Efficacy Testing of Collagen Elixir

Not Applicable

Completed

• Conditions: Skin Condition
• Interventions: Dietary Supplement: Blank; Dietary Supplement: Collagen drink

• Registration Number: NCT04878536
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess Isagenix-Collagen Elixir on skin condition improvement

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Study Start: 2021-05-18
• Primary Completion: 2021-07-30
• Study Completion: 2021-10-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo drink	Blank	-
Collagen drink	Collagen drink	-

Primary Outcome Measures

Name	Time	Method
The change of MMP-1 of blood	Change from Baseline MMP-1 at 4 weeks	Venous blood was sampled to measure MMP-1
The change of skin collagen density	Change from Baseline skin collagen density at 4 weeks	DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of TIMP-1 of blood	Change from Baseline TIMP-1 at 4 weeks	Venous blood was sampled to measure TIMP-1
The change of skin wrinkles	Change from Baseline skin wrinkles at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin elasticity	Change from Baseline skin elasticity at 4 weeks	Soft Plus was utilized to measure skin elasticity. 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

Secondary Outcome Measures

Name	Time	Method
The change of f-thiols of blood	Change from Baseline f-thiols at 4 weeks	Venous blood was sampled to measure f-thiols
The change of MDA of blood	Change from Baseline MDA at 4 weeks	Venous blood was sampled to measure MDA
The change of IL-10 of blood	Change from Baseline IL-10 at 4 weeks	Venous blood was sampled to measure IL-10
The change of SOD-RBC of blood	Change from Baseline SOD-RBC at 4 weeks	Venous blood was sampled to measure SOD-RBC
The change of blood total antioxidant capacity (TAC)	Change from Baseline TAC at 4 weeks	Venous blood was sampled to measure concentrations of TAC
The change of skin melanin index	Change from Baseline skin melanin index at 4 weeks	Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
The change of skin L* value	Change from Baseline L* value at 4 weeks	Chroma Meter MM500 was utilized to measure skin L\* value. Units: arbitrary units, 0-100
The change of skin brown spots	Change from Baseline skin brown spots at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
The change of TNF-α of blood	Change from Baseline TNF-α at 4 weeks	Venous blood was sampled to measure TNF-α
The change of GST-RBC of blood	Change from Baseline GST-RBC at 4 weeks	Venous blood was sampled to measure GST-RBC
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 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 skin UV spots	Change from Baseline skin UV spots at 4 weeks	VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
The change of t-GSH of blood	Change from Baseline t-GSH at 4 weeks	Venous blood was sampled to measure t-GSH

Trial Locations

Locations (1)

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