The Effect of Oral Hyaluronic Acid on the Skin

Sponsor
Bloomage Biotechnology Corp., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05803083
Collaborator
(none)
66
1
3
7.8
8.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Hyaluronic acid 75 mg/capsule
  • Dietary Supplement: Hyaluronic acid 50 mg/capsule
  • Dietary Supplement: Placebo
N/A

Detailed Description

In this study, we 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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-
Actual Study Start Date :
Feb 6, 2023
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

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.

Placebo Comparator: Placebo

Take 0 mg/day of hyaluronic acid.

Dietary Supplement: Placebo
Take 2 capsules per day at any time.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline skin viscoelasticity [Week0, 2, 4, 8 and week 4 after the end of intake]

    Measured using a Cutometer MPA580®

Secondary Outcome Measures

  1. Change from baseline skin moisture content [Week0, 2, 4, 8 and week 4 after the end of intake]

    Skin moisture content is evaluated by using a Corneometer CM825®t

  2. Change from baseline trans-epidermal water transpiration [Week0, 2, 4, 8 and week 4 after the end of intake]

    Trans-epidermal water transpiration is evaluated by using Tewameter TM300®

  3. Change from baseline VISIA image [week 0, 2, 4, 8 and week 4 after the end of intake]

    VISIA image analysis is including spots, wrinkles, texture, pores, UV spots, brown spots, red areas, porphyrin and gloss. Evaluation except gloss is measured by VISIATM Evolution, gloss is measured by VISIA-CR

  4. Change from baseline face visual evaluation [Week0, 2, 4, 8 and week 4 after the end of intake]

    Face visual evaluation is measured by the dermatologist

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ueno Asagao Clinic Taito-ku Tokyo Japan 110-0015

Sponsors and Collaborators

  • Bloomage Biotechnology Corp., Ltd.

Investigators

  • Study Chair: Atsushi Nakajima, MD, Ueno Asagao Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bloomage Biotechnology Corp., Ltd.
ClinicalTrials.gov Identifier:
NCT05803083
Other Study ID Numbers:
  • HR-2023-BMB01
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bloomage Biotechnology Corp., Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023