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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930565
• Other study ID #: H-1209-069-427
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: August 22, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• LFCO 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.
• TTO 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Dermatology, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Histopathologic analysis	changes of tissue after application of two creams	8 weeks after baseline	No
Secondary	Adverse effects	patients' reportings for severe side effects after application of two creams was monitored.	8 weeks after baseline	Yes

External Links

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