Development of a cumulative irritation model for incontinence-associated dermatitis
Incontinence-associated dermatitis (IAD) is a painful yet preventable form of cumulative skin irritation prevalent amongst those with limited movement. Consequently, it has a significant impact on the quality of life for those affected as well as substantial cost implications. Prevention and intervention is typically through good skin hygiene regimes and regular use of barrier products. In this paper, we describe the development of an in vivo model of IAD in healthy volunteers by occluded application of alkaline synthetic urine to the volar aspect of volunteer’s forearms for 6 h per day over a five-day period to reproduce the moist and irritant conditions causative of IAD. Irritation was assessed and quantified on a daily basis by a series of non-invasive biophysical measurements and compared to a contralateral saline-treated (control) site. Dermal irritation was assessed by subjective (visual) and objective measurements (laser Doppler and polarisation spectroscopic imaging, infrared thermography, skin reflectance spectroscopy, transepidermal water loss and skin surface pH). The provocation of reproducible, cumulative skin irritation was successfully demonstrated and quantified. This five-day model of irritation is considered appropriate for the initial clinical assessment of topical products to prevent or treat IAD.
KeywordsDermatitis Urine Biophysical instrument TEWL Skin reflectance spectroscopy Laser Doppler imaging Thermal imaging Tissue viability imaging
This study was funded by Bracco Diagnostics Inc. The authors would also like to thank Dr. John Skamarauskas for assistance with the analysis of TiVi images from the 5 day study, Professors Fabrizio Schifano and Ken Farrington for clinical support and Dr Richard Amlôt for statistical advice.
- 1.Agner T (1992) Noninvasive measuring methods for the investigation of irritant patch test reactions. A study of patients with hand eczema, atopic dermatitis and controls. Acta Derm Venereol Suppl 173:1–26Google Scholar
- 5.Beeckman D, Verhaeghe S, Defloor T, Schoonhoven L, Vanderwee K (2011) A 3-in-1 perineal care washcloth impregnated with dimethicone 3 % versus water and pH neutral soap to prevent and treat incontinence-associated dermatitis: a randomized, controlled clinical trial. J Wound Ostomy Cont Nurs 38(6):627–634. doi: 10.1097/WON.0b013e31822efe52 CrossRefGoogle Scholar
- 10.Celsus AC (0025) De medicina. Self publishedGoogle Scholar
- 13.Chilcott RP, Patel A, Ashley Z, Hughes JN, Parkes JA (2002) The effects of chemical damage on TEWL. In: Markes R, J-L L, Voefeli R (eds). London, pp 275–285Google Scholar
- 14.Clemmensen A, Andersen F, Petersen TK, Kalden H, Melgaard A, Andersen KE (2008) The irritant potential of n-propanol (nonanoic acid vehicle) in cumulative skin irritation: a validation study of two different human in vivo test models. Skin Res Technol 14(3):277–286. doi: 10.1111/j.1600-0846.2008.00291.x PubMedCrossRefGoogle Scholar
- 24.Levin J, Maibach HI (2014) Human skin buffering capacity—an updated overview. In: Barel AO, Paye M, Maibach HI (eds) Handbook of cosmetic science and technology, vol 4. CRC Press, Boca Raton, pp 157–162Google Scholar