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

Completed

• Conditions: Acne Vulgaris

• Registration Number: NCT02338544
• Lead Sponsor: Galderma Laboratorium GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1388

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of acne	at baseline and after up to 3 weeks of treatment	Efficacy is assessed by change in severity of acne according to the Leeds revised grading system

Secondary Outcome Measures

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