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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01220102
Acronym
TEENA
Enrollment
3113
Registered
2010-10-13
Start date
2010-05-31
Completion date
2010-11-30
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Keywords

acne, Epiduo, adapalene/ benzoyl peroxide

Brief 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.

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.

Interventions

DRUG0.1% adapalene/ 2.5% benzoyl peroxide

topical application, once per day

Sponsors

Galderma Laboratorium GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Severity of acneat baseline and after 12 weeks of treatmentefficacy is assessed by change in severity of acne according to the Leeds revised acne grading system

Secondary

MeasureTime frameDescription
local skin irritationsover 12 weeks
treatment adherenceat final examination after 12 weeks of treatmenttreatment 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026