Acne Vulgaris
Conditions
Keywords
acne, therapeutics, clinical trial, natural compound, Lactobacillus fermented Chamaecypris obtuse, tea tree oil
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.
Interventions
OTHERLFCO application
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.
OTHERTTO application
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed