Skip to main content
OpenTrials
Completed

NCT Number: NCT03231813

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritant Contact Dermatitis Dermatitis Dermatitis, Contact Dermatitis, Irritant Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine

Split, 21000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium lauryl sulphate induced irritation

Procedure

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.

Emollient, moisturizing cream

Other

Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.

Primary outcomes

  1. 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).

  2. 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).

  3. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.