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Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05988554
Recruitment Status : Completed
First Posted : August 14, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
TCI Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Skin Condition Dietary Supplement: Placebo sachet Dietary Supplement: Hibiscus sabdariffa extract and collagen products Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products
Actual Study Start Date : June 5, 2023
Actual Primary Completion Date : August 31, 2023
Actual Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
Drug Information available for: Collagen

Arms and Interventions
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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 Name: SPRING Collagen Powder


Outcome Measures
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Primary Outcome Measures :
  1. The change of skin collagen density [ Time Frame: Week 0, week 4, week 8 ]
    DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units

  2. The change of skin wrinkles [ Time Frame: Week 0, week 4, week 8 ]
    VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units

  3. The change of skin texture [ Time Frame: Week 0, week 4, week 8 ]
    VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

  4. The change of skin elasticity [ Time Frame: Week 0, week 4, week 8 ]
    SoftPlus was utilized to measure skin elasticity. Units: arbitrary units

  5. The change of skin moisture [ Time Frame: Week 0, week 4, week 8 ]
    Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120


Secondary Outcome Measures :
  1. The change of skin melanin index [ Time Frame: Week 0, week 4, week 8 ]
    Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units

  2. The change of skin L* value [ Time Frame: Week 0, week 4, week 8 ]
    Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100

  3. The change of transepidermal water loss (TEWL) [ Time Frame: Week 0, week 4, week 8 ]
    Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²

  4. The change of skin pores [ Time Frame: Week 0, week 4, week 8 ]
    VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units

  5. The change of skin spots [ Time Frame: Week 0, week 4, week 8 ]
    VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units


Other Outcome Measures:
  1. The change of self-assessment skin condition [ Time Frame: Week 0, week 4, week 8 ]
    A self-assessment questionnaire was collected to evaluate skin condition


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05988554


Locations
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Taiwan
Chia Nan University of Pharmacy ＆ Science
Tainan, Taiwan
Sponsors and Collaborators
TCI Co., Ltd.
Investigators
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Principal Investigator: Chia-Hua Liang Chia Nan University of Pharmacy ＆ Science
More Information
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Responsible Party: TCI Co., Ltd.
ClinicalTrials.gov Identifier: NCT05988554    
Other Study ID Numbers: 23-048-B
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases