Dermatologists' Educational Demonstration for Epiduo Application

Facial Acne Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192632
• Other study ID #: ADP-BPO
• Secondary ID: 1402-051-555
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: March 10, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Acne
• Local Adverse Effects

Intervention

Drug:
• Epiduo once daily with detailed instruction for how to apply it

• Epiduo- once daily, simple instruction for application

• BPO once daily

Locations

Country	Name	City	State
Korea, Republic of	Dermatology, Seoul National University	Seoul	Joungro

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentile reduction of non-inflammatory & inflammatory acne lesions	Measurement of decreases in both non-inflammatory & inflammatory acne lesions	12 weeks	Yes
Secondary	Total number of local irriation effect counts (erythema, scaling, dryness, itching)	Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)	12 week	Yes