Efficacy Testing of VeCollal Products

To assess VeCollal formula on skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo sachet; Dietary supplement: VeCollal sachet; Dietary supplement: Collagen sachet

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Hua Liang; Phone Number: 2441 +886-06-2661911; Email: tinna_ling@mail.cnu.edu.tw
• Study Contact Backup: Name: Ping Lin; Phone Number: +886-02-87977811; Email: candice.lin@tci-bio.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo sachet; consume 1 sachet per day	Dietary supplement: Placebo sachet; consume 1 sachet per day
Experimental: VeCollal sachet; consume 1 sachet per day	Dietary supplement: VeCollal sachet; consume 1 sachet per day
Active Comparator: Collagen sachet; consume 1 sachet per day	Dietary supplement: Collagen sachet; consume 1 sachet per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
The change of skin elasticity	SoftPlus was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Change from Baseline skin L* value at 8 weeks
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin moisture index at 8 weeks
The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Change from Baseline skin TEWL at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
The change of fasting blood glucose	Fasting venous blood was sampled to measure blood glucose	Change from Baseline blood glucose at 8 weeks
The change of blood lipid profiles (total cholesterol, triglyceride)	Fasting venous blood was sampled to measure blood lipid profiles	Change from Baseline blood lipid profiles at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 22-112-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No