); 1, Almost clear: rare NIL with no more than one small IL; 2, Mild: some NIL with no more than a few IL (papules/pustules only, no nodular lesions); 3, Moderate: up to many NIL and may have some IL, but no more than one small nodular lesion; 4, Severe: up to many NIL and IL, but no more than a few small nodular lesions; 5, Very severe: many NIL and IL and more than a few nodular lesions. May have cystic lesions.
[2] Inflammatory acne lesion count at baseline (number of pustules and papules).
[3] Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads)
[4] Total acne lesion count (includes inflammatory and non-inflammatory lesions)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Erythema (Redness) Score   [ Time Frame: Week 1, Week 2 ]

2.  Primary:   Skin Dryness Score   [ Time Frame: Week 1, Week 2 ]

3.  Primary:   Skin Peeling Score   [ Time Frame: Week 1, Week 2 ]

4.  Primary:   Irritant/Allergic Contact Dermatitis Score   [ Time Frame: Week 1, Week 2 ]

5.  Secondary:   Erythema (Redness) Score   [ Time Frame: Week 5, Week 8 ]

6.  Secondary:   Skin Dryness Score   [ Time Frame: Week 5, Week 8 ]

7.  Secondary:   Skin Peeling Score   [ Time Frame: Week 5, Week 8 ]

8.  Secondary:   Irritant/Allergic Contact Dermatitis Score   [ Time Frame: Week 5, Week 8 ]

9.  Secondary:   Investigator Static Global Assessment Score   [ Time Frame: Week 5, Week 8 ]

10.  Secondary:   Inflammatory Acne Lesion Counts   [ Time Frame: Week 5, Week 8 ]

11.  Secondary:   Non-Inflammatory Acne Lesion Counts   [ Time Frame: Week 5, Week 8 ]

12.  Secondary:   Total Acne Lesion Counts   [ Time Frame: Week 5, Week 8 ]

13.  Secondary:   Skindex-29 Quality of Life Questionnaire - Symptomatic Domain   [ Time Frame: Baseline, and Week 8 ]

14.  Secondary:   Skindex-29 Quality of Life Questionnaire - Emotional Domain   [ Time Frame: Baseline, and Week 8 ]

15.  Secondary:   Skindex-29 Quality of Life Questionnaire - Functional Domain   [ Time Frame: Baseline, and Week 8 ]

16.  Secondary:   Skindex-29 Quality of Life Questionnaire - Global Score   [ Time Frame: Baseline, and Week 8 ]

17.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Redness   [ Time Frame: Week 1, Week 2 ]

18.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Redness   [ Time Frame: Week 8 ]

19.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Dryness   [ Time Frame: Week 1, Week 2 ]

20.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Dryness   [ Time Frame: Week 8 ]

21.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Burning   [ Time Frame: Week 1, Week 2 ]

22.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Burning   [ Time Frame: Week 8 ]

23.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Itching   [ Time Frame: Week 1, Week 2 ]

24.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Itching   [ Time Frame: Week 8 ]

25.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Scaling   [ Time Frame: Week 1, Week 2 ]

26.  Secondary:   Product Acceptability and Preference Questionnaire - Severity of Scaling   [ Time Frame: Week 8 ]

27.  Secondary:   Product Acceptability and Preference Questionnaire - Ease of Application of Product   [ Time Frame: Week 1, Week 2 ]

28.  Secondary:   Product Acceptability and Preference Questionnaire - Ease of Application of Product   [ Time Frame: Week 8 ]

29.  Secondary:   Product Acceptability and Preference Questionnaire - Comfort of Skin   [ Time Frame: Week 1, Week 2 ]

30.  Secondary:   Product Acceptability and Preference Questionnaire - Comfort of Skin   [ Time Frame: Week 8 ]

31.  Secondary:   Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?   [ Time Frame: Week 1, Week 2 ]

32.  Secondary:   Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past   [ Time Frame: Week 8 ]

33.  Secondary:   Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products   [ Time Frame: Week 1, Week 2 ]

34.  Secondary:   Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products   [ Time Frame: Week 8 ]

35.  Secondary:   Product Acceptability and Preference Questionnaire - Compliance   [ Time Frame: Week 1, Week 2 ]

36.  Secondary:   Product Acceptability and Preference Questionnaire - Compliance   [ Time Frame: Week 8 ]

37.  Secondary:   Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin   [ Time Frame: Week 1, Week 2 ]

38.  Secondary:   Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin   [ Time Frame: Week 8 ]

39.  Secondary:   Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment   [ Time Frame: Week 1, Week 2 ]

40.  Secondary:   Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment   [ Time Frame: Week 8 ]

41.  Secondary:   Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up   [ Time Frame: Week 1, Week 2 ]

42.  Secondary:   Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up   [ Time Frame: Week 8 ]

43.  Secondary:   Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product   [ Time Frame: Week 1, Week 2 ]

44.  Secondary:   Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: Lou Barbato, MD
Organization: Stiefel, a GSK company
phone: 678-731-5592
e-mail: lou.barbato@stiefel.com


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00964223     History of Changes
Other Study ID Numbers: 114547, C0000-410
Study First Received: August 20, 2009
Results First Received: September 7, 2010
Last Updated: February 23, 2012
Health Authority: United States: Institutional Review Board