0.1% adapalene / 2.5% benzoyl peroxide
Drugtopical application
Other names: Epiduo
NCT Number: NCT01618773
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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Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
topical application
Other names: Epiduo
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
Time frame: at baseline and after 3 and 9 months of treatment
Quality of life is assessed using the Cardiff Acne Disability Index
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"
Time frame: over 9 months
Galderma Laboratorium GmbH
Industry
Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
Acronym: ELANG
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.
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