Dermatologists' Educational Demonstration for Epiduo Application

March 10, 2015 updated by: Dae Hun Suh, Seoul National University Hospital
The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Joungro
      • Seoul, Joungro, Korea, Republic of, 110-744
        • Dermatology, Seoul National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6
  • age: 18-40

Exclusion Criteria:

  • pregnancy
  • mental illness
  • intake of oral isotretinoin within 6 months
  • application of the other oral or topical acne medications
  • chemical peeling or light based treatments within 6 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epiduo- dermatologist's detailed instruction
After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist
Drug: Epiduo once daily with detailed instruction for how to apply it
Experimental: Epiduo- drug insert only gruop
After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group
Drug: Epiduo- once daily, simple instruction for application
Placebo Comparator: BPO group
After randomly assigned to side of BPO application, patients apply BPO during 12 week
Drug: BPO once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentile reduction of non-inflammatory & inflammatory acne lesions
Time Frame: 12 weeks
Measurement of decreases in both non-inflammatory & inflammatory acne lesions
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of local irriation effect counts (erythema, scaling, dryness, itching)
Time Frame: 12 week
Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADP-BPO
  • 1402-051-555 (Registry Identifier: 1402-051-555)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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