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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LFCO application
TTO application
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, therapeutics, clinical trial, natural compound, Lactobacillus fermented Chamaecypris obtuse, tea tree oil

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Dermatology, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LFCO application

TTO application

Arm Description

We made LFCO application(Lactobacillus Fermented Chamaecypris obtusa) containing cream to one side of patients' face to monitor effectiveness and safety in acne treatment.

To compare effectiveness and safety of new LFCO, we applied existing TTO containing cream to the other side of face in the same patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2013
Last Updated
August 22, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01930565
Brief Title
Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, therapeutics, clinical trial, natural compound, Lactobacillus fermented Chamaecypris obtuse, tea tree oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFCO application
Arm Type
Experimental
Arm Description
We made LFCO application(Lactobacillus Fermented Chamaecypris obtusa) containing cream to one side of patients' face to monitor effectiveness and safety in acne treatment.
Arm Title
TTO application
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
LFCO application
Other Intervention Name(s)
LFCO containg creams applied to acne lesions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TTO application
Other Intervention Name(s)
TTO containg creams applied to acne lesions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of inflammatory and non-inflammatory acne lesions
Description
Compared to baseline, number inflammatory and non-inflammatory acne lesions were counted to check out the effectiveness & safety of two botanical compounds
Time Frame
total 8 weeks after baseline
Secondary Outcome Measure Information:
Title
Patient's subjective assessments for comfortableness & efficacy
Description
Patients are required to report subjective assessments for comfortableness & efficacy for two creams they used
Time Frame
8 weeks after baseline
Title
Sebum secretion assessment
Description
Patients' sebum secretion from face was measured by sebumeter to detect sebum secretion changes after applying two components.
Time Frame
8 weeks after baseline
Title
Histopathologic analysis
Description
changes of tissue after application of two creams
Time Frame
8 weeks after baseline
Title
Adverse effects
Description
patients' reportings for severe side effects after application of two creams was monitored.
Time Frame
8 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hun Sun, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Dermatology, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22168326
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. 2012 Jun;39(6):511-5. doi: 10.1111/j.1346-8138.2011.01450.x. Epub 2011 Dec 14.
Results Reference
result
PubMed Identifier
17314442
Citation
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. doi: 10.4103/0378-6323.30646.
Results Reference
result
Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
Description
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Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study

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