Trial Outcomes & Findings for Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris (NCT NCT00696449)

Results Overview

Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15	15	15	16
Overall Study COMPLETED	12	9	14	13
Overall Study NOT COMPLETED	3	6	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Frequent Office Visits n=15 Participants 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 n=15 Participants 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 n=15 Participants 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 n=16 Participants 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 n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	16 Participants n=4 Participants	61 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	16 participants n=4 Participants	61 participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

Percentage of prescribed doses taken over the 12-week study period, as measured by a Medication Event Monitoring System (MEMS) cap

Outcome measures

Outcome measures
Measure	Frequent Office Visits n=15 Participants 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 n=15 Participants 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 n=15 Participants 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 n=16 Participants 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.
Adherence to Treatment	64 Percent of prescribed doses Interval 10.0 to 98.0	38 Percent of prescribed doses Interval 0.0 to 98.0	28 Percent of prescribed doses Interval 5.0 to 60.0	52 Percent of prescribed doses Interval 2.0 to 83.0

Adverse Events

Frequent Office Visits

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electronic Reminders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parental Reminders

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Feldman

Wake Forest University Health Sciences

Phone: 3367167740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place