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Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

Primary Purpose

Skin Condition

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo sachet
Hibiscus sabdariffa extract and collagen products
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Condition

Eligibility Criteria

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

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 (> 3 hr/week) in the past 4 weeks. Constant drug use Students who are currently taking courses taught by the principal investigator of this trial.

Sites / Locations

  • Chia Nan University of Pharmacy ＆ Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo sachet

Hibiscus sabdariffa extract and collagen products

Arm Description

Outcomes

Primary Outcome Measures

The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin elasticity
SoftPlus was utilized to measure skin elasticity. Units: arbitrary units
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

Secondary Outcome Measures

The change of skin melanin index
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units

Full Information

First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05988554
Brief Title
Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products
Official Title
Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

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

5. Study Description

Brief Summary
To assess Hibiscus sabdariffa extract and collagen products on skin condition improvement

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo sachet
Arm Type
Placebo Comparator
Arm Title
Hibiscus sabdariffa extract and collagen products
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo sachet
Intervention Description
Consume 1 sachet daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Hibiscus sabdariffa extract and collagen products
Other Intervention Name(s)
SPRING Collagen Powder
Intervention Description
Consume 1 sachet daily
Primary Outcome Measure Information:
Title
The change of skin collagen density
Description
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin elasticity
Description
SoftPlus was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin moisture
Description
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
Week 0, week 4, week 8
Secondary Outcome Measure Information:
Title
The change of skin melanin index
Description
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin L* value
Description
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Time Frame
Week 0, week 4, week 8
Title
The change of transepidermal water loss (TEWL)
Description
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
Time Frame
Week 0, week 4, week 8
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Title
The change of skin spots
Description
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Time Frame
Week 0, week 4, week 8
Other Pre-specified Outcome Measures:
Title
The change of self-assessment skin condition
Description
A self-assessment questionnaire was collected to evaluate skin condition
Time Frame
Week 0, week 4, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 (> 3 hr/week) in the past 4 weeks. Constant drug use Students who are currently taking courses taught by the principal investigator of this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy ＆ Science
City
Tainan
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

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