Irritant Contact Dermatitis Clinical Trial
Official title:
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model
for testing efficacy of various topical preparations. Aforementioned model is standardized
and described in guidelines, but it is not explicitly stated where the irritation should be
induced. Published clinical trials usually irritate volar aspect of forearms or upper back.
Also, lower back and dorsal aspect of forearm are sometimes used.
Skin parameters vary depending on anatomic location of measured skin. There is a difference
in stratum corneum thickness, hydration and transepidermal water loss across different
locations, including between volar forearm and upper back.
Furthermore, regional difference in skin response to irritation by tape stripping and
benzalkonium chloride were observed. Such differences are also possible in SLS irritation
model. One study has shown higher, but not statistically significant, response of back in
comparison to forearms, but it had a very small sample size (n=9).
Moreover, there are regional variations of topical preparations absorption. Hydrocortisone
had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those
variations could be explained by different corneocyte size and number of their layers between
back and hands.
Skin baseline properties and response to irritation seem to be dependent on anatomic
position. Those differences could mean different response to treatment. Since published
trials only tested efficacy of various preparations on one anatomic location, it is possible
their results would be different if tested on other body parts. It could limit validity and
usefulness of conducted trials. The aim of this study is to determine if there are regional
differences of skin response to irritation and emollient cream treatment in irritant contact
dermatitis model.
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