NCT05309161

Brief Summary

This study is to investigate the improveing effects of the Crassocephalum rebens extract on skin conditions in normal people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 3, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 16, 2022

Last Update Submit

August 1, 2022

Conditions

Outcome Measures

Primary Outcomes (18)

  • Measurement of skin hydration

    Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)

    Week 0

  • Measurement of skin hydration

    Corneometer CM825 is used to measure the moisture of upper cheek (unit: Corneometer® unit)

    Week 4

  • Measurement of skin brightness

    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

    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

    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

    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

    Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)

    Week 0

  • Measurement of skin spots

    Visia® skin analysis system is used to measure the skin spots of full face (unit: number of spots)

    Week 4

  • Measurement of collagen content

    DermaLab® Series SkinLab Combo (Cortex) is employed to measure skin collagen content of upper cheek (unit: collagen density)

    Week 0

  • Measurement of collagen content

    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

    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

    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

    Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)

    Week 0

  • Measurement of skin elasticity

    Cutometer® is used to measure the skin elasticity of upper cheek (unit: mm)

    Week 4

  • Measurement of skin wrinkles

    Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)

    Week 0

  • Measurement of skin wrinkles

    Visia® skin analysis system is used to measure the skin wrinkles of full face (unit: number of wrinkles)

    Weeks 4

  • Measurement of skin pores

    Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)

    Week 0

  • Measurement of skin pores

    Visia® skin analysis system is used to measure the skin spots of full face (unit: number of pores)

    Week 4

Study Arms (2)

A group (placebo)

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Crassocephalum rabens extract

B group (experimental)

ACTIVE COMPARATOR

Crassocephalum rabens extract

Dietary Supplement: Crassocephalum rabens extract

Interventions

dosage: a capsule (180 mg)/day; duration: 1 month

A group (placebo)B group (experimental)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 20 years
  • Healthy people

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy & Science

Tainan, 71710, Taiwan

Location

Study Officials

  • Chia-Hua Liang

    Department of Cosmetic Science, Chia Nan University of Pharmacy & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 4, 2022

Study Start

March 14, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 3, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations