Acne Vulgaris
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.
Sponsors
Galderma Laboratorium GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥9 years * The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12) * Chest/back affected allowed, but not required * 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
* Pregnancy or breastfeeding * Acne inversa * Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones * Hypersensitivity to the medication or any of the ingredients * Other contraindications mentioned in the Epiduo® SPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of acne | at baseline and after up to 3 weeks of treatment | Efficacy is assessed by change in severity of acne according to the Leeds revised grading system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported assessment | at follow-up | Patient-reported assessment of application and convenience of Epiduo PUMP |
| Physician's assessment | at follow-up | Overall assessment of Epiduo PUMP |
| Adherence | at follow-up | Patient-reported frequency of the application |
| Dysmorphic concern | at baseline | Assessment of patient's body beliefs using the dysmorphic concern questionnaire |
| Adverse drug reactions | at follow-up | Documentation of adverse drug reactions |
Outcome results
None listed