Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty

Skin Condition Clinical Trial

Official title:

Efficacy Testing of Chenopodium Formosanum Extracts on Skin Beauty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591352
• Other study ID #: 22-043-B
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess Chenopodium formosanum extracts on skin condition improvement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 30, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Healthy adults aged above 20 years old

Exclusion Criteria:

• Subject who is not willing to participate in this study.

• Patients with diseases of the skin, liver, kidney.

• Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.

• Female who is pregnant or nursing or planning to become pregnant during the course of the study.

• Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks.

• Constant drug use

• Students who are currently taking courses taught by the principal investigator of this trial.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Chenopodium formosanum extracts sachet
consume 1 sachet per day
• Placebo sachet
consume 1 sachet per day

Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of liver function biomarkers (AST, ALT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
Other	The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
Other	The change of self-assessment skin condition	A self-assessment questionnaire was collected to evaluate skin condition	Change from Baseline skin condition at 8 weeks
Primary	The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 8 weeks
Primary	The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 8 weeks
Primary	The change of skin collagen density	DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin collagen density at 8 weeks
Primary	The change of skin elasticity	Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
Secondary	The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 8 weeks
Secondary	The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Change from Baseline L* value at 8 weeks
Secondary	The change of skin erythema index	Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units	Change from Baseline skin erythema index at 8 weeks
Secondary	The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin moisture at 8 weeks
Secondary	The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Change from Baseline TEWL at 8 weeks
Secondary	The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Change from Baseline skin pores at 8 weeks
Secondary	The change of AGEs of blood	Fasting venous blood was sampled to measure concentrations of AGEs	Change from Baseline AGEs at 8 weeks