Efficacy Testing of Collagen Peptide Drink

To assess Collagen Peptide Drink on skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo drink; Dietary supplement: Collagen Peptide Drink

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

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: No
• Genders Eligible for Study: All

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 in the past 4 weeks.
• Constant drug use
• Participated cosmetic product human study in the past 3 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo drink	Dietary supplement: Placebo drink; Blank
Experimental: Collagen Peptide Drink	Dietary supplement: Collagen Peptide Drink; Testing product; Other Names: Pearlosophy-Collagen Peptide Drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 4 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 4 weeks
The change of skin elasticity	Soft Plus was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 4 weeks
The change of MMP-1 of blood	Venous blood was sampled to measure MMP-1	Change from Baseline MMP-1 at 4 weeks
The change of TIMP-1 of blood	Venous blood was sampled to measure TIMP-1	Change from Baseline TIMP-1 at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The change of skin melanin index	Soft Plus was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 4 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 L* value at 4 weeks
The change of skin UV spots	VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units	Change from Baseline skin UV spots at 4 weeks
The change of skin brown spots	VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units	Change from Baseline skin brown spots at 4 weeks
The change of TNF-α of blood	Venous blood was sampled to measure TNF-α	Change from Baseline TNF-α at 4 weeks
The change of IL-10 of blood	Venous blood was sampled to measure IL-10	Change from Baseline IL-10 at 4 weeks
The change of SOD-RBC of blood	Venous blood was sampled to measure SOD-RBC	Change from Baseline SOD-RBC at 4 weeks
The change of f-thiols of blood	Venous blood was sampled to measure f-thiols	Change from Baseline f-thiols at 4 weeks
The change of t-GSH of blood	Venous blood was sampled to measure t-GSH	Change from Baseline t-GSH at 4 weeks
The change of GST-RBC of blood	Venous blood was sampled to measure GST-RBC	Change from Baseline GST-RBC at 4 weeks
The change of MDA of blood	Venous blood was sampled to measure MDA	Change from Baseline MDA at 4 weeks
The change of blood total antioxidant capacity (TAC)	Venous blood was sampled to measure concentrations of TAC	Change from Baseline TAC at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of total cholesterol of blood	Venous blood was sampled to measure total cholesterol	Change from Baseline total cholesterol at 4 weeks
The change of triglyceride of blood	Venous blood was sampled to measure triglyceride	Change from Baseline triglyceride at 4 weeks
The change of SGOT of blood	Venous blood was sampled to measure SGOT	Change from Baseline SGOT at 4 weeks
The change of SGPT of blood	Venous blood was sampled to measure SGPT	Change from Baseline SGPT at 4 weeks
The change of BUN of blood	Venous blood was sampled to measure BUN	Change from Baseline BUN at 4 weeks
The change of creatinine of blood	Venous blood was sampled to measure creatinine	Change from Baseline creatinine at 4 weeks
The change of uric acid of blood	Venous blood was sampled to measure uric acid	Change from Baseline uric acid at 4 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): May 17, 2021
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 21-042-B2

Drug and device information, study documents

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