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A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00689117
First received: May 24, 2008
Last updated: September 22, 2011
Last verified: August 2011
Results First Received: November 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acne Vulgaris
Acne
Interventions: Drug: CT Gel
Drug: Clindamycin Gel (clindamycin )
Drug: Tretinoin Gel (tretinoin)
Drug: Vehicle 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
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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
CT Gel Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Clindamycin Gel Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Tretinoin Gel Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Vehicle Gel Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks

Participant Flow:   Overall Study
    CT Gel   Clindamycin Gel   Tretinoin Gel   Vehicle Gel
STARTED   476   467   464   242 
COMPLETED   414   416   405   211 
NOT COMPLETED   62   51   59   31 
Adverse Event                6                0                5                0 
Lost to Follow-up                26                19                17                11 
Lack of Efficacy                1                2                2                2 
Non-Compliance with Study Treatment                3                3                3                1 
Withdrawal by Subject                19                18                26                13 
Unable to Comply with Visit Schedule                0                0                1                1 
Inclusion/Exclusion Criteria Not Met                1                2                0                0 
Non-compliance with Treatment Regimen                0                1                0                0 
Change/Discontinuation of Birth Control                1                1                1                0 
Use of Prohibitive Medication                2                1                3                0 
Pregnancy                0                2                0                2 
Incarceration                2                0                0                0 
Fear of Birth Defects                0                0                1                0 
Transportation                1                0                0                0 
Patient Withdrew from Study                0                0                0                1 
Personal Reason                0                1                0                0 
Dispensing Error                0                1                0                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.
No text entered.

Reporting Groups
  Description
CT Gel Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Clindamycin Gel Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Tretinoin Gel Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Vehicle Gel Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Total Total of all reporting groups

Baseline Measures
   CT Gel   Clindamycin Gel   Tretinoin Gel   Vehicle Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 476   467   464   242   1649 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.8  (8.5)   20.2  (8.1)   20.2  (7.7)   20.6  (8.4)   20.4  (8.1) 
Gender 
[Units: Participants]
         
Female   269   266   264   153   952 
Male   207   201   200   89   697 
Race/Ethnicity, Customized 
[Units: Participants]
         
American Indian or Alaska Native   4   4   4   3   15 
Asian   8   8   11   5   32 
Black   94   85   103   51   333 
Multiracial   12   16   19   5   52 
Native Hawaiian/Other Pacific Islander   0   4   2   1   7 
White   358   349   324   176   1207 
Missing   0   1   1   1   3 


  Outcome Measures
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1.  Primary:   Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

5.  Secondary:   The Percentage of Participants Who Had ISGA Scores of 0 or 1 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



Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00689117     History of Changes
Other Study ID Numbers: 114681
W0265-03 ( Other Identifier: Stiefel )
Study First Received: May 24, 2008
Results First Received: November 2, 2010
Last Updated: September 22, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration