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Patient Education in Adherence on Acne (PEAce)

Primary Purpose

Acne

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard of care + supplementary education
Standard of care + additional visits
Standard of care
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acne

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Swan Lane Medical Centre
  • Burbage Surgery
  • South Axholme Practice
  • Dr Moss and Partners
  • Barlow Medical Centre
  • Leicester Terrace Health Care Centre
  • University of Nottingham Health Service
  • Rothwell and Desborough Healthcare Group
  • Albany House Medical Centre
  • Whitby Group Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard of care + supplementary education

Standard of care

Standard of care + additional visits

Arm Description

Subjects will receive supplementary patient educational material in addition to standard-of-care instructions.

Subjects will receive standard-of-care instructions only.

Subjects will receive standard-of-care instructions, and two additional clinical visits.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 26, 2014
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02307266
Brief Title
Patient Education in Adherence on Acne (PEAce)
Official Title
Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care + supplementary education
Arm Type
Experimental
Arm Description
Subjects will receive supplementary patient educational material in addition to standard-of-care instructions.
Arm Title
Standard of care
Arm Type
Experimental
Arm Description
Subjects will receive standard-of-care instructions only.
Arm Title
Standard of care + additional visits
Arm Type
Experimental
Arm Description
Subjects will receive standard-of-care instructions, and two additional clinical visits.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care + supplementary education
Intervention Type
Behavioral
Intervention Name(s)
Standard of care + additional visits
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects age of 12 years or older, With facial acne vulgaris that can be managed in primary care Exclusion Criteria: 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)
Facility Information:
Facility Name
Swan Lane Medical Centre
City
Bolton
Country
United Kingdom
Facility Name
Burbage Surgery
City
Burbage
Country
United Kingdom
Facility Name
South Axholme Practice
City
Epworth
Country
United Kingdom
Facility Name
Dr Moss and Partners
City
Harrogate
Country
United Kingdom
Facility Name
Barlow Medical Centre
City
Manchester
Country
United Kingdom
Facility Name
Leicester Terrace Health Care Centre
City
Northampton
Country
United Kingdom
Facility Name
University of Nottingham Health Service
City
Nottingham
Country
United Kingdom
Facility Name
Rothwell and Desborough Healthcare Group
City
Rothwell
Country
United Kingdom
Facility Name
Albany House Medical Centre
City
Wellingborough
Country
United Kingdom
Facility Name
Whitby Group Practice
City
Whitby
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29027127
Citation
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.
Results Reference
derived

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Patient Education in Adherence on Acne (PEAce)

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