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

NCT03231813 | Completed

• 1 other identifier: 003-08/17-03/0001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritant Contact Dermatitis

Keywords

irritant contact dermatitis; sodium lauryl sulphate; emollients; transepidermal water loss

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Clinical score

  Five assessments: baseline, irritation, first, third and ninth day of treatment

Study Arms (4)

SLS irritation model and Treatment

EXPERIMENTAL

SLS induced irritation on two sites each on forearms and back Emollient cream treatment

Procedure: Sodium lauryl sulphate induced irritation; Other: Emollient, moisturizing cream

SLS irritation model and No Treatment

PLACEBO COMPARATOR

SLS induced irritation on two sites each on forearms and back No treatment

Procedure: Sodium lauryl sulphate induced irritation

Sham irritation and Treatment

SHAM COMPARATOR

Sham irritation (water) on two sites each on forearms and back Emollient cream treatment

Other: Emollient, moisturizing cream

Sham irritation and No Treatment

NO INTERVENTION

Sham irritation (water) on two sites each on forearms and back No treatment

Interventions

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.

SLS irritation model and No Treatment; SLS irritation model and Treatment

Emollient, moisturizing cream OTHER

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

SLS irritation model and Treatment; Sham irritation and Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• young, healthy volunteers who gave written informed consent

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

School of Medicine

Split, 21000, Croatia

Location

Related Publications (24)

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  PMID: 9285167 BACKGROUND

• 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. doi: 10.1001/archderm.127.12.1806.

  PMID: 1845280 BACKGROUND

• 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. doi: 10.1046/j.1523-1747.1998.00321.x.

  PMID: 9740228 BACKGROUND

• Lee CH, Maibach HI. The sodium lauryl sulfate model: an overview. Contact Dermatitis. 1995 Jul;33(1):1-7. doi: 10.1111/j.1600-0536.1995.tb00438.x.

  PMID: 7493454 BACKGROUND

• 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.

  PMID: 19099543 BACKGROUND

• 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.

  PMID: 26333046 BACKGROUND

• 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.

  PMID: 22507039 BACKGROUND

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  PMID: 7867323 BACKGROUND

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  PMID: 8458202 BACKGROUND

• 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. doi: 10.1111/j.1365-2133.1990.tb01452.x.

  PMID: 2095179 BACKGROUND

• 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.

  PMID: 21912200 BACKGROUND

• 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.

  PMID: 27327221 BACKGROUND

• 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. doi: 10.1111/1523-1747.ep12701670. No abstract available.

  PMID: 4820685 BACKGROUND

• 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.

  PMID: 19429281 BACKGROUND

• 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. doi: 10.1007/s004030050453.

  PMID: 10552214 BACKGROUND

• 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. doi: 10.1046/j.1365-2133.2002.04695.x.

  PMID: 12000372 BACKGROUND

• Breternitz M, Flach M, Prassler 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. doi: 10.1111/j.1365-2133.2006.07632.x.

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• Magnusson B, Hersle K. Patch test methods. II. Regional variations of patch test responses. Acta Derm Venereol. 1965;45(4):257-61. No abstract available.

  PMID: 4162958 BACKGROUND

• 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. doi: 10.1111/j.1365-2133.1990.tb01477.x.

  PMID: 2248890 BACKGROUND

• Feldmann RJ, Maibach HI. Regional variation in percutaneous penetration of 14C cortisol in man. J Invest Dermatol. 1967 Feb;48(2):181-3. doi: 10.1038/jid.1967.29. No abstract available.

  PMID: 6020682 BACKGROUND

• 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. doi: 10.1007/BF00455165.

  PMID: 3789805 BACKGROUND

• 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. doi: 10.1002/jps.2600760608.

  PMID: 3625489 BACKGROUND

• 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.

  PMID: 19799976 BACKGROUND

• Leskur D, Bukic J, Petric A, Zekan L, Rusic D, Seselja Perisin A, Petric I, Stipic M, Puizina-Ivic N, Modun D. Anatomical site differences of sodium lauryl sulfate-induced irritation: randomized controlled trial. Br J Dermatol. 2019 Jul;181(1):175-185. doi: 10.1111/bjd.17633. Epub 2019 Apr 11.

  PMID: 30637727 DERIVED

MeSH Terms

Conditions

Dermatitis, Irritant

Interventions

Emollients

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dario Leskur, MPharm

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 27, 2017
• Study Start: August 29, 2017
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-06

Locations

CR (1)