Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne

Completed

• Conditions: Acne

• Registration Number: NCT01220102
• Lead Sponsor: Galderma Laboratorium GmbH

Brief Summary

The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.

Detailed Description

The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3113

Inclusion Criteria

• The patient has been diagnosed with moderate inflammatory acne
• Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
• The patient is aged between 12 and 20 years

Exclusion Criteria

• Pregnancy or breastfeeding
• Hypersensitivity to the medication or any of the ingredients
• Other contraindications mentioned in the Epiduo SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of acne	at baseline and after 12 weeks of treatment	efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system

Secondary Outcome Measures

Name	Time	Method
local skin irritations	over 12 weeks
treatment adherence	at final examination after 12 weeks of treatment	treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"