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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220102
Other study ID # TEENA
Secondary ID
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


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
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