Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

Skin Condition Clinical Trial

Official title:

Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988554
• Other study ID #: 23-048-B
• Status: Completed
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo sachet
Consume 1 sachet daily
• Hibiscus sabdariffa extract and collagen products
Consume 1 sachet daily

Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of self-assessment skin condition	A self-assessment questionnaire was collected to evaluate skin condition	Week 0, week 4, week 8
Primary	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
Primary	The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Week 0, week 4, week 8
Primary	The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Week 0, week 4, week 8
Primary	The change of skin elasticity	SoftPlus was utilized to measure skin elasticity. Units: arbitrary units	Week 0, week 4, week 8
Primary	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	The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units	Week 0, week 4, week 8
Secondary	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
Secondary	The change of transepidermal water loss (TEWL)	Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²	Week 0, week 4, week 8
Secondary	The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Week 0, week 4, week 8
Secondary	The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Week 0, week 4, week 8