Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

Not Applicable

Recruiting

• Conditions: Skin Quality; Persistence of the Effect; Lips Quality

• Registration Number: NCT06774742
• Lead Sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-02
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin hydration	Change from baseline to 3 months	Facial skin hydration (Corneometer)

Secondary Outcome Measures

Name	Time	Method
Lip volume	From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)	Change from baseline in lip volume (LifeViz®)
Skin barrier function	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.
Dermatological assessment of lips	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
Self assessment questionnaire	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
Lip color	From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)	Changes in skin and lip color (Mexameter®)
Lip hydration	From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)	Changes in lip hydration (Corneometer®)
Dermatological assessment of skin face	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

Trial Locations

Locations (1)

CPCAD Hôpital L'Archet 2; 🇫🇷 Nice, France