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

September 28, 2017 updated by: University of Split, School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SLS irritation model and Treatment
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
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.
PLACEBO_COMPARATOR: SLS irritation model and No Treatment
SLS induced irritation on two sites each on forearms and back No treatment
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.
SHAM_COMPARATOR: Sham irritation and Treatment
Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
Other: Emollient, moisturizing cream
Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
NO_INTERVENTION: Sham irritation and No Treatment
Sham irritation (water) on two sites each on forearms and back No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Five measurements; baseline, irritation, first, third and ninth day of treatment
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).
Five measurements; baseline, irritation, first, third and ninth day of treatment
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).
Five measurements; baseline, irritation, first, third and ninth day of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five assessments: baseline, irritation, first, third and ninth day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 29, 2017

Primary Completion (ACTUAL)

September 28, 2017

Study Completion (ACTUAL)

September 28, 2017

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (ACTUAL)

July 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003-08/17-03/0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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