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Dermatologists' Educational Demonstration for Epiduo Application

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ClinicalTrials.gov Identifier: NCT02192632
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Acne Local Adverse Effects Drug: Epiduo once daily with detailed instruction for how to apply it Drug: Epiduo- once daily, simple instruction for application Drug: BPO once daily Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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



Primary Outcome Measures :
  1. Percentile reduction of non-inflammatory & inflammatory acne lesions [ Time Frame: 12 weeks ]
    Measurement of decreases in both non-inflammatory & inflammatory acne lesions


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192632


Locations
Korea, Republic of
Dermatology, Seoul National University
Seoul, Joungro, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02192632     History of Changes
Other Study ID Numbers: ADP-BPO
1402-051-555 ( Registry Identifier: 1402-051-555 )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Adapalene, Benzoyl Peroxide Drug Combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents