Patient Education on Acne (PEAce)
Research type
Research Study
Full title
Effect of Patient Education on Treatment Adherence and Satisfaction among Acne Patients Receiving Once-Daily EpiduoTM Gel Treatment in Primary Care Clinics
IRAS ID
162636
Contact name
Richard / M Falk
Contact email
Sponsor organisation
Galderma R&D SNC
Eudract number
2014-002509-39
Duration of Study in the UK
0 years, 7 months, 17 days
Research summary
Poor adherence to topical acne treatments is independently correlated with consultation with primary care physicians, lack of knowledge about the acne treatment and the occurrence of side effects. Therefore, the sponsor's hypothesis is that the adherence to once-daily, topical treatment of Epiduo (a fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5%), can be improved by a supplementary patient education intervention, which provides information about the mode of action of the medication, the method of application, when improvement is expected, and how to manage irritation when it occurs.
A total of 90 subjects (30 per group)will be enrolled at approximately 10 primary care sites in the UK. The main inclusion criteria are male or female acne vulgaris subjects, age of 12 years or older, meeting specific inclusion/exclusion criteria.
Patients will be randomly assigned into one of the three groups by chance to receive different education intervention and/or visit schedules. Regardless of the group they are assigned to, they will receive the active treatment for their acne (EpiduoTM). The participation in the study will last 12 weeks, with a total of 3 or 5 visits at the study site depending on their group.
The study is organized and funded by GALDERMA Research& Development and will be monitored by Chiltern International.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1172
Date of REC Opinion
30 Oct 2014
REC opinion
Further Information Favourable Opinion