Multicenter evaluation of a topical hyaluronic acid serum.


Journal

Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964

Informations de publication

Date de publication:
Sep 2022
Historique:
revised: 06 07 2022
received: 03 05 2022
accepted: 11 07 2022
pubmed: 15 7 2022
medline: 28 9 2022
entrez: 14 7 2022
Statut: ppublish

Résumé

A new hyaluronic acid (HA) formulation was developed based on high molecular weight (MW) compounds used on the surface of the skin while using peptides to stimulate the high MW HA production by fibroblasts and keratinocytes from within the skin layers. Detailed science has been submitted to this journal in a previous publication. This multicenter study aims to validate the science by demonstrating the safety and efficacy of the product in the clinical realm. This study evaluated the efficacy and safety of a topical HA serum in facial skin. An open-label clinical study was undertaken over 4 months from November 2021 to March 2022. Participants applied the topical serum twice daily and were provided a gentle cleanser and an SPF 30+ to use in the morning. Follow-up visits were conducted at weeks 2, 4, and 8. At every visit, participants were measured for hydration post 15 minutes of cleansing the skin and post 15 minutes of product application for cumulative skin hydration sensor measurements. Additional procedures included participant assessments and satisfaction, investigator assessments, biopsies, and photography. At each follow-up visit, there was an increase in hydration measurements compared to baseline, in both immediate scores and cumulative long-term scores. At weeks 4 and 8, there was a statistically significant increase in hydration compared to baseline and the prior visit. Participants' assessments progressively increased over 2-, 4-, and 8-week intervals with significantly favorable ratings in all measured parameters. Similarly, investigator assessment grades were statistically significant (p < 0.0001) for decreased fine lines/wrinkling, crepiness, texture, erythema, and dryness, and increased (p < 0.0001) for moisture/hydration. Histology revealed increased CD44 staining in 6 of the 7 participants biopsied, denoting increased HA stimulation. In all of the participant biopsies, H&E staining demonstrated improvement in solar elastosis. Photography revealed remarkable improvement in erythema, tone, and texture. The study results demonstrated that the formulation produced significant improvements in immediate and long-term hydration effects on the skin as measured by the skin hydration sensor, 'wearifi' technology, comparison of before and after biopsies, and participant and investigator assessments. This high MW HA formulation produced excellent clinical improvement in skin health and hydration.

Sections du résumé

BACKGROUND BACKGROUND
A new hyaluronic acid (HA) formulation was developed based on high molecular weight (MW) compounds used on the surface of the skin while using peptides to stimulate the high MW HA production by fibroblasts and keratinocytes from within the skin layers. Detailed science has been submitted to this journal in a previous publication. This multicenter study aims to validate the science by demonstrating the safety and efficacy of the product in the clinical realm.
OBJECTIVES OBJECTIVE
This study evaluated the efficacy and safety of a topical HA serum in facial skin.
METHODS METHODS
An open-label clinical study was undertaken over 4 months from November 2021 to March 2022. Participants applied the topical serum twice daily and were provided a gentle cleanser and an SPF 30+ to use in the morning. Follow-up visits were conducted at weeks 2, 4, and 8. At every visit, participants were measured for hydration post 15 minutes of cleansing the skin and post 15 minutes of product application for cumulative skin hydration sensor measurements. Additional procedures included participant assessments and satisfaction, investigator assessments, biopsies, and photography.
RESULTS RESULTS
At each follow-up visit, there was an increase in hydration measurements compared to baseline, in both immediate scores and cumulative long-term scores. At weeks 4 and 8, there was a statistically significant increase in hydration compared to baseline and the prior visit. Participants' assessments progressively increased over 2-, 4-, and 8-week intervals with significantly favorable ratings in all measured parameters. Similarly, investigator assessment grades were statistically significant (p < 0.0001) for decreased fine lines/wrinkling, crepiness, texture, erythema, and dryness, and increased (p < 0.0001) for moisture/hydration. Histology revealed increased CD44 staining in 6 of the 7 participants biopsied, denoting increased HA stimulation. In all of the participant biopsies, H&E staining demonstrated improvement in solar elastosis. Photography revealed remarkable improvement in erythema, tone, and texture.
CONCLUSIONS CONCLUSIONS
The study results demonstrated that the formulation produced significant improvements in immediate and long-term hydration effects on the skin as measured by the skin hydration sensor, 'wearifi' technology, comparison of before and after biopsies, and participant and investigator assessments. This high MW HA formulation produced excellent clinical improvement in skin health and hydration.

Identifiants

pubmed: 35833366
doi: 10.1111/jocd.15241
pmc: PMC9804499
doi:

Substances chimiques

Peptides 0
Hyaluronic Acid 9004-61-9

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

3848-3858

Subventions

Organisme : Alastin Skincare, Inc.

Informations de copyright

© 2022 Alastin Skincare, Inc and The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

Références

Dermatoendocrinol. 2012 Jul 1;4(3):253-8
pubmed: 23467280
Cell Death Dis. 2016 Nov 10;7(11):e2461
pubmed: 27831556
J Cosmet Dermatol. 2022 Sep;21(9):3848-3858
pubmed: 35833366
ACS Biomater Sci Eng. 2015 Jul 13;1(7):481-493
pubmed: 26280020
Wounds. 2016 Mar;28(3):78-88
pubmed: 26978861
J Cosmet Dermatol. 2022 Jul;21(7):2865-2870
pubmed: 35486441

Auteurs

Deanne Mraz Robinson (DM)

Modern Dermatology, PLLC, New Haven, Connecticut, USA.
Dermatology, Yale, New Haven, Connecticut, USA.
Ideal Image, Tampa, Florida, USA.

Janelle Vega (J)

Mayoral Dermatology, Miami, Florida, USA.

Melanie D Palm (MD)

Art of Skin MD, Solana Beach, California, USA.
University of California, San Diego, California, USA.

Michaela Bell (M)

Alastin Skincare, Inc., a Galderma company, Carlsbad, California, USA.

Alan D Widgerow (AD)

Alastin Skincare, Inc., a Galderma company, Carlsbad, California, USA.
Division Chief, Research, Center for Tissue Engineering, Professor of Plastic Surgery, University of California, Irvine, California, USA.

Alessia Giannini (A)

DMR Research, PLLC, New Haven, Connecticut, USA.

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Classifications MeSH