Irritant Contact Dermatitis Clinical Trial
Official title:
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
Verified date | June 2017 |
Source | University of Split, School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 28, 2017 |
Est. primary completion date | September 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - young, healthy volunteers who gave written informed consent Exclusion Criteria: - skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior the inclusion and during the trial, use of emollients three days prior the inclusion in the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation |
Country | Name | City | State |
---|---|---|---|
Croatia | School of Medicine | Split |
Lead Sponsor | Collaborator |
---|---|
University of Split, School of Medicine |
Croatia,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transepidermal water loss | Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2). | Five measurements; baseline, irritation, first, third and ninth day of treatment | |
Primary | Stratum corneum hydration | Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU). | Five measurements; baseline, irritation, first, third and ninth day of treatment | |
Primary | Erythema | Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU). | Five measurements; baseline, irritation, first, third and ninth day of treatment | |
Secondary | Clinical score | Skin response to irritation and treatment will be assessed using a five-point scale to describe changes in skin erythema, roughness, scaling, oedema, and fissures. | Five assessments: baseline, irritation, first, third and ninth day of treatment |
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