Patient Education in Adherence on Acne (PEAce)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.

Official Title
-----------------
Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics

Conditions
-----------------
Acne

Intervention / Treatment
-----------------
* Behavioral: Standard of care + supplementary education
* Behavioral: Standard of care + additional visits
* Behavioral: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects age of 12 years or older, With facial acne vulgaris that can be managed in primary care Exclusion Criteria: Female subjects who are pregnant, nursing or planning a pregnancy during the study, Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of care + supplementary education<br>Subjects will receive supplementary patient educational material in addition to standard-of-care instructions. | Behavioral: Standard of care + supplementary education<br> <br> |
| Experimental: Standard of care<br>Subjects will receive standard-of-care instructions only. | Behavioral: Standard of care<br> <br> |
| Experimental: Standard of care + additional visits<br>Subjects will receive standard-of-care instructions, and two additional clinical visits. | Behavioral: Standard of care + additional visits<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) | To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the worst-case population: Missing data were considered as non-adherence. | week 12 |