Long-term Study of Epiduo in Patients With Moderate to Severe Acne (ELANG)

February 15, 2016 updated by: Galderma Laboratorium GmbH

Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication

This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.

The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.

Study Type

Observational

Enrollment (Actual)

6036

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

About 6,650 patients with moderate to severe acne (Leeds grade 4-12)

Description

Inclusion Criteria:

  • The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
  • Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study

Exclusion Criteria:

  • Use of Epiduo within 3 months prior to inclusion
  • Pregnancy or breastfeeding
  • Acne inversa
  • Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
  • Hypersensitivity to the drug or any of its ingredients
  • If applicable, other restrictions outlined in the SPC of Epiduo

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 3 and 9 months treatment
Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
at baseline and after 3 and 9 months treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: at baseline and after 3 and 9 months of treatment
Quality of life is assessed using the Cardiff Acne Disability Index
at baseline and after 3 and 9 months of treatment
Treatment adherence
Time Frame: after 3 and 9 months of treatment
Treatment adherence is assessed by the physician using a mini-questionnaire published by the international acne expert group "Global Alliance to Improve Outcomes in Acne"
after 3 and 9 months of treatment
Local Skin Irritations
Time Frame: over 9 months
over 9 months

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

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

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

  • ELANG

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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