Efficacy Testing of Collagen and Zhuyin Drinks

Skin Condition Clinical Trial

Official title:

Efficacy Testing of Collagen and Zhuyin Drinks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266405
• Other study ID #: 20-003-B
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess collagen and zhuyin drink on skin & body condition improvement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

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, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).

• 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 in the past 4 weeks.

• Vegetarian

• Subjects who have large spots (area >3 square centimeter) or abnormal acne.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo drink
consume 1 bottle (50 mL) per day for 28 days
• Collagen Cubilose Drink
consume 1 bottle (50 mL) per day for 28 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 4 weeks
Primary	The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 4 weeks
Primary	The change of skin collagen density	DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:Intensity score	Change from Baseline skin collagen density at 4 weeks
Primary	The change of TEWL	Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2	Change from Baseline TEWL at 4 weeks
Primary	The change of skin brightness	Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units	Change from Baseline skin brightness at 4 weeks
Primary	The change of interleukin-6	Venous blood was sampled to measure concentrations of interleukin-6.	Change from Baseline skin brightness at 4 weeks
Primary	The change of interleukin-8	Venous blood was sampled to measure concentrations of interleukin-8.	Change from Baseline skin brightness at 4 weeks
Primary	The change of Tumor necrosis factor	Venous blood was sampled to measure concentrations of Tumor necrosis factor.	Change from Baseline skin brightness at 4 weeks
Primary	The change of Matrix metalloproteinase-1	Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .	Change from Baseline skin brightness at 4 weeks
Primary	The change of metallopeptidase inhibitor 1	Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.	Change from Baseline skin brightness at 4 weeks
Secondary	The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 4 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 4 weeks
Secondary	The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Change from Baseline skin spots at 4 weeks
Secondary	The change of red areas	VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units	Change from Baseline red areas at 4 weeks