NCT01618773

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,036 (actual)
• Sponsor: Galderma Laboratorium GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	0.1% adapalene / 2.5% benzoyl peroxide	topical application

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-06-13
• Last updated: 2016-02-17