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A Novel Method to Improve Acne Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176955
First Posted: August 6, 2010
Last Update Posted: March 7, 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.
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
Results First Submitted: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Behavioral: Internet survey
Drug: Benzoyl peroxide 5% 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
No text entered.

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
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
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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
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 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      10 100.0%      10 100.0%      20 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.3  (1.49)   15.5  (2.22)   15.4  (1.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  80.0%      4  40.0%      12  60.0% 
Male      2  20.0%      6  60.0%      8  40.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures
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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 reported.   Anticipated Reporting Date:   No text entered.  

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 reported.   Anticipated Reporting Date:   No text entered.  


  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: Brad Yentzer
Organization: Wake Forest Baptist Medical Center
phone: 336-716-4735
e-mail: byentzer@wakehealth.edu



Responsible Party: Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01176955     History of Changes
Other Study ID Numbers: 8982
First Submitted: August 5, 2010
First Posted: August 6, 2010
Results First Submitted: July 1, 2011
Results First Posted: October 21, 2011
Last Update Posted: March 7, 2017