NCT00696449

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene	All Subjects will treat the face once daily in the evening.
BEHAVIORAL	frequent 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.
BEHAVIORAL	electronic reminder	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.
BEHAVIORAL	Parent reminder	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.
BEHAVIORAL	Standard of care	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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-05-01
• Completion: 2009-10-01
• First posted: 2008-06-12
• Last updated: 2018-09-10
• Results posted: 2017-03-30

Locations

1 site across 1 country: United States