Overview

This trial is active, not recruiting.

Conditions facial acne, local adverse effects
Treatments epiduo once daily with detailed instruction for how to apply it, epiduo- once daily, simple instruction for application, bpo once daily
Sponsor Seoul National University Hospital
Start date March 2014
End date September 2014
Trial size 65 participants
Trial identifier NCT02192632, 1402-051-555, ADP-BPO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
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
epiduo once daily with detailed instruction for how to apply it
(Experimental)
After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group
epiduo- once daily, simple instruction for application
(Placebo Comparator)
After randomly assigned to side of BPO application, patients apply BPO during 12 week
bpo once daily

Primary Outcomes

Measure
Percentile reduction of non-inflammatory & inflammatory acne lesions
time frame: 12 weeks

Secondary Outcomes

Measure
Total number of local irriation effect counts (erythema, scaling, dryness, itching)
time frame: 12 week

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.