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

Sponsor

Galderma Laboratorium GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01220102

Collaborator

(none)

3,113

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne	Drug: 0.1% adapalene/ 2.5% benzoyl peroxide

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 Design

Study Type:

Observational

Actual Enrollment :

3113 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

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

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"

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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