NativeSkin® human skin models

live first-in-human data generation

The NativeSkin® live human skin model

A cruelty-free highly predictive model for relevant study results

NativeSkin® human skin models provide the closest alternative to directly testing on a real person’s skin. NativeSkin® models are round human skin biopsies contained in a patented matrix that keeps them alive and functional. The model is designed to offer an innovative study platform for research and analysis to study the response of real, live human skin to compounds, drugs, cosmetics and medical devices after topical or systemic administration. A quick overview of the model’s features and benefits:

Immunocompetent

NativeSkin® models hold the features and functionalities of in vivo human skin, with all cells and appendages, to generate predictive human data.

Human

The models only contain real, donated human skin and are animal component free (ACF) / xeno-free (XF) for research and cosmetic testing.

Skin

NativeSkin® models are standardized to allow for reproducible research and testing on real, live human epidermis and dermis.

On Demand

NativeSkin access® skin models can be ordered online but our experts can also help you design the perfect NativeSkin® study to fit your needs.

Nativeskin immunocompetent human skin model

Live response from real human skin

A full week of testing opportunities

The NativeSkin® model is a live, patented ex vivo human skin model that contains round human skin biopsies from donated surgical discards. The skin is kept alive thanks to Genoskin’s patented technology, which allows keeping real human skin in a living state for 7 days. This approach helps us provide a highly relevant and reliable solution to pharmaceutical, biotech, cosmetic and chemical companies to test their compounds on real human skin for an entire week, without harming either humans or animals.

NativeSkin® keeps things real

Real human skin for real human data

As opposed to animal skin, bioprinted skin, human skin equivalents or reconstructed skin, NativeSkin® keeps things real. It truly is the real deal: NativeSkin® is human skin and it’s alive. It offers a valid, more reliable alternative to animal testing for predictive first-in-human data prior to clinical trials. Naturally, both the model and its culture medium are animal component free (ACF) / xeno-free (XF).

Ethical compliance & sourcing procedures

Official authorizations from French & US institutions

Approved by the Ethical Committees

Informed Consent from every donor

Secure agreements with contributing hospitals and clinics in France and in the US

More on ethical compliance

Real human epidermis & dermis with all cells, appendages and characteristics

Maintained skin barrier function, tissue integrity, morphology and physiology

Live human skin response to your compound, drug or cosmetic

Animal component free (ACF) / xeno-free (XF) model and culture medium

Safety tested for Hepatitis B, Hepatitis C, HIV 1 & 2

Donor information on age, gender, skin type, allergies, skin conditions and specific dermatological treatments

Informed consent

Informed consent from all donors, in compliance with all applicable regulations

Compliant procedures

Skin sourcing approved by all mandatory institutions in France and the US

Ethical & secure sourcing

Secure agreements with hospitals and clinics

Standardized production

Compliant & standardized production for reproducible results

Scientific validation in terms of skin structure

Human skin structure is maintained for +7 days

Since it is real human skin, NativeSkin® has the same structure and composition as in vivo human skin. It presents a mature stratum corneum and normal skin barrier function and their integrity can be preserved for 7 days. After 7 days of culture, experimental data may show higher variability but NativeSkin® remains viable. Hematoxilin & Eosin staining shows mature stratum corneum, a dermal-epidermal junction that comprises the key features of the dermal-epidermal junction of real human skin, with a preserved basal layer and rete ridges. The images also illustrate that dermis integrity is preserved for 7 days.

NativeSkin-HE staining - Epidermis D0-02
Day 0 - Epidermis & Papillary Dermis
NativeSkin HE staining epidermis Day 3
Day 3 - Epidermis & Papillary Dermis
Nativeskin - HE staining - Epidermis D7-04
Day 7 - Epidermis & Papillary Dermis
Nativeskin-HE-staining-Dermis-D0-05
Day 0 - Reticular Dermis
Nativeskin-HE-staining-Dermis-D3
Day 3 - Reticular Dermis
Nativeskin-HE-staining-Dermis-D7-07-1024x769
Day 7 - Reticular Dermis

Scientific validation of live human skin response

NativeSkin® models show real human skin response

Even though cell interaction may vary from one person to another and one skin type to the next, live cell interaction remains crucial when it comes to estimating the response of human skin to certain compounds. Thanks to Genoskin’s patented matrix, immune cells remain present and viable in NativeSkin®, allowing for real human skin response.

Exposure of NativeSkin® to pollution

To better characterize the consequences of exposure to pollution on human skin homeostasis, we incubated NativeSkin® models in a pollution chamber every day for four days. The pollution chamber was designed to mimic chronic low-level environmental exposure of five Volatile Organic Compounds (VOCs): hexane, toluene, acetaldehyde, formaldehyde and acetone. Results are shown below. You’ll find all the study details here.

Cell viability

Cell viability of NativeSkin after pollution

Pollution induces an important decrease in cell viability in NativeSkin®. This MTT assay shows a decrease of about 60% in cell viability.

Cell proliferation

Biologic validation of NativeSkin models for pollution measurement
Ki67 in untreated NativeSkin® model
Biologic validation of Nativeskin skin models for cell proliferation
Ki67 in polluted NativeSkin® model

Pollution exposure decreases cell proliferation. Cell proliferation was analyzed by immunostaining of NativeSkin® model for Ki-67. Proliferative cells were normally present in the non-polluted NativeSkin® models from day 0 to day 4. Exposure to pollution induced a 3.7 fold decrease of Ki-67 positive cells in the epidermis as compared to control.

Exposure of NativeSkin® to UV-rays

NativeSkin® is a relevant tool to assess protection against UVB damage. In order to demonstrate the response to UVB-rays, we irradiated NativeSkin® models with UVB dosed at 250 mJ/cm2 and 500 mJ/cm2 and compared the results with non-irradiated models.

Oxidative stress

Oxidative stress MDA in Nativeskin samples after UVB radiation

Malondialdehyde (MDA) measurement: as UVB radiation causes an increase in oxidative stress, we measured MDA formation in NativeSkin® samples. Results show an increase of MDA formation in the samples that were irradiated with UVB.

Cell apoptosis & thymine dimer formation

Active Caspase 3 0mJ - UV-02
Active Caspase 3 - 0mJ
Active Caspase 3 250mJ - UV-03
Active Caspase 3 - 250mJ
Active Caspase 3 - 250mJ
Active Caspase 3 - 250mJ
Thymine Dimer - 0mJ
Thymine Dimer - 0mJ
Thymine Dimer - 250mJ
Thymine Dimer - 250mJ
Thymine Dimer - 500mJ
Thymine Dimer - 500mJ

The results show that UVB induces important skin damage in NativeSkin® models. Immunostaining with anti-active Caspase 3 shows an important increase in cell apoptosis induced by UVB radiation. Immunostaining with anti-thymine dimer shows an important increase in the formation of thymine dimer, meaning that UVB radiation induces DNA damage in skin cells.

A versatile study platform for first-in-human data

Easy & relevant study results after topical and systemic administration

The NativeSkin® model is very versatile and suitable for a wide range of applications thanks to its unique configuration. The presence of human epidermis and dermis in the NativeSkin® model allows for systemic treatments and genomic readouts to study how skin cells and appendages respond to your compound after it has been added to the culture medium. The larger NativeSkin® models come with a silicone ring, which prevents compounds from leaking into the culture medium. This approach allows for true topical application in a sealed environment and relevant data for skin absorption and barrier function studies.

Systemic administration

Topical application

A wide range of applications

Pick the right method to assess your drug, cosmetic or medical device

The NativeSkin® model is suitable for a wide range of applications including preclinical efficacy and toxicity studies as well as cosmetic claim substantiation. The model is frequently used to evaluate all kinds of compounds, active ingredients and finished products, such as lotions, gels, creams… as well as medical devices, such as microneedle array patches (MAPs). Below, you’ll find some examples of the types of studies you can conduct with the NativeSkin® model.

Cosmetic claims

Studies on cosmetic & aesthetic claims

Skin delivery

Topical absorption & effects on skin metabolism

Toxicity

Compound toxicity & effects on barrier function

Wound healing

Wound healing properties & microbial colonisation

Skin microbiome

Effects on the skin microbiome & microbial colonization

Approved study protocols

How to analyze effects after applying your compound

  • Viability assay (MTT/WST-8)
  • Formalin fixation for paraffin embedding
  • OCT fixation and cryosectioning

  • Epidermal separation (with Dispase and heat-mediated)
  • H&E staining
  • Fontana Masson staining
  • Lucifer Yellow penetration

  • Human keratinocyte primary culture
  • RNA extraction
  • Immunofluorescence staining

Interested in learning more about these protocols?

Download them all for free and get your study started!

One model, two ways to get the results you need

Pick your preferred option & get your study going

NativeSkin® is available as an in-house service to conduct custom studies for a wide range of applications. Don’t hesitate to use our 10 years of experience so we can help you obtain relevant results to move your research forward. However, should you prefer to conduct the studies in your own labs, don’t hesitate to order directly via our online platform, as NativeSkin® is also the only human skin model available for shipment around the world.

Order NativeSkin® access

Try it in your own lab

Order our shippable NativeSkin® access models via our online platform and get them delivered straight to your lab ready-for-use, along with a step-by-step user manual.

order now

Design your NativeSkin® study

Let our experts help you out

Talk to our team of skin experts to design your custom study. Our lab will take care of everything and send you a comprehensive study report with relevant and actionable data.

contact us

Scientific publications using NativeSkin®

See how others use the NativeSkin® model to generate results

March 2024 - In vitro studies into establishing therapeutic bioequivalence of complex topical products: weight of evidence.

In vitro studies into establishing therapeutic bioequivalence of complex topical products: weight of evidence.
Published in Science Direct – March 25, 2024. 124012. https://doi.org/10.1016/j.ijpharm.2024.124012.
Margarida Miranda, Zoe Volmer, Alicia Cornick, Aidan Goody, Catarina Cardoso, Alberto A.C.C. Pais, Marc Brown, Carla Vitorino

December 2023 - Redefine photoprotection: Sun protection beyond sunburn.

Redefine photoprotection: Sun protection beyond sunburn.
Published in Experimental dermatology Wiley – December 15, 2023. Exp Dermatol. 2024;33:e15002. doi:10.1111/exd.15002.
Mirja van Bodegraven, Marius Kröger, Daniela F. Zamudio Díaz, Silke B. Lohan, Rose K. C. Moritz, Nadine Möller, Chiara Knoblich, Alexandra Vogelsang, Zorica Milinic, Matthias Hallhuber, Julia M. Weise, Ludger Kolbe, Julia Gallinger, Cindy Graupner, Holger Klose, Claas Ulrich, Martina C. Meinke

November 2023 - N-acetyl-L-hydroxyproline: A potent skin anti-ageing active preventing advanced glycation end-product formation in vitro and ex vivo

N-acetyl-L-hydroxyproline: A potent skin anti-ageing active preventing advanced glycation end-product formation in vitro and ex vivo
Published in International of Cosmetics Science – November 27, 2023.
Chiara Knoblich, Katja Dunckelmann, Andrea Krüger, Thomas Küper, Thomas Blatt, Julia M Weise

September 2023 - Household laundry detergents disrupt barrier integrity and induce inflammation in mouse and human skin.

Household laundry detergents disrupt barrier integrity and induce inflammation in mouse and human skin.
Published in European Journal of Allergy and Clinical Immunology, 2023 – September 27, 2023.
Arturo O. Rinaldi, Manru Li, Elena Barletta, Paolo D’Avino, Duygu Yazici, Yagiz Pat, Siobhan Ward, Daniel Burla, Ge Tan, Nima Askary, Rasmus Larsson, Jeremy Bost, Huseyn Babayev, Raja Dhir, Nicolas Gaudenzio, Mubeccel Akdis, Kari Nadeau, Cezmi A. Akdis, Yasutaka Mitamura

August 2023 - M1/M2 Macrophage Skewing is Related to Reduction in Type I, V and VI Collagens with Aging in Sun-exposed Human Skin

M1/M2 Macrophage Skewing is Related to Reduction in Type I, V and VI Collagens with Aging in Sun-exposed Human Skin
Published in JID Innovations, 2023, 100222, ISSN 2667-0267 – August 11, 2023.
Satoshi Horiba, Munetaka Kawamoto, Ryozo Tobita, Ryota Kami, Yuki Ogura, Junichi Hosoi

August 2023 - Hydrogel degradation promotes angiogenic and regenerative potential of cell spheroids for wound healing

Hydrogel degradation promotes angiogenic and regenerative potential of cell spheroids for wound healing.
Published in Materials Today Bio – Volume 22, 2023,100769, ISSN 2590-0064; Published: 29 September 2022.
Victoria L. Thai, David H. Ramos-Rodriguez, Meron Mesfin, J. Kent Leach.

August 2023 - Copper-based dressing: Efficacy in a wound infection of ex vivo human skin

Copper-based dressing: Efficacy in a wound infection of ex vivo human skin
Published in Tissue&Cell (Volume 84, October 2023, 102196) – August 22, 2023.
Aaron D. Strickland, Mehmet Ozturk, Tricia Conti, Fahimeh Tabatabaei

April 2023 - Mast cell tolerance in the skin microenvironment to commensal bacteria is controlled by fibroblasts

Mast cell tolerance in the skin microenvironment to commensal bacteria is controlled by fibroblasts
Published in National Library of Medicine – April 28, 2023.
Anna Di Nardo, Yu-Ling Chang, Shahrzad Alimohammadi, Kana Masuda-Kuroki, Zhenping Wang, Krishna Sriram, Paul A Insel

March 2023 - Dissolvable microneedles for transdermal drug delivery showing skin penetration and modified drug release

Dissolvable microneedles for transdermal drug delivery showing skin penetration and modified drug release
Published in European Journal of Pharmaceutical Sciences (Volume 182, 1 March 2023, 106371) – March 1, 2023.
Irina Iachina, André H Eriksson, Malene Bertelsen, Karsten Petersson, Jörgen Jansson, Pernille Kemp, Karen M Engell, Jonathan R Brewer, Kim T Nielsen

March 2023 - A Needle-free Transdermal Patch for Sampling Interstitial Fluid

A Needle-free Transdermal Patch for Sampling Interstitial Fluid
Published in IEEE Transactions on Biomedical Engineering ( Volume: 70, Issue: 9, September 2023) – March 8, 2023.
D. J. O’Brien, D. Mills, J. Farina and M. Paranjape

January 2022 - Characterization of a novel non-steroidal glucocorticoid receptor agonist optimized for topical treatment

January 2022 - Polymethoxyflavones from Kaempferia parviflora ameliorate skin aging in primary human dermal fibroblasts and ex vivo human skin

December 2021 - Barrier disruption, dehydration and inflammation: Investigation of the vicious circle underlying dry skin

December 2021 - A hypothetical skin sensitisation next generation risk assessment for coumarin in cosmetic products

October 2021 - The anti-wrinkles properties of sodium acetylated hyaluronate

October 2021 - A proof-of-concept study utilising 2D NMR spectrometry for in situ characterisation and quantitation of key biomarkers and actives in tape stripped ex vivo human skin

September 2021 - Clinical brightening efficacy and safety of Melasolv™ (3,4,5-trimethoxy cinnamate thymol ester, TCTE) in Southeast Asian women

February 2021 - hiPSC-Derived Epidermal Keratinocytes from Ichthyosis Patients Show Altered Expression of Cornification Markers

January 2021 - Challenges in Developing a Human Model System for Skin Microbiome Research

December 2020 - Active neutrophil responses counteract Candida albicans burn wound infection of ex vivo human skin explants

November 2020 - Synthesis of Kisspeptin-Mimicking Fragments and Investigation of their Skin Anti-Aging Effects

September 2020 - A novel skin brightening topical technology

  • A novel skin brightening topical technology
    • Published in Journal of Cosmetic Dermatology – 28 September 2020; 19: 3280– 3285
      • Zoe Diana Draelos MD, Isabel Diaz BA, Aaron Cohen PhD, Junhong Mao PhD, Thomas Boyd PhD

July 2020 - Highly accurate skin-specific methylome analysis algorithm as a platform to screen and validate therapeutics for healthy aging

April 2020 - Identification of Malassezia furfur Secreted Aspartyl Protease 1 (MfSAP1) and Its Role in Extracellular Matrix Degradation

April 2020 - Single-cell transcriptomes of the human skin reveal age-related loss of fibroblast priming

January 2020 - Mapping 2D- and 3D-distributions of metal/metal oxide nanoparticles within cleared human ex vivo skin tissues

January 2020 - Epidermal and Dermal Hallmarks of Photoaging are Prevented by Treatment with Night Serum Containing Melatonin, Bakuchiol, and Ascorbyl Tetraisopalmitate: In Vitro and Ex Vivo Studies

January 2020 - Anti-Wrinkle Benefits of Peptides Complex Stimulating Skin Basement Membrane Proteins Expression

2019 - An Efficient Means to Mitigate Skin Inflammaging by Inhibition of the NLRP3 Inflammasome and Nfkb Pathways: A Novel Epigenetic Mechanism

September 2019 - Peptidylarginine Deiminase Inhibitor Cl-Amidine Attenuates Cornification and Interferes with the Regulation of Autophagy in Reconstructed Human Epidermis

September 2019 - A human skin model to evaluate the protective effect of compounds against UVA damage

September 2019 - Poster - Scientific Visualisation of Skin Damage caused by Irritants in Human Skin

September 2019 - Poster - Ex vivo visualization and extended release from a dissolvable microarray

  • Ex vivo visualization and extended release from a dissolvable microarray
    • Scientific Poster presented at the 2019 Congress of the European Society for Dermatological Research (ESDR) – September 18-21, 2019
      • K. T. Nielsen, A. H. Eriksson, M. F. Carlsen, K. M. Engel, J. Jansson, K. Petersson, M. A. Røpke, M. Bertelsen, P. Kemp –
        LEO Pharma A/S, Ballerup, Denmark

September 2019 - Poster - Preservation of human skin integrity and metabolism during 10 days in culture with NativeSkin® system

July 2019 - The Actin-Based Motor Myosin Vb Is Crucial to Maintain Epidermal Barrier Integrity

June 2019 - The Amino-Terminal Part of Human FLG2 Is a Component of Cornified Envelopes

December 2018 - Melatonin, bakuchiol and ascorbyl tetraisopalmitate synergize to modulate gene expression and restore Hypoxia-Inducible Factor 1 signaling in UV-exposed skin

October 2018 - Phenotypic and lipidomic characterization of primary human epidermal keratinocytes exposed to simulated solar UV radiation

October 2018 - Myosin phosphatase accelerates cutaneous wound healing by regulating migration and differentiation of epidermal keratinocytes via Akt signaling pathway in human and murine skin

May 2018 - 3D imaging of cleared human skin biopsies using light-sheet microscopy: A new way to visualize in-depth skin structure

May 2018 - Poster - 3D imaging of cleared ex vivo normal human skin, skin appendages and psoriasiform skin lesion using light-sheet microscopy

May 2018 - Poster - NativeSkin®, an immunocompetent human skin model to study antigen uptake and processing by Langerhans cells

September 2017 - Oxidative damage and impairment of protein quality control systems in keratinocytes exposed to a volatile organic compounds cocktail

June 2017 - SIRT1 activation mediates heat-induced survival of UVB damaged Keratinocytes

January 2017 - Mechanistic insights into the impact of Cold Atmospheric Pressure Plasma on human epithelial cell lines

2016 - In vitro Dermal Absorption of Hydroquinone: Protocol Validation and Applicability on Illegal Skin-Whitening Cosmetics

November 2016 - Integrating targeted gene expression and a skin model system to identify functional inhibitors of the UV activated p38 MAP kinase

May 2016 - Heat-mediated reduction of apoptosis in UVB-damaged keratinocytes in vitro and in human skin ex vivo

October 2015 - In vitro and in vivo dermal absorption assessment of acetyl aspartic acid: a compartmental study

October 2015 - Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines

March 2015 - A Novel Explant Model for Skin Delivery Assessment

March 2015 - Human Skin Models for Research Applications in Pharmacology and Toxicology: Introducing NativeSkin®, the “Missing Link” Bridging Cell Culture and/or Reconstructed Skin Models and Human Clinical Testing

October 2014 - Calcipotriol counteracts betamethasone-induced decrease in extracellular matrix components related to skin atrophy

Contact us

Should you need more details on any of the above applications or publications, don’t hesitate to contact us.