The Effect of Oral Hyaluronic Acid on the Skin

Bloomage Biotechnology

Status: Completed

Conditions: Healthy Japanese Subjects

Treatments: Dietary Supplement: Hyaluronic acid 50 mg/capsule; Dietary Supplement: Hyaluronic acid 75 mg/capsule; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05803083

HR-2023-BMB01

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Hyaluronic Acid 150 mg

Active Comparator group

Description:

Take 150 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: Hyaluronic acid 75 mg/capsule

Hyaluronic Acid 100 mg

Active Comparator group

Description:

Take 100 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: Hyaluronic acid 50 mg/capsule

Placebo

Placebo Comparator group

Description:

Take 0 mg/day of hyaluronic acid.

Treatment:

Dietary Supplement: Placebo