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A Phase 4, Single-Blind, Randomized, Study to Compare the Tolerability and Efficacy of 0.1% Tazorac Cream When Used in Combination With Either Duac Gel or Acanya Gel for the Treatment of Facial Acne Vulgaris (C0000-411)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016977
First Posted: November 20, 2009
Last Update Posted: January 30, 2017
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: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene
Drug: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

  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
No text entered.

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
Tazorac Cream/Duac Gel Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
Tazorac Cream/Acanya Gel Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face

Participant Flow:   Overall Study
    Tazorac Cream/Duac Gel   Tazorac Cream/Acanya Gel
STARTED   20   20 
COMPLETED   17   18 
NOT COMPLETED   3   2 
Lost to Follow-up                1                0 
Withdrawal by Subject                2                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
Tazorac Cream/Duac Gel Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
Tazorac Cream/Acanya Gel Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
Total Total of all reporting groups

Baseline Measures
   Tazorac Cream/Duac Gel   Tazorac Cream/Acanya Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.2  (9.0)   22.6  (7.8)   21.9  (8.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      13  65.0%      9  45.0%      22  55.0% 
Male      7  35.0%      11  55.0%      18  45.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   8   15   23 
Black   1   1   2 
White   9   4   13 
Biracial, India, Black, and Phillipino   1   0   1 
Multiracial (Black, White)   1   0   1 


  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

2.  Primary:   Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

3.  Primary:   Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

4.  Primary:   Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

5.  Primary:   Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

6.  Primary:   Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

7.  Primary:   Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

8.  Secondary:   Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

10.  Secondary:   Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, and 12 ]

11.  Secondary:   Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

12.  Secondary:   Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

14.  Secondary:   Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12   [ Time Frame: Baseline and Week 12 ]

15.  Secondary:   Overall Satisfaction With Study Product at Week 12   [ Time Frame: Week 12 ]


  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 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: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01016977     History of Changes
Obsolete Identifiers: NCT01334970
Other Study ID Numbers: 114566
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: January 19, 2012
Results First Posted: February 23, 2012
Last Update Posted: January 30, 2017