NCT01220102

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,113

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

October 12, 2010

Last Update Submit

February 15, 2016

Conditions

Acne

Keywords

acneEpiduoadapalene/ benzoyl peroxide

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • local skin irritations

    over 12 weeks

  • treatment adherence

    at final examination after 12 weeks of treatment

Interventions

0.1% adapalene/ 2.5% benzoyl peroxideDRUG

topical application, once per day

Also known as: Epiduo

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from about 324 dermatology practices

You may qualify if:

  • The patient has been diagnosed with moderate inflammatory acne
  • Topical monotherapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study
  • The patient is aged between 12 and 20 years

You may not qualify if:

  • Pregnancy or breastfeeding
  • Hypersensitivity to the medication or any of the ingredients
  • Other contraindications mentioned in the Epiduo SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

AdapaleneBenzoyl PeroxideAdapalene, Benzoyl Peroxide Drug Combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesDrug CombinationsPharmaceutical 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

October 12, 2010

First Posted

October 13, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share