Efficacy Testing of Collagen Elixir

Skin Condition Clinical Trial

Official title:

Efficacy Testing of Collagen Drink

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878536
• Other study ID #: 21-042-B
• Status: Completed
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: October 25, 2021

Study information

• Verified date: March 2022
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess Isagenix-Collagen Elixir on skin condition improvement

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

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, 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.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Collagen drink
Testing product
• Blank
Placebo drink

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of total cholesterol of blood	Venous blood was sampled to measure total cholesterol	Change from Baseline total cholesterol at 4 weeks
Other	The change of triglyceride of blood	Venous blood was sampled to measure triglyceride	Change from Baseline triglyceride at 4 weeks
Other	The change of SGOT of blood	Venous blood was sampled to measure SGOT	Change from Baseline SGOT at 4 weeks
Other	The change of SGPT of blood	Venous blood was sampled to measure SGPT	Change from Baseline SGPT at 4 weeks
Other	The change of BUN of blood	Venous blood was sampled to measure BUN	Change from Baseline BUN at 4 weeks
Other	The change of creatinine of blood	Venous blood was sampled to measure creatinine	Change from Baseline creatinine at 4 weeks
Other	The change of uric acid of blood	Venous blood was sampled to measure uric acid	Change from Baseline uric acid at 4 weeks
Primary	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
Primary	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
Primary	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
Primary	The change of skin elasticity	Soft Plus was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 4 weeks
Primary	The change of MMP-1 of blood	Venous blood was sampled to measure MMP-1	Change from Baseline MMP-1 at 4 weeks
Primary	The change of TIMP-1 of blood	Venous blood was sampled to measure TIMP-1	Change from Baseline TIMP-1 at 4 weeks
Secondary	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
Secondary	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
Secondary	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
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 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
Secondary	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
Secondary	The change of TNF-a of blood	Venous blood was sampled to measure TNF-a	Change from Baseline TNF-a at 4 weeks
Secondary	The change of IL-10 of blood	Venous blood was sampled to measure IL-10	Change from Baseline IL-10 at 4 weeks
Secondary	The change of SOD-RBC of blood	Venous blood was sampled to measure SOD-RBC	Change from Baseline SOD-RBC at 4 weeks
Secondary	The change of f-thiols of blood	Venous blood was sampled to measure f-thiols	Change from Baseline f-thiols at 4 weeks
Secondary	The change of t-GSH of blood	Venous blood was sampled to measure t-GSH	Change from Baseline t-GSH at 4 weeks
Secondary	The change of GST-RBC of blood	Venous blood was sampled to measure GST-RBC	Change from Baseline GST-RBC at 4 weeks
Secondary	The change of MDA of blood	Venous blood was sampled to measure MDA	Change from Baseline MDA at 4 weeks
Secondary	The change of blood total antioxidant capacity (TAC)	Venous blood was sampled to measure concentrations of TAC	Change from Baseline TAC at 4 weeks