Effects of an oral supplement with hyaluronic acid on skin and lips quality

Evaluation of the Effects of a Dietary Supplement Containing a Full Range of Hyaluronic Acids in Healthy Female Subjects with Dry Facial Skin and Lips

This study tests whether taking an oral supplement with hyaluronic acid can improve skin and lip quality in women aged 40 to 70.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 40 Years to 70 Years
• Sex: Female
• Sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Nice)
• Trial ID: NCT06774742 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of an oral supplementation containing hyaluronic acid on skin hydration and quality in adult females aged 40 to 70. It is a double-blind, randomized, placebo-controlled study involving 130 participants, with 120 expected to complete the study over a period of 14 weeks. Participants will be assigned to either the hyaluronic acid group or a placebo group and will attend five visits throughout the study to monitor their progress and outcomes.

Who should consider this trial

Good fit: Ideal candidates are adult females aged 40 to 70 with thin, dry lips and dry skin.

Not a fit: Patients who are pregnant, breastfeeding, or have uncontrolled diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve skin hydration and quality for women experiencing dryness and aging effects.

How similar studies have performed: Other studies have shown positive outcomes with oral supplementation for skin hydration, suggesting potential success for this approach.

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.

Where this trial is running

Nice

• CPCAD Hôpital L'Archet 2 — Nice, France (Recruiting)

Study contacts

• Study coordinator: Catherine Queille Roussel

Conditions Skin Quality; Lips Quality; Persistence of the Effect; skin hydration; skin quality; anti-aging; lips hydration; lips volume