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Synthetic nanoclay gels do not cause skin irritation in healthy human volunteers

Synthetic nanoclay gels do not cause skin irritation in healthy human volunteers
Synthetic nanoclay gels do not cause skin irritation in healthy human volunteers
Synthetic clays are promising biomaterials for delivery of therapeutic molecules in regenerative medicine. However, before their use can be translated into clinical applications, their safety must be assessed in human volunteers. The aim of this study was to test the hypothesis that a synthetic nanoclay (LAPONITE) does not cause irritation to the human skin. To achieve this, a nanoclay gel at two different concentrations (1.5 and 3% w/v) was applied on the forearm of healthy volunteers for 24 h. 1% sodium lauryl sulfate (SLS) and 3% (w/v) polyacrylic acid were used as the positive and negative controls, respectively. The compromise in the skin barrier function was measured by trans-epidermal water loss (TEWL), erythema by spectroscopic measurements, and skin inflammatory biomarkers (IL-1α and IL-1RA) by the enzyme-linked immunosorbent assay. We found that the nanoclay caused no prolonged increase in TEWL, erythema, or induction of inflammatory cytokines. This was in contrast to 1% SLS, a known irritant, which induced significant increases in both skin erythema and TEWL. We conclude that the nanoclay is not an irritant and is thus suitable for therapeutic interventions at the skin surface.
hydrogel, irritant, laponite, nanoclay, skin barrier function, skin patch assay
2373-9878
2716-2722
Bostan, Luciana E
9b269056-e210-4ab7-815a-f373528dcd66
Clarkin, Claire E
05cd2a88-1127-41aa-a29b-7ac323b4f3c9
Mousa, Mohamed
f415be35-3a79-48c2-b6f5-e03fc564c5e2
Worsley, Peter R
44bc022c-0bea-4df9-bfb7-f3469992bfa1
Bader, Daniel L
9884d4f6-2607-4d48-bf0c-62bdcc0d1dbf
Dawson, Jonathan I
b220fe76-498d-47be-9995-92da6c289cf3
Evans, Nicholas D
06a05c97-bfed-4abb-9244-34ec9f4b4b95
Bostan, Luciana E
9b269056-e210-4ab7-815a-f373528dcd66
Clarkin, Claire E
05cd2a88-1127-41aa-a29b-7ac323b4f3c9
Mousa, Mohamed
f415be35-3a79-48c2-b6f5-e03fc564c5e2
Worsley, Peter R
44bc022c-0bea-4df9-bfb7-f3469992bfa1
Bader, Daniel L
9884d4f6-2607-4d48-bf0c-62bdcc0d1dbf
Dawson, Jonathan I
b220fe76-498d-47be-9995-92da6c289cf3
Evans, Nicholas D
06a05c97-bfed-4abb-9244-34ec9f4b4b95

Bostan, Luciana E, Clarkin, Claire E, Mousa, Mohamed, Worsley, Peter R, Bader, Daniel L, Dawson, Jonathan I and Evans, Nicholas D (2021) Synthetic nanoclay gels do not cause skin irritation in healthy human volunteers. ACS Biomaterials Science & Engineering, 7 (6), 2716-2722. (doi:10.1021/acsbiomaterials.0c01615).

Record type: Article

Abstract

Synthetic clays are promising biomaterials for delivery of therapeutic molecules in regenerative medicine. However, before their use can be translated into clinical applications, their safety must be assessed in human volunteers. The aim of this study was to test the hypothesis that a synthetic nanoclay (LAPONITE) does not cause irritation to the human skin. To achieve this, a nanoclay gel at two different concentrations (1.5 and 3% w/v) was applied on the forearm of healthy volunteers for 24 h. 1% sodium lauryl sulfate (SLS) and 3% (w/v) polyacrylic acid were used as the positive and negative controls, respectively. The compromise in the skin barrier function was measured by trans-epidermal water loss (TEWL), erythema by spectroscopic measurements, and skin inflammatory biomarkers (IL-1α and IL-1RA) by the enzyme-linked immunosorbent assay. We found that the nanoclay caused no prolonged increase in TEWL, erythema, or induction of inflammatory cytokines. This was in contrast to 1% SLS, a known irritant, which induced significant increases in both skin erythema and TEWL. We conclude that the nanoclay is not an irritant and is thus suitable for therapeutic interventions at the skin surface.

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Author Accepted Manuscript - Synthetic nanoclay gels do not cause skin irritation in healthy human volunteers - Accepted Manuscript
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e-pub ahead of print date: 7 April 2021
Published date: 7 April 2021
Additional Information: Funding Information: The authors acknowledge funding support from Medical Research Council UK Confidence in Concept (grant number MC_PC_17177) and EPSRC (grant number EP/S017054/1). Publisher Copyright: © 2021 American Chemical Society. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: hydrogel, irritant, laponite, nanoclay, skin barrier function, skin patch assay

Identifiers

Local EPrints ID: 449686
URI: http://eprints.soton.ac.uk/id/eprint/449686
ISSN: 2373-9878
PURE UUID: 3857f2ba-e372-40c7-9649-41e6d8db6279
ORCID for Luciana E Bostan: ORCID iD orcid.org/0000-0003-3882-2619
ORCID for Daniel L Bader: ORCID iD orcid.org/0000-0002-1208-3507
ORCID for Jonathan I Dawson: ORCID iD orcid.org/0000-0002-6712-0598
ORCID for Nicholas D Evans: ORCID iD orcid.org/0000-0002-3255-4388

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Date deposited: 10 Jun 2021 16:33
Last modified: 17 Mar 2024 06:32

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Contributors

Author: Luciana E Bostan ORCID iD
Author: Mohamed Mousa
Author: Peter R Worsley
Author: Daniel L Bader ORCID iD

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