Clinical trial NCT05803083: The Effect of Oral Hyaluronic Acid on the Skin
Official title: The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Japanese Subjects
Keywords: Hyaluronic Acid
Skin
Lead sponsor: Bloomage Biotechnology Corp., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 36
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline skin viscoelasticity
timeFrame: Week0, 2, 4, 8 and week 4 after the end of intake
Secondary outcomes:
measure: Change from baseline skin moisture content
timeFrame: Week0, 2, 4, 8 and week 4 after the end of intake
measure: Change from baseline trans-epidermal water transpiration
timeFrame: Week0, 2, 4, 8 and week 4 after the end of intake
measure: Change from baseline VISIA image
timeFrame: week 0, 2, 4, 8 and week 4 after the end of intake
measure: Change from baseline face visual evaluation
timeFrame: Week0, 2, 4, 8 and week 4 after the end of intake
Other outcomes:
Locations:
city: Taito-ku
country: Japan
facility: Ueno Asagao Clinic
state: Tokyo
Study officials:
affiliation: Ueno Asagao Clinic
name: Atsushi Nakajima, MD
role: STUDY_CHAIR
References: