Patient Education in Adherence on Acne (PEAce)

February 16, 2021 updated by: Galderma R&D

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bolton, United Kingdom
        • Swan Lane Medical Centre
      • Burbage, United Kingdom
        • Burbage Surgery
      • Epworth, United Kingdom
        • South Axholme Practice
      • Harrogate, United Kingdom
        • Dr Moss and Partners
      • Manchester, United Kingdom
        • Barlow Medical Centre
      • Northampton, United Kingdom
        • Leicester Terrace Health Care Centre
      • Nottingham, United Kingdom
        • University of Nottingham Health Service
      • Rothwell, United Kingdom
        • Rothwell and Desborough Healthcare Group
      • Wellingborough, United Kingdom
        • Albany House Medical Centre
      • Whitby, United Kingdom
        • Whitby Group Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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)
Time Frame: 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.
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD.03.SPR.102710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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