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

Acne Vulgaris Clinical Trial

— PUMP-it  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338544
• Other study ID #: PUMP-it
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: February 15, 2016
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Galderma Laboratorium GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1388
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 0.1% Adapalene / 2.5% Benzoyl peroxide
Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Laboratorium GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient-reported assessment	Patient-reported assessment of application and convenience of Epiduo PUMP	at follow-up	No
Secondary	Physician's assessment	Overall assessment of Epiduo PUMP	at follow-up	No
Secondary	Adherence	Patient-reported frequency of the application	at follow-up	No
Secondary	Dysmorphic concern	Assessment of patient's body beliefs using the dysmorphic concern questionnaire	at baseline	No
Secondary	Adverse drug reactions	Documentation of adverse drug reactions	at follow-up	Yes