Clinical trial NCT00696449
Conditions: Acne Vulgaris
Sponsor: Wake Forest University
Start date: 2006-06-01; Completion date: 2009-10-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate potential differences between four treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%. Differin is approved by the Food and Drug Administration (FDA) to treat acne.

Detailed description:
Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel, 0.1%. The four intervention groups were designated according to follow-up strategies as follows:

* More frequent than normal office visits
* Electronic reminders (voice, e-mail, text messages)
* Parental involvement/intervention reminders
* No intervention or reminders

Arms: arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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.
Interventions: intervention 1: Adapalene intervention 2: frequent visits intervention 3: electronic reminder intervention 4: Parent reminder intervention 5: Standard of care
Intervention descriptions: intervention 1: All Subjects will treat the face once daily in the evening. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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.

Protocol documents: