Long-term Study of Epiduo in Patients With Moderate to Severe Acne

NCT01618773 | Completed DMC

• 1 other identifier: ELANG
• Study Type: observational
• Target: 6,036
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

acne; Epiduo; adapalene/ benzoyl peroxide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Quality of Life

  at baseline and after 3 and 9 months of treatment

• Treatment adherence

  after 3 and 9 months of treatment

• Local Skin Irritations

  over 9 months

Interventions

0.1% adapalene / 2.5% benzoyl peroxide DRUG

topical application

Also known as: Epiduo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

About 6,650 patients with moderate to severe acne (Leeds grade 4-12)

You may qualify if:

• The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
• Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study

You may not qualify if:

• Pregnancy or breastfeeding
• Acne inversa
• Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
• Hypersensitivity to the drug or any of its ingredients
• If applicable, other restrictions outlined in the SPC of Epiduo

Sponsors & Collaborators

• Galderma Laboratorium GmbH: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Benzoyl Peroxide; Adapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Harald PM Gollnick, Prof. Dr.

  Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share