Evaluation of the Effects of an Oral Supplementation Containing Hyaluronic Acid

NCT06774742 | Completed

• 1 other identifier: 2024-A01613-44
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Quality; Lips Quality; Persistence of the Effect

Keywords

skin hydration; skin quality; anti-aging; lips hydration; lips volume

Outcome Measures

Primary Outcomes (1)

• Skin hydration

  Facial skin hydration (Corneometer)

  Change from baseline to 3 months

Secondary Outcomes (7)

• Lip hydration

  From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

• Lip color

  From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

• Lip volume

  From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

• Skin barrier function

  From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

• Dermatological assessment of skin face

  From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end)

Study Arms (2)

HAFS Supplementation

EXPERIMENTAL

Hyaluronic acid full spectrum daily supplementation

Dietary Supplement: HAFS Supplementation

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

HAFS Supplementation DIETARY_SUPPLEMENT

1 capsule of HAFS per day

HAFS Supplementation

Placebo DIETARY_SUPPLEMENT

1 capsule of placebo per day

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject having signed an Informed Consent Form (ICF) before any trial related activity is carried out;
• Female subject;
• Subject aged 40 to 70 years inclusive at the time of signing the ICF;
• Subject with thin and dry lips;
• Subject with dry skin measured on the cheeks (corneometry \< 50);
• 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;
• Subject willing and able to follow all the study procedures and restrictions and complete the whole study phase;
• Subject affiliated to a health social security system (according to French Law).

You may not qualify if:

• Female subject who is pregnant or who is breast feeding;
• Female subject of childbearing potential with positive urine pregnancy test at the study visit (Day 1);
• Women with a BMI ≤ 17 or ≥ 32 kg/cm²;
• Subject with any uncontrolled diseases such as diabetes, hypertension, hyperthyroidism or hypothyroidism;
• 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;
• Subject with an history of sleeve or bypass
• Subject with current participation in any other interventional clinical study, based on interview of the subject;
• Subject with known or suspected hypersensitivity to any component(s) of the investigational products or to any ingredients of the vehicles (i.e., excipients);
• 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;
• 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);
• Subject impossible to contact in case of emergency;
• 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);
• 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.

Sponsors & Collaborators

• TS Biotech - Shandong Tiansheng Biotechnology Co., Ltd: lead

Study Sites (1)

CPCAD Hôpital L'Archet 2

Nice, 06200, France

Location

Related Publications (12)

• 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.

  PMID: 34933842 BACKGROUND

• 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.

  PMID: 34203487 BACKGROUND

• 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.

  PMID: 29228816 BACKGROUND

• 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.

  PMID: 31113187 BACKGROUND

• 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.

  PMID: 30636365 BACKGROUND

• 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.

  PMID: 16214414 BACKGROUND

• 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.

  PMID: 16822580 BACKGROUND

• 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.

  PMID: 30724463 BACKGROUND

• 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.

  PMID: 29374576 BACKGROUND

• 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.

  PMID: 32708202 BACKGROUND

• Stern R. Hyaluronan catabolism: a new metabolic pathway. Eur J Cell Biol. 2004 Aug;83(7):317-25. doi: 10.1078/0171-9335-00392.

  PMID: 15503855 BACKGROUND

• 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.

  PMID: 38009035 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blind. The products will be dispensed according to the randomization list by a responsible designated person other than the Investigator. The randomization list will be masked to the Investigator during the whole study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: January 2, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-01

Locations

FR (1)