The Effect of Oral Hyaluronic Acid on the Skin

The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-

This clinical trial aims to clarify the effect of hyaluronic acid on skin conditions.

Study Overview

• Status: Completed
• Conditions: Healthy Japanese Subjects
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Hyaluronic acid 75 mg/capsule; Dietary supplement: Hyaluronic acid 50 mg/capsule

Detailed Description

In this study, investigators will evaluate the skin condition before and after the intervention. The groups to be compared are two different doses of hyaluronic and a placebo.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Taito-ku, Tokyo, Japan, 110-0015
      • Ueno Asagao Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Japanese women between 30 and 60 years of age at the time of obtaining consent to participate in the study.
2. Healthy individuals with no chronic physical diseases, including skin diseases.
3. Person with sagging, dry, or flaky skin.
4. Person who have been fully informed of the purpose and content of the study, have the capacity to consent, understand it well, and voluntarily volunteer to participate in the study, and are able to consent to participation in the study in writing.
5. Person who be able to come to the study site on the designated examination date and undergo the examination.
6. Person who are deemed suitable by the investigator to participate in the study.

Exclusion Criteria:

1. Those who currently suffer from some disease and are receiving drug treatment.
2. Patients with skin disease symptoms such as atopic dermatitis.
3. Patients who have scars or inflammation on the evaluation site.
4. Patients who have taken or applied drugs in the past month for the purpose of treatment of the disease (excluding those who have taken drugs for headache, menstrual cramps, common cold, etc.).
5. Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
6. Patients with comorbidities and serious history of gastrointestinal disorders.
7. Patients with severe anemia.
8. BMI of 30.0 kg/m2 or more.
9. Person who are allergic to any ingredient in the test food or who are at risk of developing serious allergic reactions to any other food or drug.
10. person is currently, or within the past 3 months has been, or will be during the study period, a habitual consumer of functional foods, health foods, or supplements containing active ingredients similar to those in the test food.
11. Currently, and within the past 3 months, those who have or will take functional foods, health foods, or supplements that claim to improve skin on a regular basis during the study period (consumption for the purpose of maintaining good health is acceptable).
12. Currently, or within the past 3 months, those who have a habit of continuously taking or applying drugs that are claimed to improve the skin.
13. Pregnant, lactating, or of child-bearing potential.
14. Patients whose daily alcohol consumption exceeds an average of 60g/day of pure alcohol equivalent.
15. Patient with mental disorders.
16. Persons with a smoking habit.
17. Those who may change their lifestyle during the examination period (e.g., work at night, travel for long periods of time, etc.).
18. Patient who may develop seasonal allergic symptoms such as hay fever and may use medicines during the study period.
19. Persons who will be extremely neglectful of their skin care.
20. Those who intentionally cannot refrain from being exposed to direct sunlight, such as sunburn, during the examination period.
21. Person with a history of cosmetic procedures or treatments on the evaluation site within the past 6 months.
22. Person with currently participating in another human clinical trial, or who have not yet completed 3 months of participation in another human clinical trial.
23. Person who are judged by the investigator to be inappropriate for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronic Acid 150 mg; Take 150 mg/day of hyaluronic acid.	Dietary supplement: Hyaluronic acid 75 mg/capsule; Take 2 capsules per day at any time.
Placebo Comparator: Placebo; Take 0 mg/day of hyaluronic acid.	Dietary supplement: Placebo; Take 2 capsules per day at any time.
Active Comparator: Hyaluronic Acid 100 mg; Take 100 mg/day of hyaluronic acid.	Dietary supplement: Hyaluronic acid 50 mg/capsule; Take 2 capsules per day at any time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline skin viscoelasticity	In skin viscoelasticity measurement using Cutometer MPA580®, skin displacement is measured by applying negative pressure to the skin through the opening of the probe and releasing the negative pressure. The higher the value, the greater the viscoelasticity. Measurement part：Measure the center of the left face, connecting the bottom of the earlobe and the edge of the lip. Accepted value：Measure the same place 5 times, and use the average of 3 measurements with the highest and lowest value data removed based on the R2 value. Analysis target value：R0, R2, R5, R7	Week0, 2, 4, 8 and week 4 after the end of intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline skin moisture content	Skin moisture content is evaluated by using a Corneometer CM825®t	Week0, 2, 4, 8 and week 4 after the end of intake
Change from baseline trans-epidermal water transpiration	Trans-epidermal water transpiration is evaluated by using Tewameter TM300®	Week0, 2, 4, 8 and week 4 after the end of intake
Change from baseline VISIA image	Analyze the following items are measured and simply by putting face into VISIA Evolution. Measurement points：Photograph the left face Analysis target value：Blemishes, Wrinkles, Texture. Pores, Ultraviolet Blemishes, Brown Blemishes, Red Areas, Porphyrin.Higher numbers for these items indicate more advanced aging. Gloss is measured by VISIA-CR.	week 0, 2, 4, 8 and week 4 after the end of intake
Change from baseline face visual evaluation	Face visual evaluation is measured by the dermatologist. Evaluation items：Cutaneous carpus, cutaneous groove, comprehensive evaluation Evaluation site：Evaluation centered on the left face, connecting the lower earlobe and the edge of the lip Evaluation method：Perform visual judgment using DermLite DL100 (J Hewitt Co., Ltd.) and microscope (KH-1300/HXG-2016Z/HIROX). There are 5 levels of evaluation, and judgment is made using the following criteria. -2 (Poor), -1 (Slightly Poor), 0 (Normal), 1 (Somewhat Good), 2 (Good) Time Frame: Week 0, 2, 4, 8 and week 4 after the end of intake	Week0, 2, 4, 8 and week 4 after the end of intake

Collaborators and Investigators

• Sponsor: Bloomage Biotechnology Corp., Ltd.
• Investigators: Study Chair: Atsushi Nakajima, MD, Ueno Asagao Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Skin; Hyaluronic Acid
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: HR-2023-BMB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be discussed among the research affiliates after the study is completed.

Drug and device information, study documents

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