Efficacy Testing of Collagen and Zhuyin Drinks

• Sponsor: TCI Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04266405
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Skin Condition	Dietary Supplement: Placebo drink; Dietary Supplement: Collagen Cubilose Drink	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Single
• Primary Purpose: Other
• Official Title: Efficacy Testing of Collagen and Zhuyin Drinks
• Actual Study Start Date: Mar 9, 2020
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo drink	Dietary Supplement: Placebo drink; consume 1 bottle (50 mL) per day for 28 days
Experimental: Collagen and Zhuyin Drinks	Dietary Supplement: Collagen Cubilose Drink; consume 1 bottle (50 mL) per day for 28 days

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. The change of TEWL [Change from Baseline TEWL at 4 weeks]

   Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2

5. 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

6. The change of interleukin-6 [Change from Baseline skin brightness at 4 weeks]

   Venous blood was sampled to measure concentrations of interleukin-6.

7. The change of interleukin-8 [Change from Baseline skin brightness at 4 weeks]

   Venous blood was sampled to measure concentrations of interleukin-8.

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.

9. 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 .

10. 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.

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chia Nan University of Pharmacy ＆ Science	Tainan		Taiwan	71710

Sponsors and Collaborators

• TCI Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TCI Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04266405
• Other Study ID Numbers: 20-003-B
• First Posted: Feb 12, 2020
• Last Update Posted: Dec 11, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Diseases

Study Results

No Results Posted as of Dec 11, 2020