Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne

Study Overview
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Brief Summary
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The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.

Detailed Description
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The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire. 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 up to 3 months.

Official Title
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Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne

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: Age ≥9 years The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12) Chest/back affected allowed, but not required 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: Pregnancy or breastfeeding Acne inversa Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones 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: 9 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|Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.|

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 up to 3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported assessment | Patient-reported assessment of application and convenience of Epiduo PUMP | at follow-up | 
| Physician's assessment | Overall assessment of Epiduo PUMP | at follow-up | 
| Adherence | Patient-reported frequency of the application | at follow-up | 
| Dysmorphic concern | Assessment of patient's body beliefs using the dysmorphic concern questionnaire | at baseline | 
| Adverse drug reactions | Documentation of adverse drug reactions | at follow-up |