Dermatologists' Educational Demonstration for Epiduo Application

Not Applicable

Completed

• Conditions: Local Adverse Effects; Facial Acne
• Interventions: Drug: Epiduo- once daily, simple instruction for application; Drug: Epiduo once daily with detailed instruction for how to apply it; Drug: BPO once daily

• Registration Number: NCT02192632
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epiduo- drug insert only gruop	Epiduo- once daily, simple instruction for application	After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group
Epiduo- dermatologist's detailed instruction	Epiduo once daily with detailed instruction for how to apply it	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
BPO group	BPO once daily	After randomly assigned to side of BPO application, patients apply BPO during 12 week

Primary Outcome Measures

Name	Time	Method
Percentile reduction of non-inflammatory & inflammatory acne lesions	12 weeks	Measurement of decreases in both non-inflammatory \& inflammatory acne lesions

Secondary Outcome Measures

Name	Time	Method
Total number of local irriation effect counts (erythema, scaling, dryness, itching)	12 week	Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)

Trial Locations

Locations (1)

Dermatology, Seoul National University; 🇰🇷 Seoul, Joungro, Korea, Republic of