Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery

Overview

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.

Full Title of Study: “Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 28, 2017

Interventions

  • Procedure: Sodium lauryl sulphate induced irritation
    • 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.
  • Other: Emollient, moisturizing cream
    • Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.

Arms, Groups and Cohorts

  • Experimental: SLS irritation model and Treatment
    • SLS induced irritation on two sites each on forearms and back Emollient cream treatment
  • Placebo Comparator: SLS irritation model and No Treatment
    • SLS induced irritation on two sites each on forearms and back No treatment
  • Sham Comparator: Sham irritation and Treatment
    • Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
  • No Intervention: Sham irritation and No Treatment
    • Sham irritation (water) on two sites each on forearms and back No treatment

Clinical Trial Outcome Measures

Primary Measures

  • Transepidermal water loss
    • Time Frame: Five measurements; baseline, irritation, first, third and ninth day of treatment
    • Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
  • Stratum corneum hydration
    • Time Frame: Five measurements; baseline, irritation, first, third and ninth day of treatment
    • Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
  • Erythema
    • Time Frame: Five measurements; baseline, irritation, first, third and ninth day of treatment
    • Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).

Secondary Measures

  • Clinical score
    • Time Frame: Five assessments: baseline, irritation, first, third and ninth day of treatment
    • 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Split, School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dario Leskur, MPharm, Principal Investigator, University of Split, School of Medicine

References

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