Irritant Contact DermatitisNCT03231813
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery
A study testing Sodium lauryl sulphate induced irritation and Emollient, moisturizing cream in people with Irritant Contact Dermatitis, run by University of Split, School of Medicine at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritant Contact Dermatitis
- What is being tested?
- Sodium lauryl sulphate induced irritation and Emollient, moisturizing cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- 29 Aug 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young, healthy volunteers who gave written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
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.
Read more
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
- Being tested
- Sodium lauryl sulphate induced irritation, Emollient, moisturizing cream
- Keywords
- irritant contact dermatitis, sodium lauryl sulphate, emollients, transepidermal water loss
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium lauryl sulphate induced irritationProcedure or surgery
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 creamOther
Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
| Study group | Role | What they receive |
|---|---|---|
| SLS irritation model and Treatment | Experimental | SLS induced irritation on two sites each on forearms and back Emollient cream treatment Receives: 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 Receives: 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 Receives: Other: Emollient, moisturizing cream |
| Sham irritation and No Treatment | No intervention | Sham irritation (water) on two sites each on forearms and back No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/hm2).
Measured: 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).
Measured: 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).
Measured: Five measurements; baseline, irritation, first, third and ninth day of treatment
Secondary outcomes (1)
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.
Measured: Five assessments: baseline, irritation, first, third and ninth day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start29 Aug 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Irritant Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario Leskur, MPharm, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231813
- Sponsor's protocol ID
- 003-08/17-03/0001
- Status last verified
- Jun 2017
- First submitted
- 24 Jul 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9285167Wilhelm 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.
PubMed 1845280Schwindt 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.
PubMed 9740228Lee 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.
PubMed 7493454Tagami 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.
PubMed 19099543Nedelec 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.
PubMed 26333046Darlenski 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.
PubMed 22507039Berardesca 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.
PubMed 7867323Emtestam 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.
PubMed 8458202Cua 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.
PubMed 2095179Kleesz 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.
PubMed 21912200Lavrijsen 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.
PubMed 27327221Holbrook 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.
PubMed 4820685Hadgraft 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.
PubMed 19429281Ya-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.
PubMed 10552214
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT03231813
- Acronym / sponsor ID
- 003-08/17-03/0001
- Conditions
- Irritant Contact Dermatitis
- Keywords
- irritant contact dermatitis, sodium lauryl sulphate, emollients, transepidermal water loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SLS irritation model and Treatment | Experimental | Procedure: Sodium lauryl sulphate induced irritation, Other: Emollient, moisturizing creamSLS induced irritation on two sites each on forearms and back Emollient cream treatment |
| SLS irritation model and No Treatment | Placebo comparator | Procedure: Sodium lauryl sulphate induced irritationSLS induced irritation on two sites each on forearms and back No treatment |
| Sham irritation and Treatment | Sham comparator | Other: Emollient, moisturizing creamSham 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- young, healthy volunteers who gave written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium lauryl sulphate induced irritationSodium 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. | Procedure or surgery | SLS irritation model and No Treatment, SLS irritation model and Treatment |
| Emollient, moisturizing creamCommercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol. | Other | SLS irritation model and Treatment, Sham irritation and Treatment |
Primary outcome
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).
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).
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).
1 secondary outcome
Clinical score
Time frame: Five assessments: baseline, irritation, first, third and ninth day of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Background: PubMed 9285167Tupker 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.
- Background: PubMed 1845280Wilhelm 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.
- Background: PubMed 9740228Schwindt 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.
- Background: PubMed 7493454Lee 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.
- Background: PubMed 19099543Tagami 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.
- Background: PubMed 26333046Nedelec 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.
- Background: PubMed 22507039Darlenski 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.
- Background: PubMed 7867323Berardesca 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.
- Background: PubMed 8458202Emtestam 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.
- Background: PubMed 2095179Cua 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.
- Background: PubMed 21912200Kleesz 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.
- Background: PubMed 27327221Lavrijsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dario Leskur, MPharm principal investigator
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium lauryl sulphate induced irritation and Emollient, moisturizing cream in people with Irritant Contact Dermatitis, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss (time frame: Five measurements; baseline, irritation, first, third and ninth day of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231813, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.