Long-term Study of Epiduo in Patients With Moderate to Severe Acne (ELANG)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication|
- Severity of acne [ Time Frame: at baseline and after 3 and 9 months treatment ] [ Designated as safety issue: No ]Efficacy is assessed by change in severity of acne according to the Leeds revised grading system
- Quality of Life [ Time Frame: at baseline and after 3 and 9 months of treatment ] [ Designated as safety issue: No ]Quality of life is assessed using the Cardiff Acne Disability Index
- Treatment adherence [ Time Frame: after 3 and 9 months of treatment ] [ Designated as safety issue: No ]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"
- Local Skin Irritations [ Time Frame: over 9 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Drug: 0.1% adapalene / 2.5% benzoyl peroxide
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618773
|Principal Investigator:||Harald PM Gollnick, Prof. Dr.||Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie|