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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: 0.1% Adapalene / 2.5% Benzoyl peroxide

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1388

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

About 2000 patients aged ≥9 years with moderate to severe inflammatory acne

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of acne	Efficacy is assessed by change in severity of acne according to the Leeds revised grading system	at baseline and after up to 3 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported assessment	Patient-reported assessment of application and convenience of Epiduo PUMP	at follow-up
Physician's assessment	Overall assessment of Epiduo PUMP	at follow-up
Adherence	Patient-reported frequency of the application	at follow-up
Dysmorphic concern	Assessment of patient's body beliefs using the dysmorphic concern questionnaire	at baseline
Adverse drug reactions	Documentation of adverse drug reactions	at follow-up

Collaborators and Investigators

• Sponsor: Galderma Laboratorium GmbH
• Investigators: Principal Investigator: Uwe Gieler, Prof. M.D., Universitätsklinikum Giessen und Marburg GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 15, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Benzoyl Peroxide; Adapalene
• Other Study ID Numbers: PUMP-it

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO