Patient Education in Adherence on Acne (PEAce)

Galderma R&D97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Acne

Interventions

Standard of care + supplementary educationBEHAVIORAL

Standard of care + additional visitsBEHAVIORAL

Standard of careBEHAVIORAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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.

Time frame: week 12

Data from ClinicalTrials.gov

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