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Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition

Primary Purpose

Skin Condition

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
placebo group
collagen drinkss
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Condition

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Dry skin
  2. Rough skin
  3. Large pores
  4. Dark yellow complexion
  5. Sagging skin

Exclusion Criteria:

  1. Skin disorders
  2. Liver diseases
  3. Kidney diseases
  4. Allergy to cosmetics, drugs, or foods
  5. Pregnant and lactating women
  6. People who had any cosmetic procedures before 4 weeks of the study
  7. Area of facial spot over 3 cm2
  8. Vegan
  9. People who took collagen supplements in the past 3 months.

Sites / Locations

  • Research & Design Center, TCI CO., Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo group

collagen drinks

Arm Description

subjects drank 50 ml every night for 14, 28 days

subjects drank 50 ml every night for 14, 28 days

Outcomes

Primary Outcome Measures

skin moisture
using corneometer CM825 to examine skin moisture (The higher the value, the more water content, C.U., corneometer units )
skin elasticity
using cutometer dual MPA580 to examine skin elasticity (The closer the R2 value is to 1, the better the elasticity and no unit)
skin gloss
using probe system GL2000 & MPA10 to examine skin gloss (The higher the value, the higher the gloss, no unit)
skin spot
usig VISIA-CR to examine skin spot (The higher the value, the larger the pore area, mm2)
skin wrinkle
using VISIOSCAN-VC20 to examine skin wrinkle (The higher the value, the more wrinkles, surface evaluation of wrinkles, SEW)
skin roughness
using VISIOSCAN-VC98 to examine skin roughness (The higher the value, the higher the roughness, surface evaluation of roughness, SEr)
skin smoothness
using VISIOSCAN-VC98 to examine skin smoothness (The lower the value, the higher the smoothness, surface evaluation of smoothness, SEsm)

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
January 12, 2021
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04709588
Brief Title
Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
Official Title
Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Collagen combined with djulis and green caviar improve skin condition
Detailed Description
Using collagen drinks combined fish collagen with djulis, and green caviar to improve skin condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
subjects drank 50 ml every night for 14, 28 days
Arm Title
collagen drinks
Arm Type
Experimental
Arm Description
subjects drank 50 ml every night for 14, 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo group
Intervention Description
subjects drank 50 ml every night for 14, 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
collagen drinkss
Intervention Description
subjects drank 50 ml every night for 14, 28 days
Primary Outcome Measure Information:
Title
skin moisture
Description
using corneometer CM825 to examine skin moisture (The higher the value, the more water content, C.U., corneometer units )
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin elasticity
Description
using cutometer dual MPA580 to examine skin elasticity (The closer the R2 value is to 1, the better the elasticity and no unit)
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin gloss
Description
using probe system GL2000 & MPA10 to examine skin gloss (The higher the value, the higher the gloss, no unit)
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin spot
Description
usig VISIA-CR to examine skin spot (The higher the value, the larger the pore area, mm2)
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin wrinkle
Description
using VISIOSCAN-VC20 to examine skin wrinkle (The higher the value, the more wrinkles, surface evaluation of wrinkles, SEW)
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin roughness
Description
using VISIOSCAN-VC98 to examine skin roughness (The higher the value, the higher the roughness, surface evaluation of roughness, SEr)
Time Frame
subjects drank 50 ml every night for 28 days
Title
skin smoothness
Description
using VISIOSCAN-VC98 to examine skin smoothness (The lower the value, the higher the smoothness, surface evaluation of smoothness, SEsm)
Time Frame
subjects drank 50 ml every night for 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Dry skin Rough skin Large pores Dark yellow complexion Sagging skin Exclusion Criteria: Skin disorders Liver diseases Kidney diseases Allergy to cosmetics, drugs, or foods Pregnant and lactating women People who had any cosmetic procedures before 4 weeks of the study Area of facial spot over 3 cm2 Vegan People who took collagen supplements in the past 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Fu Chiang, Ph.D
Organizational Affiliation
Research & Design Center, TCI CO., Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research & Design Center, TCI CO., Ltd
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydrolyzed Collagen Combined With Djulis and Green Caviar Improve Skin Condition

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