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Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00696449
First received: June 9, 2008
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: February 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Investigator;   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: Adapalene
Behavioral: frequent visits
Behavioral: electronic reminder
Behavioral: Parent reminder
Behavioral: Standard of care

  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
Frequent Office Visits This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
Electronic Reminders This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
Parental Reminders In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
Standard of Care Control This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.

Participant Flow:   Overall Study
    Frequent Office Visits   Electronic Reminders   Parental Reminders   Standard of Care Control
STARTED   15   15   15   16 
COMPLETED   12   9   14   13 
NOT COMPLETED   3   6   1   3 



  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
Frequent Office Visits This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.
Electronic Reminders This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.
Parental Reminders In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.
Standard of Care Control This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.
Total Total of all reporting groups

Baseline Measures
   Frequent Office Visits   Electronic Reminders   Parental Reminders   Standard of Care Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   15   16   61 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      15 100.0%      15 100.0%      15 100.0%      16 100.0%      61 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      7  46.7%      8  53.3%      9  60.0%      10  62.5%      34  55.7% 
Male      8  53.3%      7  46.7%      6  40.0%      6  37.5%      27  44.3% 
Region of Enrollment 
[Units: Participants]
         
United States   15   15   15   16   61 


  Outcome Measures

1.  Primary:   Adherence to Treatment   [ Time Frame: 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
Organization: Wake Forest University Health Sciences
phone: 3367167740
e-mail: sfeldman@wakehealth.edu



Responsible Party: Steven R. Feldman, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00696449     History of Changes
Other Study ID Numbers: 00000406
31219
Study First Received: June 9, 2008
Results First Received: February 10, 2017
Last Updated: February 10, 2017