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The purpose of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.
The objective of this observational study is to assess the efficacy of Epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. This non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with Epiduo in particular. In addition safety and local tolerability profile of Epiduo are to be assessed under marketed conditions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% adapalene/ 2.5% benzoyl peroxide | Drug | topical application, once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of acne | efficacy is assessed by change in severity of acne according to the Leeds revised acne grading system | at baseline and after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| local skin irritations | over 12 weeks | |
| treatment adherence | treatment adherence is assessed by the physician using a mini-questionnaire recently published by the international acne expert group "Global Alliance to Improve Outcomes in Acne" |
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Inclusion Criteria:
Exclusion Criteria:
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About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices
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| Name | Affiliation | Role |
|---|---|---|
| Harald PM Gollnick, Prof. Dr. | Universitätsklinikum Magdeburg A.ö.R Klinik für Dermatologie und Venerologie | Principal Investigator |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| 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 |
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| at final examination after 12 weeks of treatment |
| 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 |