Long-term Study of Epiduo in Patients With Moderate to Severe Acne

Study Overview
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Brief Summary
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This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.

Detailed Description
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This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions. The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.

Official Title
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Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication

Conditions
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Acne Vulgaris

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 to severe inflammatory acne (Leeds Grade 4-12) Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study Exclusion Criteria: Use of Epiduo within 3 months prior to inclusion Pregnancy or breastfeeding Acne inversa Acne with preferential manifestation of microcysts, macrocysts and macrocomedones Hypersensitivity to the drug or any of its ingredients If applicable, other restrictions outlined in the SPC of Epiduo
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|

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 grading system | at baseline and after 3 and 9 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life is assessed using the Cardiff Acne Disability Index | at baseline and after 3 and 9 months of treatment | 
| Treatment adherence | Treatment adherence is assessed by the physician using a mini-questionnaire published by the international acne expert group Global Alliance to Improve Outcomes in Acne | after 3 and 9 months of treatment | 
| Local Skin Irritations |  | over 9 months | 

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