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A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887484
First Posted: April 24, 2009
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
Results First Submitted: September 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: BENZOYL PEROXIDE/ CLINDAMYCIN
Drug: BENZOYL PEROXIDE/ ADAPALENE

  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
No text entered.

Reporting Groups
  Description
Clindoxyl and Epiduo Gels Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.

Participant Flow for 2 periods

Period 1:   Split Face Treatment (Weeks 1 and 2)
    Clindoxyl and Epiduo Gels
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 

Period 2:   Full Face Treatment (Weeks 5 and 8)
    Clindoxyl and Epiduo Gels
STARTED   48 
COMPLETED   45 
NOT COMPLETED   3 
Adverse Event                1 
Lost to Follow-up                1 
Pregnancy                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
Clindoxyl and Epiduo Gels Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.

Baseline Measures
   Clindoxyl and Epiduo Gels 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.6  (5.5) 
Gender 
[Units: Participants]
Count of Participants
 
Female      10  20.8% 
Male      38  79.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      33  68.8% 
Not Hispanic or Latino      15  31.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      48 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
Argentina   48 
Investigators Static Global Assessment (ISGA) [1] 
[Units: Participants]
 
Mild   14 
Moderate   31 
Severe   3 
[1] The investigator rated the participants’ skin using the 6-point ISGA: 0=clear, clear skin with no inflammatory lesions (ILs) or non-ILs; 1=almost clear, rare non-ILs with no more than one small IL; 2=mild, some non-ILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many non-ILs and may have some ILs, but no more than one small NL; 4=severe, up to many non-IL and ILs, but no more than a few NLs; 5=many non-IL and ILs and more than a few NLs. May have cystic lesions. Participants with grades of 2-4 were eligible for enrollment in this study.
Inflammatory Acne Lesion Count [1] 
[Units: Inflammatory lesions]
Mean (Standard Deviation)
 14.2  (9.1) 
[1] Inflammatory acne lesion count at baseline (number of pustules and papules).
Non-Inflammatory Acne Lesion Count [1] 
[Units: Non-Infammatory acne lesions]
Mean (Standard Deviation)
 24.8  (12.8) 
[1] Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads)
Total Acne Lesion Count [1] 
[Units: Acne lesions]
Mean (Standard Deviation)
 39.1  (13.0) 
[1] Total acne lesion count (includes inflammatory and non-inflammatory lesions)


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Skin Dryness   [ Time Frame: Weeks 1 and 2 ]

3.  Primary:   Skin Peeling   [ Time Frame: Weeks 1 and 2 ]

4.  Primary:   Irritant/Allergic Contact Dermatitis   [ Time Frame: Weeks 1 and 2 ]

5.  Secondary:   Erythema (Redness)   [ Time Frame: Weeks 5 and 8 ]

6.  Secondary:   Skin Dryness   [ Time Frame: Weeks 5 and 8 ]

7.  Secondary:   Skin Peeling   [ Time Frame: Weeks 5 and 8 ]

8.  Secondary:   Irritant/Allergic Contact Dermatitis   [ Time Frame: Weeks 5 and 8 ]

9.  Secondary:   Investigators Static Global Assessment   [ Time Frame: Baseline, Weeks 5, 8 ]

10.  Secondary:   Total Acne Lesion Counts   [ Time Frame: Baseline, Weeks 5 and 8 ]

11.  Secondary:   Inflammatory Acne Lesion Counts   [ Time Frame: Baseline, Weeks 5 and 8 ]

12.  Secondary:   Non-inflammatory Acne Lesion Counts   [ Time Frame: Baseline, Weeks 5 and 8 ]

13.  Secondary:   Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain   [ Time Frame: Baseline, Weeks 2 and 8 ]

14.  Secondary:   Quality of Life Questionnaire - Emotional Domain   [ Time Frame: Baseline, Weeks 2 and 8 ]

15.  Secondary:   Quality of Life Questionnaire - Functional Domain   [ Time Frame: Baseline, Weeks 2 and 8 ]

16.  Secondary:   Quality of Life Questionnaire - Global Score   [ Time Frame: Baseline, Weeks 2 and 8 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

41.  Secondary:   Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2   [ Time Frame: Weeks 1 and 2 ]

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

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

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


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 888-435-7343



Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00887484     History of Changes
Other Study ID Numbers: 114544
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: September 22, 2010
Results First Posted: October 23, 2012
Last Update Posted: December 13, 2016