Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd

Status

Completed

Conditions

Skin Quality

Lips Quality

Persistence of the Effect

Treatments

Dietary Supplement: Placebo

Dietary Supplement: HAFS Supplementation

Study type

Interventional

Funder types

Industry

Identifiers

NCT06774742

2024-A01613-44

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
Female subject;
Subject aged 40 to 70 years inclusive at the time of signing the ICF;
Subject with thin and dry lips;
Subject with dry skin measured on the cheeks (corneometry < 50);
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;
Subject willing and able to follow all the study procedures and restrictions and complete the whole study phase;
Subject affiliated to a health social security system (according to French Law).

Exclusion criteria

Female subject who is pregnant or who is breast feeding;
Female subject of childbearing potential with positive urine pregnancy test at the study visit (Day 1);
Women with a BMI ≤ 17 or ≥ 32 kg/cm²;
Subject with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
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;
Subject with an history of sleeve or bypass
Subject with current participation in any other interventional clinical study, based on interview of the subject;
Subject with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
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;
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);
Subject impossible to contact in case of emergency;
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);
Subject who is in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization;
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.