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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of inflammatory and non-inflammatory acne lesions
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: LFCO application (Other)
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
Intervention: TTO application (Other)
Outcomes
Primary Outcomes
Number of inflammatory and non-inflammatory acne lesions
Time Frame: 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 Outcomes
- Patient's subjective assessments for comfortableness & efficacy(8 weeks after baseline)
- Sebum secretion assessment(8 weeks after baseline)
- Histopathologic analysis(8 weeks after baseline)
- Adverse effects(8 weeks after baseline)
Investigators
Dae Hun Suh
Professor
Seoul National University Hospital