Patient Education in Adherence on Acne (PEAce)

Phase 4

Completed

• Conditions: Acne

• Registration Number: NCT02307266
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-06-13
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-25
• Results First Posted: 2016-09-08
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Male or female subjects age of 12 years or older,
2. With facial acne vulgaris that can be managed in primary care

Exclusion Criteria

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study,
2. Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)	week 12	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.

Trial Locations

Locations (10)

Swan Lane Medical Centre; 🇬🇧 Bolton, United Kingdom

Burbage Surgery; 🇬🇧 Burbage, United Kingdom

South Axholme Practice; 🇬🇧 Epworth, United Kingdom

Dr Moss and Partners; 🇬🇧 Harrogate, United Kingdom

Barlow Medical Centre; 🇬🇧 Manchester, United Kingdom

Leicester Terrace Health Care Centre; 🇬🇧 Northampton, United Kingdom

University of Nottingham Health Service; 🇬🇧 Nottingham, United Kingdom

Rothwell and Desborough Healthcare Group; 🇬🇧 Rothwell, United Kingdom

Albany House Medical Centre; 🇬🇧 Wellingborough, United Kingdom

Whitby Group Practice; 🇬🇧 Whitby, United Kingdom