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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLS irritation model and Treatment | Experimental | SLS induced irritation on two sites each on forearms and back Emollient cream treatment |
|
| SLS irritation model and No Treatment | Placebo Comparator | SLS induced irritation on two sites each on forearms and back No treatment |
|
| Sham irritation and Treatment | Sham Comparator | Sham irritation (water) on two sites each on forearms and back Emollient cream treatment |
|
| Sham irritation and No Treatment | No Intervention | Sham irritation (water) on two sites each on forearms and back No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dario Leskur, MPharm | University of Split, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine | Split | 21000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9285167 | Background | 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. doi: 10.1111/j.1600-0536.1997.tb00041.x. | |
| 1845280 | Background |
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| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004643 | Emollients |
| ID | Term |
|---|---|
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Emollient, moisturizing cream | Other | Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol. |
|
| 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. |
| 9740228 | 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. |
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| 19429281 | 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. |
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| 17223861 | 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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| 3625489 | 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. |
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| 30637727 | Derived | 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. |
| D017443 |
| Skin Diseases, Eczematous |