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

NCT ID: NCT02338544

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1388 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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0.1% Adapalene / 2.5% Benzoyl peroxide

Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.

Intervention Type DRUG

Other Intervention Names

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Epiduo(R) PUMP

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma Laboratorium GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uwe Gieler, Prof. M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Gießen und Marburg GmbH

Other Identifiers

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PUMP-it

Identifier Type: -

Identifier Source: org_study_id

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