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

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ClinicalTrials.gov Identifier: NCT01930565
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, 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.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: LFCO application Other: TTO application Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: LFCO containg creams applied to acne lesions

Active Comparator: 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
Other: 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.
Other Name: TTO containg creams applied to acne lesions




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Patient's subjective assessments for comfortableness & efficacy [ Time Frame: 8 weeks after baseline ]
    Patients are required to report subjective assessments for comfortableness & efficacy for two creams they used

  2. Sebum secretion assessment [ Time Frame: 8 weeks after baseline ]
    Patients' sebum secretion from face was measured by sebumeter to detect sebum secretion changes after applying two components.

  3. Histopathologic analysis [ Time Frame: 8 weeks after baseline ]
    changes of tissue after application of two creams

  4. Adverse effects [ Time Frame: 8 weeks after baseline ]
    patients' reportings for severe side effects after application of two creams was monitored.



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930565


Locations
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Korea, Republic of
Department of Dermatology, Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Dae Hun Sun, MD Seoul National University Hospital

Additional Information:
Publications of Results:
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Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01930565     History of Changes
Other Study ID Numbers: H-1209-069-427
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Keywords provided by Dae Hun Suh, Seoul National University Hospital:
acne
therapeutics
clinical trial
natural compound
Lactobacillus fermented Chamaecypris obtuse
tea tree oil
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tea Tree Oil
Anti-Infective Agents, Local
Anti-Infective Agents