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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Other: LFCO application; Other: TTO application

• Registration Number: NCT01930565
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-22
• Last Update Submitted: 2013-08-22
• Study First Posted: 2013-08-29
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LFCO application	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.
TTO application	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

Primary Outcome Measures

Name	Time	Method
Number of inflammatory and non-inflammatory acne lesions	total 8 weeks after baseline	Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness \& safety of two botanical compounds

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Dermatology, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of