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The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.
The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.
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 up to 3 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% Adapalene / 2.5% Benzoyl peroxide | Drug | Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump. |
|
| 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 up to 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported assessment | Patient-reported assessment of application and convenience of Epiduo PUMP | at follow-up |
| Physician's assessment | Overall assessment of Epiduo PUMP |
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Inclusion Criteria:
Exclusion Criteria:
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About 2000 patients aged ≥9 years with moderate to severe inflammatory acne
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Gieler, Prof. M.D. | Universitätsklinikum Gießen und Marburg GmbH | 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 |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| at follow-up |
| Adherence | Patient-reported frequency of the application | at follow-up |
| Dysmorphic concern | Assessment of patient's body beliefs using the dysmorphic concern questionnaire | at baseline |
| Adverse drug reactions | Documentation of adverse drug reactions | at follow-up |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |