Acne Vulgaris
Conditions
Keywords
acne, Epiduo, adapalene/ benzoyl peroxide
Brief summary
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.
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.
Interventions
topical application
Sponsors
Galderma Laboratorium GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of acne | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | at baseline and after 3 and 9 months of treatment | Quality of life is assessed using the Cardiff Acne Disability Index |
| Treatment adherence | 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 |
| Local Skin Irritations | over 9 months | — |
Outcome results
None listed