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

NCT01220102 — Completed, 3113 participants, Galderma Laboratorium GmbH
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Efficacy of Epiduo and Adherence of Patients Between 12 to 20 Years Using This Drug First Time in the Monotherapy of Moderate Inflammatory Acne

RegistryNCT01220102, acronym TEENA
StatusCompleted
Study typeObservational
Enrollment3113 (Actual)
SponsorGalderma Laboratorium GmbH (Industry)
ConditionsAcne
Interventions0.1% adapalene/ 2.5% benzoyl peroxide (Drug)
Datesstart 2010-05-01, primary completion 2010-11-01, completion 2010-11-01, first posted 2010-10-13, last updated 2016-02-17

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

  • 0.1% adapalene/ 2.5% benzoyl peroxide (Drug), also known as Epiduo: topical application, once per day

+Outcome measures

Primary outcomes

  • Severity of acne [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 [over 12 weeks]
  • treatment adherence [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"

+Eligibility

Sex: All, ages: 12 Years to 20 Years

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

+Investigators

My Notes