A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT01017120
First received: November 19, 2009
Last updated: May 31, 2012
Last verified: May 2012
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Tazarotene Foam
Drug: Vehicle Foam

  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
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Reporting Groups
  Description
Tazarotene Foam Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Vehicle Foam The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.

Participant Flow:   Overall Study
    Tazarotene Foam     Vehicle Foam  
STARTED     373     369  
COMPLETED     307     334  
NOT COMPLETED     66     35  
Adverse Event                 9                 0  
Lost to Follow-up                 13                 11  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 39                 21  
Pregnancy                 1                 1  
Did Not Meet Eligibility Criteria                 1                 0  
Relocated Out of Town                 0                 2  
Protocol Violation                 1                 0  
Parent Unable to Provide Transportation                 1                 0  



  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.
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Reporting Groups
  Description
Tazarotene Foam Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Vehicle Foam The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Total Total of all reporting groups

Baseline Measures
    Tazarotene Foam     Vehicle Foam     Total  
Number of Participants  
[units: participants]
  373     369     742  
Age  
[units: Years]
Mean ± Standard Deviation
     
Years     19.2  ± 6.5     19.2  ± 6.8     19.2  ± 6.6  
Gender  
[units: Participants]
     
Female     197     185     382  
Male     176     184     360  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaskan Native     2     2     4  
Asian     28     21     49  
Black     60     57     117  
Native Hawaiian or Other Pacific Islander     0     4     4  
White     278     280     558  
Mixed Race     5     5     10  



  Outcome Measures
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1.  Primary:   Absolute Change in Lesion Counts (LCs) From Baseline to Week 12   [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ]

2.  Primary:   Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12   [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ]

3.  Primary:   Number of Participants With an ISGA Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

5.  Secondary:   Absolute Change From Baseline in LC at Weeks 2, 4, and 8   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ]

6.  Secondary:   Time to a 50 Percent Reduction in Total Lesion Counts (TLC)   [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

7.  Secondary:   Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ]

8.  Secondary:   Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8   [ Time Frame: Weeks 2, 4, and 8 ]

9.  Secondary:   Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12   [ Time Frame: Weeks 2, 4, 8, and 12 ]

10.  Secondary:   Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

11.  Secondary:   Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

12.  Secondary:   Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

14.  Secondary:   Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

15.  Secondary:   Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

16.  Secondary:   Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older   [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

17.  Secondary:   Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger   [ Time Frame: Baseline (Week 0/Day 1); Week 2, 4, 8, and 12 ]

18.  Secondary:   Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator   [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

19.  Secondary:   Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator   [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

20.  Secondary:   Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator   [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

21.  Secondary:   Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants   [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

22.  Secondary:   Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants   [ Time Frame: Baseline (Week 0/Day 1) to 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


No publications provided


Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01017120     History of Changes
Other Study ID Numbers: 114576, W0260-302
Study First Received: November 19, 2009
Results First Received: May 31, 2012
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration