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

NCT ID: NCT01618773

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6036 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-09-30

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.

Conditions

Acne Vulgaris

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

0.1% adapalene / 2.5% benzoyl peroxide

topical application

Intervention Type: DRUG

Other Intervention Names

Epiduo

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma Laboratorium GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald PM Gollnick, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie

Other Identifiers

ELANG

Identifier Type: -

Identifier Source: org_study_id