Patient Education in Adherence on Acne (PEAce)
Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics
1 other identifier
interventional
97
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
September 8, 2016
CompletedFebruary 18, 2021
July 1, 2016
7 months
November 26, 2014
June 13, 2016
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Standard of care + supplementary education
EXPERIMENTALSubjects will receive supplementary patient educational material in addition to standard-of-care instructions.
Standard of care
EXPERIMENTALSubjects will receive standard-of-care instructions only.
Standard of care + additional visits
EXPERIMENTALSubjects will receive standard-of-care instructions, and two additional clinical visits.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects age of 12 years or older,
- With facial acne vulgaris that can be managed in primary care
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (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
Related Publications (1)
Myhill T, Coulson W, Nixon P, Royal S, McCormack T, Kerrouche N. Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study. Dermatol Ther (Heidelb). 2017 Dec;7(4):515-524. doi: 10.1007/s13555-017-0203-4. Epub 2017 Oct 12.
PMID: 29027127DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gaëlle Charier
- Organization
- Galderma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 4, 2014
Study Start
November 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 18, 2021
Results First Posted
September 8, 2016
Record last verified: 2016-07