Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne

NCT ID: NCT01220102

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

3113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.

Detailed Description

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The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.

Conditions

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Acne

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

topical application, once per day

Intervention Type DRUG

Other Intervention Names

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Epiduo

Eligibility Criteria

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Inclusion Criteria

* The patient has been diagnosed with moderate inflammatory acne
* Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
* The patient is aged between 12 and 20 years

Exclusion Criteria

* Pregnancy or breastfeeding
* Hypersensitivity to the medication or any of the ingredients
* Other contraindications mentioned in the Epiduo SPC
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 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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Harald PM Gollnick, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie

Other Identifiers

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TEENA

Identifier Type: -

Identifier Source: org_study_id

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