NCT01930565

Brief Summary

In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO) Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

August 20, 2013

Last Update Submit

August 22, 2013

Conditions

Acne Vulgaris

Keywords

acnetherapeuticsclinical trialnatural compoundLactobacillus fermented Chamaecypris obtusetea tree oil

Outcome Measures

Primary Outcomes (1)

  • Number of inflammatory and non-inflammatory acne lesions

    Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness \& safety of two botanical compounds

    total 8 weeks after baseline

Secondary Outcomes (4)

  • Patient's subjective assessments for comfortableness & efficacy

    8 weeks after baseline

  • Sebum secretion assessment

    8 weeks after baseline

  • Histopathologic analysis

    8 weeks after baseline

  • Adverse effects

    8 weeks after baseline

Study Arms (2)

LFCO application

EXPERIMENTAL

We made LFCO application(Lactobacillus Fermented Chamaecypris obtusa) containing cream to one side of patients' face to monitor effectiveness and safety in acne treatment.

Other: LFCO application

TTO application

ACTIVE COMPARATOR

To compare effectiveness and safety of new LFCO, we applied existing TTO containing cream to the other side of face in the same patients

Other: TTO application

Interventions

LFCO applicationOTHER

Application of LFCO (Lactobacillus fermented Chamaecypris obtusa ) containing creams to one randomly selected face of patients to monitor its effectiveness and safety of acne treatments.

Also known as: LFCO containg creams applied to acne lesions
LFCO application
TTO applicationOTHER

Application of TTO (Tea tree oil) containing creams to the other side of face of patients to monitor its effectiveness and safe compared with LFCO.

Also known as: TTO containg creams applied to acne lesions
TTO application

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 19-45
  • active acne lesions in both sides of face
  • available during study periods

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)

Department of Dermatology, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (2)

  • Hayashi N, Kawashima M. Multicenter randomized controlled trial on combination therapy with 0.1% adapalene gel and oral antibiotics for acne vulgaris: comparison of the efficacy of adapalene gel alone and in combination with oral faropenem. J Dermatol. 2012 Jun;39(6):511-5. doi: 10.1111/j.1346-8138.2011.01450.x. Epub 2011 Dec 14.

    PMID: 22168326RESULT

  • Enshaieh S, Jooya A, Siadat AH, Iraji F. The efficacy of 5% topical tea tree oil gel in mild to moderate acne vulgaris: a randomized, double-blind placebo-controlled study. Indian J Dermatol Venereol Leprol. 2007 Jan-Feb;73(1):22-5. doi: 10.4103/0378-6323.30646.

    PMID: 17314442RESULT

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Dae Hun Sun, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 29, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

KR(1)