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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAFS Supplementation | Experimental | Hyaluronic acid full spectrum daily supplementation |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAFS Supplementation | Dietary Supplement | 1 capsule of HAFS per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Skin hydration | Facial skin hydration (Corneometer) | Change from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lip hydration | Changes in lip hydration (Corneometer®) | From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Lip color | Changes in skin and lip color (Mexameter®) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD Hôpital L'Archet 2 | Nice | 06200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31113187 | 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. | |
| 30636365 | 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. |
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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.
| Placebo |
| Dietary Supplement |
1 capsule of placebo per day |
|
| From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Lip volume | Change from baseline in lip volume (LifeViz®) | From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Skin barrier function | The measurement of the TEWL gives an indication of the integrity of the barrier function of the stratum corneum. The TEWL will be measured on the face at each evaluation visit using a Vapometer SWL-2 (Delfin, technologies, Kuopio, Finland). This portable device contains moisture sensors in a closed chamber type probe. The conditions of a closed chamber are created by contact with the skin surface (surface of the chamber =1 cm²). The TEWL measurement is expressed in g/m²/h after a stabilization time of 10 to 20 seconds. | From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Dermatological assessment of skin face | Scoring system for the assessment of the skin face Skin dryness : 0= no dryness to 9= very dry skin Skin roughness : 0= no roughness to 9= severe roughness Skin evenness : 0= not even at all to 9= very even Skin suppleness : 0= not supple at all to 9= very supple skin Skin elasticity : 0= no elasticity at all to 9= maximal elasticity Skin firmness 0= no firm at all to 9= very firm Skin plumping 0= not plump at all to 9= very plump | From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Dermatological assessment of lips | At each evaluation visit, the lip qualities will be assessed by the Investigator/evaluator using the following 6-point scoring system from 0 to 5. Lips fullness 0= very thin to 5= very full Lips dryness 0= no dryness to 5= very dry lips Lips roughness 0= no roughness to 5= severe roughness | From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| Self assessment questionnaire |
| From baseline to Day 29, Day 84 and Day 98 (2 weeks after supplementation end) |
| 16214414 | 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. |
| 16822580 | 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. |
| 30724463 | 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. |
| 29374576 | 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. |
| 32708202 | 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. |
| 15503855 | 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. |
| 34933842 | Result | 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. |
| 34203487 | Result | 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. |
| 29228816 | Result | 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. |
| 38009035 | Result | 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. |