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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
History of Changes
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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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
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1.  Primary:   Erythema (Redness) Score   [ Time Frame: Week 1, Week 2 ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  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 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