Phase 4 N=97 Randomized Health Services Research

Patient Education in Adherence on Acne (PEAce)

Acne

Bottom Line

View on ClinicalTrials.gov: NCT02307266 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2016

Primary outcome: Primary: Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS) — 63.1; 56.5; 48.2 percentage of adherence — p=0.3165

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Standard of care + supplementary education (Behavioral); Standard of care + additional visits (Behavioral); Standard of care (Behavioral)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)	63.1; 56.5; 48.2	0.3165

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02307266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.