Efficacy Testing of Collagen and Zhuyin Drinks

Not Applicable

Completed

• Conditions: Skin Condition
• Interventions: Dietary Supplement: Collagen Cubilose Drink; Dietary Supplement: Placebo drink

• Registration Number: NCT04266405
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-12
• Study Start: 2020-03-09
• Primary Completion: 2020-07-31
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen and Zhuyin Drinks	Collagen Cubilose Drink	-
Placebo drink	Placebo drink	-

Primary Outcome Measures

Name	Time	Method
The change of skin wrinkles	Change from Baseline skin wrinkles at 4 weeks	VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
The change of skin moisture	Change from Baseline skin moisture at 4 weeks	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin collagen density	Change from Baseline skin collagen density at 4 weeks	DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:Intensity score
The change of skin brightness	Change from Baseline skin brightness at 4 weeks	Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units
The change of interleukin-6	Change from Baseline skin brightness at 4 weeks	Venous blood was sampled to measure concentrations of interleukin-6.
The change of Matrix metalloproteinase-1	Change from Baseline skin brightness at 4 weeks	Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .
The change of metallopeptidase inhibitor 1	Change from Baseline skin brightness at 4 weeks	Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.
The change of TEWL	Change from Baseline TEWL at 4 weeks	Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2
The change of interleukin-8	Change from Baseline skin brightness at 4 weeks	Venous blood was sampled to measure concentrations of interleukin-8.
The change of Tumor necrosis factor	Change from Baseline skin brightness at 4 weeks	Venous blood was sampled to measure concentrations of Tumor necrosis factor.

Secondary Outcome Measures

Name	Time	Method
The change of skin pores	Change from Baseline skin pores at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of skin texture	Change from Baseline skin texture at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin spots	Change from Baseline skin spots at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of red areas	Change from Baseline red areas at 4 weeks	VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units

Trial Locations

Locations (1)

Chia Nan University of Pharmacy ＆ Science; 🇨🇳 Tainan, Taiwan