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Clinical Trials/NCT05803083
NCT05803083
Completed
Not Applicable

The Effect of Oral Hyaluronic Acid on the Skin-A Randomized-Blind, Placebo-Controlled Study-

Bloomage Biotechnology Corp., Ltd.1 site in 1 country36 target enrollmentStarted: February 6, 2023Last updated:
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ConditionsHealthy Japanese Subjects

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Bloomage Biotechnology Corp., Ltd.
Enrollment
36
Locations
1
Primary Endpoint
Change from baseline skin viscoelasticity
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
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

  • •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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from baseline face visual evaluation(Week0, 2, 4, 8 and week 4 after the end of intake)
  • 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)

Investigators

Sponsor
Bloomage Biotechnology Corp., Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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