Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne (TEENA)

February 15, 2016 updated by: Galderma Laboratorium GmbH

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at baseline and after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local skin irritations
Time Frame: over 12 weeks
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"
at final examination after 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma Laboratorium GmbH

Investigators

  • Principal Investigator: Harald PM Gollnick, Prof. Dr., Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEENA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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