Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Skin Quality

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Skin hydration

Facial skin hydration (Corneometer)

Time frame: Change from baseline to 3 months