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

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.

Completed

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% adapalene/ 2.5% benzoyl peroxide

Drug

topical application, once per day

Other names: Epiduo

Primary outcomes

Severity of acne

Time frame: at baseline and after 12 weeks of treatment

efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system

Secondary outcomes

local skin irritations

Time frame: over 12 weeks
treatment adherence

Time frame: at final examination after 12 weeks of treatment

treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"

Sponsors and collaborators

Lead sponsor

Galderma Laboratorium GmbH

Industry

Registry information

Official study title

Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne

Acronym: TEENA

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Oct 13, 2010
Registry last updated: Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed