Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

NCT05988554 | Completed

• 1 other identifier: 23-048-B
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• The change of skin melanin index

  Week 0, week 4, week 8

• The change of skin L* value

  Week 0, week 4, week 8

• The change of transepidermal water loss (TEWL)

  Week 0, week 4, week 8

• The change of skin pores

  Week 0, week 4, week 8

• The change of skin spots

  Week 0, week 4, week 8

Other Outcomes (1)

• The change of self-assessment skin condition

  Week 0, week 4, week 8

Study Arms (2)

Placebo sachet

PLACEBO COMPARATOR

Dietary Supplement: Placebo sachet

Hibiscus sabdariffa extract and collagen products

EXPERIMENTAL

Dietary Supplement: Hibiscus sabdariffa extract and collagen products

Interventions

Placebo sachet DIETARY_SUPPLEMENT

Consume 1 sachet daily

Placebo sachet

Hibiscus sabdariffa extract and collagen products DIETARY_SUPPLEMENT

Consume 1 sachet daily

Also known as: SPRING Collagen Powder

Hibiscus sabdariffa extract and collagen products

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged above 20 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Chia-Hua Liang

  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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: June 5, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

TW (1)