NCT02192632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

July 14, 2014

Last Update Submit

March 10, 2015

Conditions

Facial AcneLocal Adverse Effects

Outcome Measures

Primary Outcomes (1)

  • Percentile reduction of non-inflammatory & inflammatory acne lesions

    Measurement of decreases in both non-inflammatory \& inflammatory acne lesions

    12 weeks

Secondary Outcomes (1)

  • Total number of local irriation effect counts (erythema, scaling, dryness, itching)

    12 week

Study Arms (3)

Epiduo- dermatologist's detailed instruction

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

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

Epiduo- drug insert only gruop

EXPERIMENTAL

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

BPO group

PLACEBO COMPARATOR

After randomly assigned to side of BPO application, patients apply BPO during 12 week

Drug: BPO once daily

Interventions

Epiduo once daily with detailed instruction for how to apply itDRUG
Epiduo- dermatologist's detailed instruction
Epiduo- once daily, simple instruction for applicationDRUG
Epiduo- drug insert only gruop
BPO once dailyDRUG
BPO group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology, Seoul National University

Seoul, Joungro, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 17, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

KR(1)