Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

Last updated: January 8, 2025
Sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

HAFS Supplementation

Placebo

Clinical Study ID

NCT06774742
2024-A01613-44
  • Ages 40-70
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject having signed an Informed Consent Form (ICF) before any trial relatedactivity 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 ofcontraception 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 andcomplete the whole study phase;

  8. Subject affiliated to a health social security system (according to French Law).

Exclusion

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 thestudy 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) orgastro-intestinal malabsorption such as celiac disease, Crohn's disease, lactoseintolerance;

  6. Subject with an history of sleeve or bypass

  7. Subject with current participation in any other interventional clinical study, basedon interview of the subject;

  8. Subject with known or suspected hypersensitivity to any component(s) of theinvestigational products or to any ingredients of the vehicles (i.e., excipients);

  9. Subject with skin abnormalities (e.g., scars, excessive hair, tattooing) or anydermatosis (e.g., psoriasis, eczema, acne vulgaris) on the face which couldinterfere with the study;

  10. Subject having applied any cosmetic product (care cream, lotion, body milk...) ordrug on the face (except usual cleansing products) within one week before the studyvisit (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 theClinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state);

  13. Subject who is in an exclusion period in the National Biomedical Research Registerof 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 ina medical or social establishment for any reason.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: HAFS Supplementation
Phase:
Study Start date:
January 02, 2025
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • CPCAD Hôpital L'Archet 2

    Nice, 06200
    France

    Active - Recruiting

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