Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
Lead Sponsor: University of Split, School of Medicine
|Source||University of Split, School of Medicine|
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.
|Start Date||August 29, 2017|
|Completion Date||September 28, 2017|
|Primary Completion Date||September 28, 2017|
Intervention Type: Procedure
Intervention Name: Sodium lauryl sulphate induced irritation
Description: Sodium lauryl sulphate will be applied to specified skin sites according to randomization protocol to induce irritation. 60 uL of 2% w/v SLS will be applied to skin under occlusion by large Finn chamber for 24 hours as described in the guidelines by Standardization group of European Society of Contact Dermatitis.
Intervention Type: Other
Intervention Name: Emollient, moisturizing cream
Description: Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
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
- young, healthy volunteers who gave written informed consent
- 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
Minimum Age: 18 Years
Maximum Age: 35 Years
Healthy Volunteers: Accepts Healthy Volunteers
|Has Expanded Access||No|
|Number Of Arms||4|
Label: SLS irritation model and Treatment
Description: SLS induced irritation on two sites each on forearms and back Emollient cream treatment
Label: SLS irritation model and No Treatment
Type: Placebo Comparator
Description: SLS induced irritation on two sites each on forearms and back No treatment
Label: Sham irritation and Treatment
Type: Sham Comparator
Description: Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
Label: Sham irritation and No Treatment
Type: No Intervention
Description: Sham irritation (water) on two sites each on forearms and back No treatment
|Study Design Info||
Intervention Model: Single Group Assignment
Primary Purpose: Other
Masking: None (Open Label)