Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

Launched by TS BIOTECH - SHANDONG TIANSHENG BIOTECHNOLOGY CO., LTD · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is examining the effects of an oral supplement containing hyaluronic acid, aimed at improving skin and lip quality, particularly hydration. The study is looking for 130 women between the ages of 40 and 70 who have thin, dry lips and dry skin. Eligible participants must be willing to follow study guidelines and attend five visits over the course of about 14 weeks. The women will be randomly divided into two groups: one will receive the hyaluronic acid supplement, while the other will receive a placebo (a non-active pill) without knowing which one they are taking.

Participants can expect to visit the clinic for screenings, baseline assessments, and follow-ups to measure changes in their skin and lip hydration, and overall quality. The study will also check how long any benefits last after stopping the supplement. It's important to note that women who are pregnant, breastfeeding, or have certain health conditions won't be eligible for this study. This trial aims to provide valuable information about the effectiveness and safety of the supplement for improving skin and lips.

Gender

FEMALE

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.