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Completed

NCT Number: NCT02338544

Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1% adapalene / 2.5% benzoyl peroxide

Drug

Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.

Other names: Epiduo(R) PUMP

Primary outcomes

  1. Severity of acne

    Time frame: 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 outcomes

  1. Patient-reported assessment

    Time frame: at follow-up

    Patient-reported assessment of application and convenience of Epiduo PUMP

  2. Physician's assessment

    Time frame: at follow-up

    Overall assessment of Epiduo PUMP

  3. Adherence

    Time frame: at follow-up

    Patient-reported frequency of the application

  4. Dysmorphic concern

    Time frame: at baseline

    Assessment of patient's body beliefs using the dysmorphic concern questionnaire

  5. Adverse drug reactions

    Time frame: at follow-up

    Documentation of adverse drug reactions

Sponsors and collaborators

Lead sponsor

Galderma Laboratorium GmbH

Industry

Registry information

Acronym: PUMP-it

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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