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

Irritant Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231813
• Other study ID #: 003-08/17-03/0001
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: September 28, 2017
• Start date: August 29, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: June 2017
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Irritant Contact Dermatitis

Intervention

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.

Locations

Country	Name	City	State
Croatia	School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (23)

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Breternitz M, Flach M, Prässler J, Elsner P, Fluhr JW. Acute barrier disruption by adhesive tapes is influenced by pressure, time and anatomical location: integrity and cohesion assessed by sequential tape stripping. A randomized, controlled study. Br J Dermatol. 2007 Feb;156(2):231-40. — View Citation

Cua AB, Wilhelm KP, Maibach HI. Cutaneous sodium lauryl sulphate irritation potential: age and regional variability. Br J Dermatol. 1990 Nov;123(5):607-13. — View Citation

Cua AB, Wilhelm KP, Maibach HI. Frictional properties of human skin: relation to age, sex and anatomical region, stratum corneum hydration and transepidermal water loss. Br J Dermatol. 1990 Oct;123(4):473-9. — View Citation

Darlenski R, Fluhr JW. Influence of skin type, race, sex, and anatomic location on epidermal barrier function. Clin Dermatol. 2012 May-Jun;30(3):269-73. doi: 10.1016/j.clindermatol.2011.08.013. — View Citation

Emtestam L, Ollmar S. Electrical impedance index in human skin: measurements after occlusion, in 5 anatomical regions and in mild irritant contact dermatitis. Contact Dermatitis. 1993 Feb;28(2):104-8. — View Citation

Feldmann RJ, Maibach HI. Regional variation in percutaneous penetration of 14C cortisol in man. J Invest Dermatol. 1967 Feb;48(2):181-3. — View Citation

Fluhr JW, Dickel H, Kuss O, Weyher I, Diepgen TL, Berardesca E. Impact of anatomical location on barrier recovery, surface pH and stratum corneum hydration after acute barrier disruption. Br J Dermatol. 2002 May;146(5):770-6. — View Citation

Hadgraft J, Lane ME. Transepidermal water loss and skin site: a hypothesis. Int J Pharm. 2009 May 21;373(1-2):1-3. doi: 10.1016/j.ijpharm.2009.02.007. Epub 2009 Feb 21. — View Citation

Holbrook KA, Odland GF. Regional differences in the thickness (cell layers) of the human stratum corneum: an ultrastructural analysis. J Invest Dermatol. 1974 Apr;62(4):415-22. — View Citation

Kleesz P, Darlenski R, Fluhr JW. Full-body skin mapping for six biophysical parameters: baseline values at 16 anatomical sites in 125 human subjects. Skin Pharmacol Physiol. 2012;25(1):25-33. doi: 10.1159/000330721. Epub 2011 Sep 7. — View Citation

Lavrijsen AP, Geelen FA, Oestmann E, Hermans J, Bodda HE, Ponec M. Comparison of human back versus arm skin region for its suitability to test weak irritants. Skin Res Technol. 1996 May;2(2):70-7. doi: 10.1111/j.1600-0846.1996.tb00062.x. — View Citation

Lee CH, Maibach HI. The sodium lauryl sulfate model: an overview. Contact Dermatitis. 1995 Jul;33(1):1-7. Review. — View Citation

Machado M, Salgado TM, Hadgraft J, Lane ME. The relationship between transepidermal water loss and skin permeability. Int J Pharm. 2010 Jan 15;384(1-2):73-7. doi: 10.1016/j.ijpharm.2009.09.044. Epub 2009 Sep 30. — View Citation

Magnusson B, Hersle K. Patch test methods. II. Regional variations of patch test responses. Acta Derm Venereol. 1965;45(4):257-61. — View Citation

Nedelec B, Forget NJ, Hurtubise T, Cimino S, de Muszka F, Legault A, Liu WL, de Oliveira A, Calva V, Correa JA. Skin characteristics: normative data for elasticity, erythema, melanin, and thickness at 16 different anatomical locations. Skin Res Technol. 2016 Aug;22(3):263-75. doi: 10.1111/srt.12256. Epub 2015 Sep 1. — View Citation

Rougier A, Dupuis D, Lotte C, Roguet R, Wester RC, Maibach HI. Regional variation in percutaneous absorption in man: measurement by the stripping method. Arch Dermatol Res. 1986;278(6):465-9. — View Citation

Rougier A, Lotte C, Maibach HI. In vivo percutaneous penetration of some organic compounds related to anatomic site in humans: predictive assessment by the stripping method. J Pharm Sci. 1987 Jun;76(6):451-4. — View Citation

Schwindt DA, Wilhelm KP, Maibach HI. Water diffusion characteristics of human stratum corneum at different anatomical sites in vivo. J Invest Dermatol. 1998 Sep;111(3):385-9. — View Citation

Tagami H. Location-related differences in structure and function of the stratum corneum with special emphasis on those of the facial skin. Int J Cosmet Sci. 2008 Dec;30(6):413-34. doi: 10.1111/j.1468-2494.2008.00459.x. Review. — View Citation

Tupker RA, Willis C, Berardesca E, Lee CH, Fartasch M, Agner T, Serup J. Guidelines on sodium lauryl sulfate (SLS) exposure tests. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1997 Aug;37(2):53-69. — View Citation

Wilhelm KP, Cua AB, Maibach HI. Skin aging. Effect on transepidermal water loss, stratum corneum hydration, skin surface pH, and casual sebum content. Arch Dermatol. 1991 Dec;127(12):1806-9. — View Citation

Ya-Xian Z, Suetake T, Tagami H. Number of cell layers of the stratum corneum in normal skin - relationship to the anatomical location on the body, age, sex and physical parameters. Arch Dermatol Res. 1999 Oct;291(10):555-9. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss	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
Primary	Stratum corneum hydration	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
Primary	Erythema	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	Clinical score	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