the Evaluation of the Efficacy of TCI66207 on the Skin.

NCT05143034 | Completed

• 1 other identifier: TSMH No.18-148-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

TCI66207 Essence

EXPERIMENTAL

Essence

Dietary Supplement: TCI66207 Essence

Placebo Essence

PLACEBO COMPARATOR

Dietary Supplement: Placebo Essence

Interventions

TCI66207 Essence DIETARY_SUPPLEMENT

Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.

TCI66207 Essence

Placebo Essence DIETARY_SUPPLEMENT

Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.

Placebo Essence

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged above 20 years old
• Subject has dull skin.

You may not qualify if:

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

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Research & Design Center, TCI CO., Ltd

Taipei, Neipu Township, 114, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Chia-Hua Liang, Ph.D

  Chia Nan University of Pharmacy ＆ Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: November 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 7, 2021

Record last verified: 2021-11

Locations

TW (1)