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

Galderma

Status: Completed

Conditions: Acne Vulgaris

Treatments: Drug: 0.1% adapalene / 2.5% benzoyl peroxide

Study type: Observational

Funder types: Industry

Identifiers

NCT01618773

ELANG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,036 patients

Sex: All

Volunteers: No Healthy Volunteers

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