NCT02338544

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

8 months

First QC Date

January 12, 2015

Last Update Submit

February 15, 2016

Conditions

Acne Vulgaris

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 up to 3 weeks of treatment

Secondary Outcomes (5)

  • Patient-reported assessment

    at follow-up

  • Physician's assessment

    at follow-up

  • Adherence

    at follow-up

  • Dysmorphic concern

    at baseline

  • Adverse drug reactions

    at follow-up

Interventions

0.1% Adapalene / 2.5% Benzoyl peroxideDRUG

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

Also known as: Epiduo(R) PUMP

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

About 2000 patients aged ≥9 years with moderate to severe inflammatory acne

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

AdapaleneBenzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene Derivatives

Study Officials

  • Uwe Gieler, Prof. M.D.

    Universitätsklinikum Gießen und Marburg GmbH

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share