Clinical trial NCT01930565: Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study
Official title: Comparison of Clinical and Histological Effects Between Lactobacillus Fermented Chamaecypris Obtusa and Tea Tree Oil for the Treatment of Mild to Moderate Acne: an 8-week Double Blind, Randomized Controlled, Split-face Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne
therapeutics
clinical trial
natural compound
Lactobacillus fermented Chamaecypris obtuse
tea tree oil
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of inflammatory and non-inflammatory acne lesions
timeFrame: total 8 weeks after baseline
Secondary outcomes:
measure: Patient's subjective assessments for comfortableness & efficacy
timeFrame: 8 weeks after baseline
measure: Sebum secretion assessment
timeFrame: 8 weeks after baseline
measure: Histopathologic analysis
timeFrame: 8 weeks after baseline
measure: Adverse effects
timeFrame: 8 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University College of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Dae Hun Sun, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.