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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acne

Intervention / Treatment
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* Drug: 0.1% adapalene/ 2.5% benzoyl peroxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 0.1% adapalene/ 2.5% benzoyl peroxide|topical application, once per day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of acne | efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system | at baseline and after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local skin irritations |  | over 12 weeks | 
| treatment adherence | 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 | at final examination after 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, Epiduo, adapalene/ benzoyl peroxide