Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
Primary Purpose
Irritant Contact Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Sodium lauryl sulphate induced irritation
Emollient, moisturizing cream
Sponsored by
About this trial
This is an interventional other trial for Irritant Contact Dermatitis focused on measuring irritant contact dermatitis, sodium lauryl sulphate, emollients, transepidermal water loss
Eligibility Criteria
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
Sites / Locations
- School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Sham Comparator
No Intervention
Arm Label
SLS irritation model and Treatment
SLS irritation model and No Treatment
Sham irritation and Treatment
Sham irritation and No Treatment
Arm Description
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
SLS induced irritation on two sites each on forearms and back No treatment
Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
Sham irritation (water) on two sites each on forearms and back No treatment
Outcomes
Primary Outcome Measures
Transepidermal water loss
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Stratum corneum hydration
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Erythema
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03231813
First Posted
July 24, 2017
Last Updated
September 28, 2017
Sponsor
University of Split, School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03231813
Brief Title
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
Official Title
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Split, School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritant Contact Dermatitis
Keywords
irritant contact dermatitis, sodium lauryl sulphate, emollients, transepidermal water loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLS irritation model and Treatment
Arm Type
Experimental
Arm Description
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
Arm Title
SLS irritation model and No Treatment
Arm Type
Placebo Comparator
Arm Description
SLS induced irritation on two sites each on forearms and back No treatment
Arm Title
Sham irritation and Treatment
Arm Type
Sham Comparator
Arm Description
Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
Arm Title
Sham irritation and No Treatment
Arm Type
No Intervention
Arm Description
Sham irritation (water) on two sites each on forearms and back No treatment
Intervention Type
Procedure
Intervention Name(s)
Sodium lauryl sulphate induced irritation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Emollient, moisturizing cream
Intervention Description
Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
Primary Outcome Measure Information:
Title
Transepidermal water loss
Description
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Time Frame
Five measurements; baseline, irritation, first, third and ninth day of treatment
Title
Stratum corneum hydration
Description
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Time Frame
Five measurements; baseline, irritation, first, third and ninth day of treatment
Title
Erythema
Description
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Time Frame
Five measurements; baseline, irritation, first, third and ninth day of treatment
Secondary Outcome Measure Information:
Title
Clinical score
Description
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.
Time Frame
Five assessments: baseline, irritation, first, third and ninth day of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Leskur, MPharm
Organizational Affiliation
University of Split, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Medicine
City
Split
ZIP/Postal Code
21000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9285167
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. doi: 10.1111/j.1600-0536.1997.tb00041.x.
Results Reference
background
PubMed Identifier
1845280
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. doi: 10.1001/archderm.127.12.1806.
Results Reference
background
PubMed Identifier
9740228
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. doi: 10.1046/j.1523-1747.1998.00321.x.
Results Reference
background
PubMed Identifier
7493454
Citation
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.
Results Reference
background
PubMed Identifier
19099543
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.
Results Reference
background
PubMed Identifier
26333046
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.
Results Reference
background
PubMed Identifier
22507039
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.
Results Reference
background
PubMed Identifier
7867323
Citation
Berardesca E, Distante F. The modulation of skin irritation. Contact Dermatitis. 1994 Nov;31(5):281-7. doi: 10.1111/j.1600-0536.1994.tb02019.x.
Results Reference
background
PubMed Identifier
8458202
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. doi: 10.1111/j.1600-0536.1993.tb03352.x.
Results Reference
background
PubMed Identifier
2095179
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. doi: 10.1111/j.1365-2133.1990.tb01452.x.
Results Reference
background
PubMed Identifier
21912200
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.
Results Reference
background
PubMed Identifier
27327221
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.
Results Reference
background
PubMed Identifier
4820685
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. doi: 10.1111/1523-1747.ep12701670. No abstract available.
Results Reference
background
PubMed Identifier
19429281
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.
Results Reference
background
PubMed Identifier
10552214
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. doi: 10.1007/s004030050453.
Results Reference
background
PubMed Identifier
12000372
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. doi: 10.1046/j.1365-2133.2002.04695.x.
Results Reference
background
PubMed Identifier
17223861
Citation
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.
Results Reference
background
PubMed Identifier
4162958
Citation
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.
Results Reference
background
PubMed Identifier
2248890
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. doi: 10.1111/j.1365-2133.1990.tb01477.x.
Results Reference
background
PubMed Identifier
6020682
Citation
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.
Results Reference
background
PubMed Identifier
3789805
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. doi: 10.1007/BF00455165.
Results Reference
background
PubMed Identifier
3625489
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. doi: 10.1002/jps.2600760608.
Results Reference
background
PubMed Identifier
19799976
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.
Results Reference
background
PubMed Identifier
30637727
Citation
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.
Results Reference
derived
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Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
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