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

Completed

• Conditions: Acne Vulgaris

• Registration Number: NCT01618773
• Lead Sponsor: Galderma Laboratorium GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6036

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of acne	at baseline and after 3 and 9 months treatment	Efficacy is assessed by change in severity of acne according to the Leeds revised grading system

Secondary Outcome Measures

Name	Time	Method
Local Skin Irritations	over 9 months
Quality of Life	at baseline and after 3 and 9 months of treatment	Quality of life is assessed using the Cardiff Acne Disability Index
Treatment adherence	after 3 and 9 months of treatment	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"