Healthy Japanese SubjectsNCT05803083
The Effect of Oral Hyaluronic Acid on the Skin
A study testing Hyaluronic acid 75 mg/capsule and Hyaluronic acid 50 mg/capsule in people with Healthy Japanese Subjects, run by Bloomage Biotechnology Corp., Ltd. at 1 site in Japan.
Trial summary
This clinical trial aims to clarify the effect of hyaluronic acid on skin conditions. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Subjects
- What is being tested?
- Hyaluronic acid 75 mg/capsule and Hyaluronic acid 50 mg/capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 6 Feb 2023to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Healthy Japanese Subjects
- Being tested
- Hyaluronic acid 75 mg/capsule, Hyaluronic acid 50 mg/capsule, Placebo
- Keywords
- Hyaluronic Acid, Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid 75 mg/capsuleDietary supplement
Take 2 capsules per day at any time.
Hyaluronic acid 50 mg/capsuleDietary supplement
Take 2 capsules per day at any time.
PlaceboDietary supplement
Take 2 capsules per day at any time.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid 150 mg | Active comparator | Take 150 mg/day of hyaluronic acid. Receives: Dietary Supplement: Hyaluronic acid 75 mg/capsule |
| Hyaluronic Acid 100 mg | Active comparator | Take 100 mg/day of hyaluronic acid. Receives: Dietary Supplement: Hyaluronic acid 50 mg/capsule |
| Placebo | Placebo comparator | Take 0 mg/day of hyaluronic acid. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week0, 2, 4, 8 and week 4 after the end of intake
Secondary outcomes (4)
Change from baseline skin moisture content
Skin moisture content is evaluated by using a Corneometer CM825®t
Measured: 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®
Measured: 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.
Measured: 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
Measured: Week0, 2, 4, 8 and week 4 after the end of intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start6 Feb 2023
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloomage Biotechnology Corp., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atsushi Nakajima, MD, Study chair, Ueno Asagao Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803083
- Sponsor's protocol ID
- HR-2023-BMB01
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-
- ClinicalTrials.gov ID
- NCT05803083
- Acronym / sponsor ID
- HR-2023-BMB01
- Conditions
- Healthy Japanese Subjects
- Keywords
- Hyaluronic Acid, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bloomage Biotechnology Corp., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid 150 mg | Active comparator | Dietary Supplement: Hyaluronic acid 75 mg/capsuleTake 150 mg/day of hyaluronic acid. |
| Hyaluronic Acid 100 mg | Active comparator | Dietary Supplement: Hyaluronic acid 50 mg/capsuleTake 100 mg/day of hyaluronic acid. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake 0 mg/day of hyaluronic acid. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid 75 mg/capsuleTake 2 capsules per day at any time. | Dietary supplement | Hyaluronic Acid 150 mg |
| Hyaluronic acid 50 mg/capsuleTake 2 capsules per day at any time. | Dietary supplement | Hyaluronic Acid 100 mg |
| PlaceboTake 2 capsules per day at any time. | Dietary supplement | Placebo |
Primary outcome
Change from baseline skin viscoelasticity
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake
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
4 secondary outcomes
Change from baseline skin moisture content
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake
Change from baseline trans-epidermal water transpiration
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake
Change from baseline VISIA image
Time frame: week 0, 2, 4, 8 and week 4 after the end of intake
Change from baseline face visual evaluation
Time frame: Week0, 2, 4, 8 and week 4 after the end of intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atsushi Nakajima, MD study chair
Ueno Asagao Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid 75 mg/capsule and Hyaluronic acid 50 mg/capsule in people with Healthy Japanese Subjects, run by Bloomage Biotechnology Corp., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline skin viscoelasticity (time frame: Week0, 2, 4, 8 and week 4 after the end of intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.