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

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ClinicalTrials.gov Identifier: NCT00696449
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : March 30, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Adapalene
Behavioral: frequent visits
Behavioral: electronic reminder
Behavioral: Parent reminder
Behavioral: Standard of care
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 15 15 15 16
Completed 12 9 14 13
Not Completed 3 6 1 3
Arm/Group Title Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 15 15 15 16 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 15 participants 16 participants 61 participants
15 15 15 16 61
1.Primary Outcome
Title Adherence to Treatment
Hide Description Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 15 15 15 16
Median (Full Range)
Unit of Measure: Percent of prescribed doses
64
(10 to 98)
38
(0 to 98)
28
(5 to 60)
52
(2 to 83)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Frequent Office Visits Electronic Reminders Parental Reminders Standard of Care Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/16 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Steven Feldman
Organization: Wake Forest University Health Sciences
Phone: 3367167740
EMail: sfeldman@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00696449    
Other Study ID Numbers: IRB00000406
31219
First Submitted: June 9, 2008
First Posted: June 12, 2008
Results First Submitted: February 10, 2017
Results First Posted: March 30, 2017
Last Update Posted: September 10, 2018