Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

September 23, 2025 updated by: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

Evaluation of the Effects of a Dietary Supplement Containing a Full Range of Hyaluronic Acids in Healthy Female Subjects With Dry Facial Skin and Lips

This is a single center, double-blind, randomized, placebo-controlled study, performed on two parallel groups.

A total of 130 adult female subjects meeting specific inclusion/exclusion criteria will be included in order to have 120 subjects who complete the study at Day 98/Week 14.

Subjects will be randomly assigned to either the FS-HA oral supplementation group (60 subjects) or the placebo group (60 subjects).

The subjects should agree to attend a total of five (5) visits as follows:

  • a screening visit within 21 days prior to Day 1 (from Day -22 to Day -1);
  • a baseline visit (Day 1);
  • two (2) intermediate visits (Day 29 and Day 84);
  • a follow-up and end-of- study visit on Day 98.

The primary objective of this study is to evaluate the effects of an oral supplementation containing a FS-HA on facial skin hydration after 3 months of use, compared with Placebo.

The Secondary Objective(s) will evaluate the effects of an oral supplementation containing a FS-HA compared with Placebo on:

  • the hydration of the lips using corneometry;
  • the skin quality of the face using dermatological assessments and biophysical measurements (TEWL and Mexametry);
  • the quality/health and beauty of the lips using dermatological assessments and biophysical measurements (Mexametry);
  • the volume of the lips using image analysis;
  • to assess the persistence of the effects 2 weeks after discontinuation;
  • to assess the subject perceived efficacy and acceptability (subject self-assessment);
  • to evaluate the safety of the study products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06200
        • CPCAD Hôpital L'Archet 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
  2. Female subject;
  3. Subject aged 40 to 70 years inclusive at the time of signing the ICF;
  4. Subject with thin and dry lips;
  5. Subject with dry skin measured on the cheeks (corneometry < 50);
  6. Female subject of childbearing potential must use one of the reliable methods of contraception during the investigation and agree not to change it during the study;
  7. Subject willing and able to follow all the study procedures and restrictions and complete the whole study phase;
  8. Subject affiliated to a health social security system (according to French Law).

Exclusion Criteria:

  1. Female subject who is pregnant or who is breast feeding;
  2. Female subject of childbearing potential with positive urine pregnancy test at the study visit (Day 1);
  3. Women with a BMI ≤ 17 or ≥ 32 kg/cm²;
  4. Subject with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
  5. Presenting or having a history of eating disorder (e.g. anorexia, food allergy) or gastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactose intolerance;
  6. Subject with an history of sleeve or bypass
  7. Subject with current participation in any other interventional clinical study, based on interview of the subject;
  8. Subject with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
  9. Subject with skin abnormalities (e.g., scars, excessive hair, tattooing) or any dermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which could interfere with the study;
  10. Subject having applied any cosmetic product (care cream, lotion, body milk…) or drug on the face (except usual cleansing products) within one week before the study visit (Day 1);
  11. Subject impossible to contact in case of emergency;
  12. Subject who, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);
  13. Subject who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
  14. Subject who has been deprived of their freedom by administrative or legal decision, or who is under care of a guardian or legal guardianship, or subject hospitalized in a medical or social establishment for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
1 capsule of placebo per day
Experimental: HAFS Supplementation
Hyaluronic acid full spectrum daily supplementation
Dietary supplement: HAFS Supplementation
1 capsule of HAFS per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin hydration
Time Frame: Change from baseline to 3 months
Facial skin hydration (Corneometer)
Change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lip hydration
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Changes in lip hydration (Corneometer®)
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip color
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Changes in skin and lip color (Mexameter®)
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Lip volume
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Change from baseline in lip volume (LifeViz®)
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Skin barrier function
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

The measurement of the TEWL gives an indication of the integrity of the barrier function of the stratum corneum.

The TEWL will be measured on the face at each evaluation visit using a Vapometer SWL-2 (Delfin, technologies, Kuopio, Finland). This portable device contains moisture sensors in a closed chamber type probe. The conditions of a closed chamber are created by contact with the skin surface (surface of the chamber =1 cm²). The TEWL measurement is expressed in g/m²/h after a stabilization time of 10 to 20 seconds.
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of skin face
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

Scoring system for the assessment of the skin face

Skin dryness : 0= no dryness to 9= very dry skin Skin roughness : 0= no roughness to 9= severe roughness Skin evenness : 0= not even at all to 9= very even Skin suppleness : 0= not supple at all to 9= very supple skin Skin elasticity : 0= no elasticity at all to 9= maximal elasticity Skin firmness 0= no firm at all to 9= very firm Skin plumping 0= not plump at all to 9= very plump
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Dermatological assessment of lips
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

At each evaluation visit, the lip qualities will be assessed by the Investigator/evaluator using the following 6-point scoring system from 0 to 5.

Lips fullness 0= very thin to 5= very full Lips dryness 0= no dryness to 5= very dry lips Lips roughness 0= no roughness to 5= severe roughness
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Self assessment questionnaire
Time Frame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
  1. Evaluation of the skin face : wrinkle, hydration, firmness, softness, radiance, plump (scores from 0 (not) to 3 (high))
  2. Evaluation of the lips : hydration, volume, fine lines, color, gloss (scores from 0 being mild and 10 very strong)
  3. Evaluation of hair quality : volume, growth, loss, strength, radiance (scores from 0 (not) to 3 (high))
  4. Evaluation of the nail quality : strength, radiance, frailty, growth (scores from 0 (not) to 3 (high))
  5. Joint health
From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

July 3, 2025

Study Completion (Actual)

July 3, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-A01613-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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