Clinical trial NCT06774742: Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Quality
Lips Quality
Persistence of the Effect
Keywords: skin hydration
skin quality
anti-aging
lips hydration
lips volume
Lead sponsor: TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Skin hydration
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Lip hydration
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Lip color
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Lip volume
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Skin barrier function
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Dermatological assessment of skin face
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Dermatological assessment of lips
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
measure: Self assessment questionnaire
timeFrame: From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD Hôpital L'Archet 2
Study officials:
References:
citation: Michelotti A, Cestone E, De Ponti I, Pisati M, Sparta E, Tursi F. Oral intake of a new full-spectrum hyaluronan improves skin profilometry and ageing: a randomized, double-blind, placebo-controlled clinical trial. Eur J Dermatol. 2021 Dec 1;31(6):798-805. doi: 10.1684/ejd.2021.4176.
citation: Hsu TF, Su ZR, Hsieh YH, Wang MF, Oe M, Matsuoka R, Masuda Y. Oral Hyaluronan Relieves Wrinkles and Improves Dry Skin: A 12-Week Double-Blinded, Placebo-Controlled Study. Nutrients. 2021 Jun 28;13(7):2220. doi: 10.3390/nu13072220.
citation: Gollner I, Voss W, von Hehn U, Kammerer S. Ingestion of an Oral Hyaluronan Solution Improves Skin Hydration, Wrinkle Reduction, Elasticity, and Skin Roughness: Results of a Clinical Study. J Evid Based Complementary Altern Med. 2017 Oct;22(4):816-823. doi: 10.1177/2156587217743640. Epub 2017 Dec 4.
citation: Linkov G, Wick E, Kallogjeri D, Chen CL, Branham GH. Perception of upper lip augmentation utilizing simulated photography. Arch Plast Surg. 2019 May;46(3):248-254. doi: 10.5999/aps.2018.01319. Epub 2019 May 15.
citation: Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12.
citation: Day AJ, de la Motte CA. Hyaluronan cross-linking: a protective mechanism in inflammation? Trends Immunol. 2005 Dec;26(12):637-43. doi: 10.1016/j.it.2005.09.009. Epub 2005 Oct 7.
citation: Stern R, Asari AA, Sugahara KN. Hyaluronan fragments: an information-rich system. Eur J Cell Biol. 2006 Aug;85(8):699-715. doi: 10.1016/j.ejcb.2006.05.009. Epub 2006 Jul 5.
citation: Tavianatou AG, Caon I, Franchi M, Piperigkou Z, Galesso D, Karamanos NK. Hyaluronan: molecular size-dependent signaling and biological functions in inflammation and cancer. FEBS J. 2019 Aug;286(15):2883-2908. doi: 10.1111/febs.14777. Epub 2019 Feb 21.
citation: Heldin P, Lin CY, Kolliopoulos C, Chen YH, Skandalis SS. Regulation of hyaluronan biosynthesis and clinical impact of excessive hyaluronan production. Matrix Biol. 2019 May;78-79:100-117. doi: 10.1016/j.matbio.2018.01.017. Epub 2018 Jan 31.
citation: Abatangelo G, Vindigni V, Avruscio G, Pandis L, Brun P. Hyaluronic Acid: Redefining Its Role. Cells. 2020 Jul 21;9(7):1743. doi: 10.3390/cells9071743.
citation: Stern R. Hyaluronan catabolism: a new metabolic pathway. Eur J Cell Biol. 2004 Aug;83(7):317-25. doi: 10.1078/0171-9335-00392.
citation: Gao YR, Wang RP, Zhang L, Fan Y, Luan J, Liu Z, Yuan C. Oral administration of hyaluronic acid to improve skin conditions via a randomized double-blind clinical test. Skin Res Technol. 2023 Nov;29(11):e13531. doi: 10.1111/srt.13531.