the Evaluation of the Efficacy of TCI66207 on the Skin.

Skin Diseases Clinical Trial

Official title:

Evaluation of Skin Efficacy of TCI66207

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143034
• Other study ID #: TSMH No.18-148-A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2021
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy volunteers aged above 20 years old

2. Subject has dull skin.

Exclusion Criteria:

1. .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).

2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.

3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.

4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.

5. Subjects who have large spots (area >3 square centimeter) or abnormal acne.

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Dietary Supplement:
• TCI66207 Essence
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
• Placebo Essence
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.

Locations

Country	Name	City	State
Taiwan	Research & Design Center, TCI CO., Ltd	Taipei	Neipu Township

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Subjects will be tested in the 4th week.
Primary	The change of skin elasticity	Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: µm penetration depth into the probe opening, expressed as curvesCorneometer® units 0-120	Subjects will be tested in the 4th week.
Primary	The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units	Subjects will be tested in the 4th week.
Primary	The change of skin collagen density	DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score	Subjects will be tested in the 4th week.
Primary	The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Subjects will be tested in the 4th week.
Primary	The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Subjects will be tested in the 4th week.