Efficacy Testing of Crassocephalum Rabens Extract Capsules

August 1, 2022 updated by: Greenyn Biotechnology Co., Ltd.
This study is to investigate the improveing effects of the Crassocephalum rebens extract on skin conditions in normal people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 71710
        • Chia Nan University of Pharmacy & Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age over 20 years
  2. Healthy people

Exclusion Criteria:

  1. Non-volunteer
  2. Pregnant and lactating women
  3. Hypersensitivity to the assigned product
  4. Diagnosed with skin diseases, liver diseases, kinedy disease, and other severe diseases
  5. Cosmetic, drug, or food allergies
  6. Concurrent aesthetic treatments (e.g., intense pulse light, medical peelings, or laser therapy)
  7. Aceepted aesthetic treatments one month ago before the study
  8. Chronic sun exposure (over 3 hours/day)
  9. The members of the research team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: A group (placebo)
Placebo
Dietary supplement: Crassocephalum rabens extract
dosage: a capsule (180 mg)/day; duration: 1 month
ACTIVE_COMPARATOR: B group (experimental)
Crassocephalum rabens extract
Dietary supplement: Crassocephalum rabens extract
dosage: a capsule (180 mg)/day; duration: 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of skin hydration
Time Frame: Week 0
Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)
Week 0
Measurement of skin hydration
Time Frame: Week 4
Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)
Week 4
Measurement of skin brightness
Time Frame: Week 0
Chroma Meter MM500 is employed to measure the brightness of upper cheek (unit: L* value (L* range: 0-100)).
Week 0
Measurement of skin brightness
Time Frame: Week 4
Chroma Meter MM500 is employed to measure the brightness of upper cheek (unit: L* value (L* range: 0-100)).
Week 4
Measurement of skin texture
Time Frame: Week 0
Visia® skin analysis system is used to measure the skin texture of full face (unit: number of fine lines)
Week 0
Measurement of skin texture
Time Frame: Week 4
Visia® skin analysis system is used to measure the skin texture of full face (unit: number of fine lines)
Week 4
Measurement of skin spots
Time Frame: Week 0
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)
Week 0
Measurement of skin spots
Time Frame: Week 4
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)
Week 4
Measurement of collagen content
Time Frame: Week 0
DermaLab® Series SkinLab Combo (Cortex) is employed to measure skin collagen content of upper cheek (unit: collagen density)
Week 0
Measurement of collagen content
Time Frame: Week 4
DermaLab® Series SkinLab Combo (Cortex) is employed to measure skin collagen content of upper cheek (unit: collagen density)
Week 4
Measurement of Crow's feet
Time Frame: Week 0
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of Visia® skin analysis system is used to measure the skin spots of full face (unit: number of fine lines around eyes)
Week 0
Measurement of Crow's feet
Time Frame: Week 4
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of Visia® skin analysis system is used to measure the skin spots of full face (unit: number of fine lines around eyes)
Week 4
Measurement of skin elasticity
Time Frame: Week 0
Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)
Week 0
Measurement of skin elasticity
Time Frame: Week 4
Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)
Week 4
Measurement of skin wrinkles
Time Frame: Week 0
Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)
Week 0
Measurement of skin wrinkles
Time Frame: Weeks 4
Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)
Weeks 4
Measurement of skin pores
Time Frame: Week 0
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)
Week 0
Measurement of skin pores
Time Frame: Week 4
Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greenyn Biotechnology Co., Ltd.

Collaborators

Chia Nan University of Pharmacy ＆ Science

Investigators

  • Principal Investigator: Chia-Hua Liang, Department of Cosmetic Science, Chia Nan University of Pharmacy ＆ Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2022

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

June 30, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (ACTUAL)

April 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 21-129-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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