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

Acne Clinical Trial

— TEENA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220102
• Other study ID #: TEENA
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: February 15, 2016
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2016
• Source: Galderma Laboratorium GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3113
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 20 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• 0.1% adapalene/ 2.5% benzoyl peroxide
topical application, once per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma Laboratorium GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of acne	efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system	at baseline and after 12 weeks of treatment	No
Secondary	local skin irritations		over 12 weeks	Yes
Secondary	treatment adherence	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"	at final examination after 12 weeks of treatment	No