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Completed

NCT Number: NCT02307266

Patient Education in Adherence on Acne (PEAce)

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Swan Lane Medical Centre, Bolton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard of care + supplementary education

Behavioral

Standard of care + additional visits

Behavioral

Standard of Care

Behavioral

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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