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

Seoul National University

Status: Completed

Conditions: Acne Vulgaris

Treatments: Other: TTO application; Other: LFCO application

Study type: Interventional

Funder types: Other

Identifiers

NCT01930565

H-1209-069-427

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

LFCO application

Experimental group

Description:

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

Treatment:

Other: LFCO application

TTO application

Active Comparator group

Description:

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

Treatment:

Other: TTO application