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Completed

NCT Number: NCT01618773

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% adapalene / 2.5% benzoyl peroxide

Drug

topical application

Other names: Epiduo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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"

  3. Local Skin Irritations

    Time frame: over 9 months

Sponsors and collaborators

Lead sponsor

Galderma Laboratorium GmbH

Industry

Registry information

Official study title

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

Acronym: ELANG

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2012
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.