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

Study Overview
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: LFCO application
* Other: TTO application


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFCO application<br>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<br>* 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.<br>* Other names: LFCO containg creams applied to acne lesions;|
| Active Comparator: TTO application<br>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<br>* 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.<br>* Other names: TTO containg creams applied to acne lesions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's subjective assessments for comfortableness & efficacy | Patients are required to report subjective assessments for comfortableness & efficacy for two creams they used | 8 weeks after baseline | 
| Sebum secretion assessment | Patients' sebum secretion from face was measured by sebumeter to detect sebum secretion changes after applying two components. | 8 weeks after baseline | 
| Histopathologic analysis | changes of tissue after application of two creams | 8 weeks after baseline | 
| Adverse effects | patients' reportings for severe side effects after application of two creams was monitored. | 8 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, therapeutics, clinical trial, natural compound, Lactobacillus fermented Chamaecypris obtuse, tea tree oil