Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

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

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo sachet; Dietary supplement: Hibiscus sabdariffa extract and collagen products

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo sachet	Dietary supplement: Placebo sachet; Consume 1 sachet daily
Experimental: Hibiscus sabdariffa extract and collagen products	Dietary supplement: Hibiscus sabdariffa extract and collagen products; Consume 1 sachet daily; Other Names: SPRING Collagen Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin collagen density	DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units	Week 0, week 4, week 8
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Week 0, week 4, week 8
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Week 0, week 4, week 8
The change of skin elasticity	SoftPlus was utilized to measure skin elasticity. Units: arbitrary units	Week 0, week 4, week 8
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Week 0, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units	Week 0, week 4, week 8
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Week 0, week 4, week 8
The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Week 0, week 4, week 8
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Week 0, week 4, week 8
The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Week 0, week 4, week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of self-assessment skin condition	A self-assessment questionnaire was collected to evaluate skin condition	Week 0, week 4, week 8

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 23-048-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No