Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% adapalene / 2.5% benzoyl peroxide | Drug | topical application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of acne | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Quality of life is assessed using the Cardiff Acne Disability Index | at baseline and after 3 and 9 months of treatment |
| Treatment adherence | 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" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
About 6,650 patients with moderate to severe acne (Leeds grade 4-12)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Harald PM Gollnick, Prof. Dr. | Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
| after 3 and 9 months of treatment |
| Local Skin Irritations | over 9 months |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |