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

Sponsors

Lead Sponsor: University of Split, School of Medicine

Source University of Split, School of Medicine
Brief Summary

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.

Overall Status Completed
Start Date August 29, 2017
Completion Date September 28, 2017
Primary Completion Date September 28, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Transepidermal water loss Five measurements; baseline, irritation, first, third and ninth day of treatment
Stratum corneum hydration Five measurements; baseline, irritation, first, third and ninth day of treatment
Erythema Five measurements; baseline, irritation, first, third and ninth day of treatment
Secondary Outcome
Measure Time Frame
Clinical score Five assessments: baseline, irritation, first, third and ninth day of treatment
Enrollment 25
Condition
Intervention

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.

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Dario Leskur, MPharm Principal Investigator University of Split, School of Medicine
Location
Facility: School of Medicine
Location Countries

Croatia

Verification Date

June 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: SLS irritation model and Treatment

Type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov