CompletedNCT05803083Updated Feb 6, 2024

The Effect of Oral Hyaluronic Acid on the Skin

An interventional study of Hyaluronic acid 75 mg/capsule and Hyaluronic acid 50 mg/capsule in Healthy Japanese Subjects, sponsored by Bloomage Biotechnology Corp., Ltd.. Completed at 1 site in Japan. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Bloomage Biotechnology Corp., Ltd. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 30 Years to 60 Years
Sex: Female

Study summary

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

Read the 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.

Conditions studied

Healthy Japanese Subjects

Keywords

Hyaluronic Acid
Skin

In context

Lead sponsor

Bloomage Biotechnology Corp., Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 60 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Japanese women between 30 and 60 years of age at the time of obtaining consent to participate in the study.
Healthy individuals with no chronic physical diseases, including skin diseases.
Person with sagging, dry, or flaky skin.
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.
Person who be able to come to the study site on the designated examination date and undergo the examination.
Person who are deemed suitable by the investigator to participate in the study.

Exclusion criteria

Exclusion Criteria:

Those who currently suffer from some disease and are receiving drug treatment.
Patients with skin disease symptoms such as atopic dermatitis.
Patients who have scars or inflammation on the evaluation site.
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.).
Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
Patients with comorbidities and serious history of gastrointestinal disorders.
Patients with severe anemia.
BMI of 30.0 kg/m2 or more.
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.
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.
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).
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.
Pregnant, lactating, or of child-bearing potential.
Patients whose daily alcohol consumption exceeds an average of 60g/day of pure alcohol equivalent.
Patient with mental disorders.
Persons with a smoking habit.
Those who may change their lifestyle during the examination period (e.g., work at night, travel for long periods of time, etc.).
Patient who may develop seasonal allergic symptoms such as hay fever and may use medicines during the study period.
Persons who will be extremely neglectful of their skin care.
Those who intentionally cannot refrain from being exposed to direct sunlight, such as sunburn, during the examination period.
Person with a history of cosmetic procedures or treatments on the evaluation site within the past 6 months.
Person with currently participating in another human clinical trial, or who have not yet completed 3 months of participation in another human clinical trial.
Person who are judged by the investigator to be inappropriate for this study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 36 participants (actual)

Study arms

Active comparator
Hyaluronic Acid 150 mg
Take 150 mg/day of hyaluronic acid.
Dietary Supplement: Hyaluronic acid 75 mg/capsule
Active comparator
Hyaluronic Acid 100 mg
Take 100 mg/day of hyaluronic acid.
Dietary Supplement: Hyaluronic acid 50 mg/capsule
Placebo comparator
Placebo
Take 0 mg/day of hyaluronic acid.
Dietary Supplement: Placebo

Interventions

Dietary supplementHyaluronic acid 75 mg/capsule
Take 2 capsules per day at any time.
Dietary supplementHyaluronic acid 50 mg/capsule
Take 2 capsules per day at any time.
Dietary supplementPlacebo
Take 2 capsules per day at any time.

What researchers measure

Primary outcomes

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
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake

Secondary outcomes

Change from baseline skin moisture content
Skin moisture content is evaluated by using a Corneometer CM825®t
Time frame: 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®
Time frame: 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.
Time frame: 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
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No — Data sharing will be discussed among the research affiliates after the study is completed.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05803083
Lead sponsor: Bloomage Biotechnology Corp., Ltd.
Responsible party: Sponsor
First posted: Apr 7, 2023
Start date: Feb 6, 2023
Primary completion: Dec 25, 2023
Completion: Dec 25, 2023
Last update: Feb 6, 2024

Study contacts

Atsushi Nakajima, MD

study chair · Ueno Asagao Clinic

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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