evaluation of the effects of an oral supplementation containing hyaluronic acid

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

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 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.

Keywords: skin hydration skin quality anti-aging lips hydration lips volume