A Novel Method to Improve Acne Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01176955
First received: August 5, 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: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Behavioral: Internet survey
Drug: Benzoyl peroxide 5% gel

  Participant Flow
  Hide Participant Flow

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
Internet Survey Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Control Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.

Participant Flow:   Overall Study
    Internet Survey     Control  
STARTED     10     10  
COMPLETED     7     8  
NOT COMPLETED     3     2  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Internet Survey Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
Control Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Internet Survey     Control     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     10     10     20  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  15.3  ± 1.49     15.5  ± 2.22     15.4  ± 1.85  
Gender  
[units: participants]
     
Female     8     4     12  
Male     2     6     8  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adherence to Study Medication   [ Time Frame: 12 weeks ]

2.  Secondary:   The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.   [ Time Frame: Baseline to 12 weeks ]

3.  Secondary:   The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.   [ Time Frame: Baseline to 12 weeks ]

4.  Secondary:   The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.   [ Time Frame: 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Brad Yentzer
Organization: Wake Forest Baptist Medical Center
phone: 336-716-4735
e-mail: byentzer@wakehealth.edu


No publications provided


Responsible Party: Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier: NCT01176955     History of Changes
Other Study ID Numbers: 8982
Study First Received: August 5, 2010
Results First Received: July 1, 2011
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board