Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study

NCT ID: NCT01930565

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications.However, previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis.

To compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind split-face clinical trial.

Conditions

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Acne Vulgaris

Keywords

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acne therapeutics clinical trial natural compound Lactobacillus fermented Chamaecypris obtuse tea tree oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LFCO application

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

Group Type EXPERIMENTAL

LFCO application

Intervention Type OTHER

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.

TTO application

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

Group Type ACTIVE_COMPARATOR

TTO application

Intervention Type OTHER

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.

Interventions

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LFCO application

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.

Intervention Type OTHER

TTO application

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.

Intervention Type OTHER

Other Intervention Names

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LFCO containg creams applied to acne lesions TTO containg creams applied to acne lesions

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dae Hun Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dae Hun Sun, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Department of Dermatology, Seoul National University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 22168326 (View on PubMed)

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.

Reference Type RESULT
PMID: 17314442 (View on PubMed)

Related Links

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Other Identifiers

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H-1209-069-427

Identifier Type: -

Identifier Source: org_study_id