Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01047189
First received: January 11, 2010
Last updated: November 9, 2011
Last verified: November 2011
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
Drug: clindamycin 1% gel
Drug: tretinoin 0.025% cream

  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
Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic

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
Ziana Gel Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Clindamycin Plus Tretinoin Applied Separately Generic clindamycin 1% gel plus tretinoin 0.025% cream

Participant Flow:   Overall Study
    Ziana Gel     Clindamycin Plus Tretinoin Applied Separately  
STARTED     13     13  
COMPLETED     9     13  
NOT COMPLETED     4     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
Ziana Gel Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
Clindamycin Plus Tretinoin Applied Separately Generic clindamycin 1% gel plus tretinoin 0.025% cream
Total Total of all reporting groups

Baseline Measures
    Ziana Gel     Clindamycin Plus Tretinoin Applied Separately     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     7     2     9  
Between 18 and 65 years     6     11     17  
>=65 years     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  20.1  
  ( 13 to 35 )  
  26.2  
  ( 15 to 40 )  
  23.1  
  ( 13 to 40 )  
Gender  
[units: participants]
     
Female     9     6     15  
Male     4     7     11  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
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1.  Primary:   Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne   [ Time Frame: 12 weeks ]

2.  Secondary:   The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count   [ Time Frame: Baseline to 12 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Steven Feldman, MD, PhD
Organization: Wake Forest University Health Sciences
phone: 336-716-3775
e-mail: sfeldman@wfubmc.edu


No publications provided


Responsible Party: Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier: NCT01047189     History of Changes
Other Study ID Numbers: 00007137
Study First Received: January 11, 2010
Results First Received: July 1, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration