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

Galderma

Status: Completed

Conditions: Acne Vulgaris

Treatments: Drug: 0.1% Adapalene / 2.5% Benzoyl peroxide

Study type: Observational

Funder types: Industry

Identifiers

NCT02338544

PUMP-it

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,388 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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