Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid
NCT ID: NCT06774742
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2025-01-02
2025-07-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HAFS Supplementation
Hyaluronic acid full spectrum daily supplementation
HAFS Supplementation
1 capsule of HAFS per day
Placebo
Placebo
1 capsule of placebo per day
Interventions
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HAFS Supplementation
1 capsule of HAFS per day
Placebo
1 capsule of placebo per day
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
70 Years
FEMALE
Yes
Sponsors
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TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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CPCAD Hôpital L'Archet 2
Nice, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Stern R. Hyaluronan catabolism: a new metabolic pathway. Eur J Cell Biol. 2004 Aug;83(7):317-25. doi: 10.1078/0171-9335-00392.
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.
Other Identifiers
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2024-A01613-44
Identifier Type: -
Identifier Source: org_study_id
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