The Effect of Oral Hyaluronic Acid on the Skin

NCT05803083 | Completed DMC

• 1 other identifier: HR-2023-BMB01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Japanese Subjects

Keywords

Hyaluronic Acid; Skin

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Change from baseline skin moisture content

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

• Change from baseline trans-epidermal water transpiration

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

• Change from baseline VISIA image

  week 0, 2, 4, 8 and week 4 after the end of intake

• Change from baseline face visual evaluation

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

Study Arms (3)

Hyaluronic Acid 150 mg

ACTIVE COMPARATOR

Take 150 mg/day of hyaluronic acid.

Dietary Supplement: Hyaluronic acid 75 mg/capsule

Hyaluronic Acid 100 mg

ACTIVE COMPARATOR

Take 100 mg/day of hyaluronic acid.

Dietary Supplement: Hyaluronic acid 50 mg/capsule

Placebo

PLACEBO COMPARATOR

Take 0 mg/day of hyaluronic acid.

Dietary Supplement: Placebo

Interventions

Hyaluronic acid 75 mg/capsule DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Hyaluronic Acid 150 mg

Hyaluronic acid 50 mg/capsule DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Hyaluronic Acid 100 mg

Placebo DIETARY_SUPPLEMENT

Take 2 capsules per day at any time.

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bloomage Biotechnology Corp., Ltd.: lead

Study Sites (1)

Ueno Asagao Clinic

Taito-ku, Tokyo, 110-0015, Japan

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Atsushi Nakajima, MD

  Ueno Asagao Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 7, 2023
• Study Start: February 6, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: February 6, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)