Models of reconstructed human skin provide useful tools for both basic research and evaluation of the safety and efficacy of dermato-cosmetological products. They can provide alternative models to replace human and animal experiments. However, their use requires confidence in their reproducibility and similarity of the results obtained as compared to in vivo experiments. Their morphology, architecture and properties must be as close as possible to human skin. The present paper reviews the results obtained on the EPISKIN™ model through characterisation of the model, reproducibility studies and multicentre studies or (pre)validations.
van de SandtJ.J.M., RoguetR., CohenC., EsdailleD., PonecM., CorsinilE., BackerK.L., FusenigN., LiebschM., BenfordD., de FraissinetteA., & FartashM. (1999). The use of human keratinocytes and human skin models for predicting skin irritation. The report and recommendations of ECVAM workshop 38. ATLA27, 743–760.
2.
FentemJ.H., BriggsD., ChesnéC., ElliotG., HarbellJ., HeylingsJ., RoguetR., van de SandtJ.J.M., & BothamPA. (2001). A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the management team. Toxicology in Vitro15, 57–93.
3.
RosdyM., & ClaussL.C. (1990). Complete human epidermal cell differentiation in chemically defined medium at the air-liquid interface on inert filter subtrates. Journal of Investigative Dermatology95, 409–414.
4.
TinoisE., TiollierJ., GaucherandM., DumasH., TardyM., & ThivoletJ. (1991). In vitro and post-transplantation differentiation of human keratinocytes growth on the human type IV collagen film of a bilayered dermal substitute. Experimental Cell Research193, 310–319.
5.
CannonC.L., NealP.J., SoutheeJ.A., KubiliusJ., & KlausnerM. (1994). New epidermal model for dermal irritancy testing. Toxicology in Vitro8, 889–891.
6.
TinoisE., GaetaniQ., GayraudB., DupondD., RougierA., & Pouradier DuteilX. (1994). Toxicology in vitro. The Episkin™ model: successful reconstruction of human epidermis in vitro, pp. 133–140. New York: Ann Liebert Inc. Publishers.
7.
BoelsmaE., GibbsS., FallerC., & PonecM. (2000). Characterization and comparison of reconstructed skin models: morphological and immunohistochemical evaluation. Acta Dermatologica Venerologica80, 82–88.
8.
PonecM., BoelsmaE., WeerheimA., MulderA., BouwstraJ., & MommasM. (2000). Lipid and ultra-structural characterization of reconstructed skin models. International Journal of Pharmacology203, 211–225.
9.
PrunierasM., RégnierM., & WoodleyD. (1983). Methods for cultivation of keratinocytes with an air–liquid interface. Journal of Investigative Dermatology81, 28s–33s.
10.
BellE., IvarssonB., & MerrillC. (1979). Production of a tissue-like structure by contraction of collagen lattices by human fibroblasts of different proliferative potential in vitro.Proceedings of the National Academy of Sciences USA76, 1274–1278.
11.
BernerdF., & MehulB. (2002). cDNA array based analysis of gene expression profile in three different models of reconstructed human epidermis. Journal of Investigative Dermatology119, 259.
12.
RoguetR., CohenC., LeclaireJ., TessonneaudE., GagneC., & TeissierM.H. (2000). Use of standardized reconstructed epidermis kit to assess in vitro the tolerance and efficacy of cosmetics. International Journal of Cosmetic Sciences22, 409–419.
13.
MossmanT. (1983). Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assay. Journal of Immunological Methods65, 55–62.
14.
RoguetR., RégnierM., CohenC., DossouK.G., & RougierA. (1994). The use of in vitro reconstructed human skin in dermatoxicity testing. Toxicology in Vitro8, 635–639.
15.
LotteC., PatouilletC., ZaniniM., MessagerA., & RoguetR. (2002). Permeation and skin absorption: reproducibility of various reconstructed human skin models. Skin Pharmacology and Applied Skin Physiology15, Suppl. 1, 18–30.
16.
HirelB., ChesneC., PailheretsJ.P., & GuillouzoA. (1995). In vitro expression of drug metabolising enzyme activities in human adult keratinocytes under various culture conditions and their responses to inducers. Toxicology in Vitro9, 49–56.
17.
CotovioJ., LeclaireJ., & RoguetR. (1997). Cytochrome P450-dependent enzyme activities in normal adult human keratinocytes and transformed human keratinocytes. In Vitro Toxicology10, 207–216.
18.
RoguetR., CotovioJ., KremersP., RougierA., Pouradier DuteilX., & LeclaireJ. (1995). Cytochrome P450-dependent enzyme activities and testosterone metabolism in a reconstructed human epidermis. In Vitro Toxicology8, 97–104.
19.
HarrisI.R., SiefkenW., Beck-OldachK., BrandtM., WitternK.P., & PolletD. (2002). Comparison of activities dependent on glutathione S-transferase and cytochrome P-450 IA1 in cultured keratinocytes and reconstructed epidermal models. Skin Pharmacology and Applied Skin Physiology15, Suppl. 1, 59–67.
20.
HarrisI.R., SiefkenW., Beck-OldachK., WitternK.P., & PolletD. (2002). NAD(P)H:Quinone reductase activity in human epidermal keratinocytes and reconstructed epidermal models. Skin Pharmacology and Applied Skin Physiology15, Suppl. 1, 68–73.
21.
CotovioJ., RoguetR., PionF.X., RougierA., & LeclaireJ. (1996). Effect of imidazole derivatives on cytochrome P-450 enzyme activities in a reconstructed human epidermis. Skin Pharmacology and Applied Skin Physiology9, 242–249.
22.
RoguetR., CohenC., LeclaireJ., & RougierA. (1996). The use of a reconstructed epidermis in the assessment of cytotoxic effects of UV radiations. Nouveau Dermatology15, 384–389.
23.
PortesP., PygmalionJ., PopovicE., CottinM., & MarianiM. (2002). Use of human reconstituted epidermis EPISKIN™ for the assessment of weak phototoxic potential of chemical compounds. Photodermatology, Photoimmunology and Photomedicine18, 96–102.
24.
RoguetR., CohenC., RoblesC., CourtellementP., TolleM., GuillotJ.P., & Pouradier DuteilX. (1998). An interlaboratory study of the reproducibility and relevance of EPISKIN™, a reconstructed human epidermis, in the assessment of cosmetic irritancy. Toxicology in Vitro12, 295–304.
25.
FallerC., BracherM., DamiN., & RoguetR. (2002). Predictive ability of reconstructed human epidermis equivalents for the assessment of skin irritation of cosmetics. Toxicology in Vitro16, 557–572.
26.
PortesP., GrandidierM.H., CohenC., & RoguetR. (2002). Refinement of the EPISKIN protocol for the assessment of acute skin irritation of chemicals: follow up to the ECVAM prevalidation study. Toxicology in Vitro16, 765–770.
FentemJ.H., ArcherG.E.B., BallsM., BothamP.A., CurrenR.D., EarlL.K., EsdailleD.J., HolzhütterH-G., & LiebschM. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro12, 483–524.
29.
OECD (1992). OECD Guidelines for the Testing of Chemicals, No 404: Acute Dermal Irritation/Corrosion.Paris, France: OECD.
30.
CotovioJ., OnnoL., JustineP., LamureS., & CatrouxP. (2001). Generation of oxidative stress in human cutaneous models following in vitro ozone exposureToxicology in Vitro15, 357–362.
31.
DuvalC., RegnierM., & SchmidtR. (2001). Distinct melanogenetic response of human melanocytes in mono-culture, co-culture with keratinocytes and reconstructed epidermis, to UV exposure. Pigment Cell Research14, 348–355.
32.
ToddC., HewittS.D., KempenaarJ., NozK., ThodyA.J., & PonecM. (1993). Co-culture of human melanocytes and keratinocytes in a skin equivalent model: effect of ultraviolet radiation. Archives of Dermatology Research285, 455–459.
33.
RegnierM., StaquetM.J., SchmittD., & SchmidtR. (1997). Integration of Langerhans cells into a pigmented reconstructed human epidermis. Journal of Investigative Dermatology109, 510–512.
34.
BernerdF., ViouxC., & AsselineauD. (2000). Evaluation of the protective effect of sunsceens on in vitro reconstructed human skin exposed to UVB or UVA irradiation. Photochemistry and Photobiology7, 314–320.
