Patient Education in Adherence on Acne (PEAce)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of care + supplementary education

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

Group Type EXPERIMENTAL

Standard of care + supplementary education

Intervention Type BEHAVIORAL

Standard of care

Subjects will receive standard-of-care instructions only.

Group Type EXPERIMENTAL

Standard of care

Intervention Type BEHAVIORAL

Standard of care + additional visits

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

Group Type EXPERIMENTAL

Standard of care + additional visits

Intervention Type BEHAVIORAL

Interventions

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Standard of care + supplementary education

Intervention Type BEHAVIORAL

Standard of care + additional visits

Intervention Type BEHAVIORAL

Standard of care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No