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Trial record 4 of 49 for:    Sodium Lauryl Sulfate

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

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ClinicalTrials.gov Identifier: NCT03231813
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Split, School of Medicine

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.


Condition or disease Intervention/treatment Phase
Irritant Contact Dermatitis Procedure: Sodium lauryl sulphate induced irritation Other: Emollient, moisturizing cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery: A Randomised, Controlled Trial
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : September 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLS irritation model and Treatment
SLS induced irritation on two sites each on forearms and back Emollient cream treatment
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.

Placebo Comparator: SLS irritation model and No Treatment
SLS induced irritation on two sites each on forearms and back No treatment
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.

Sham Comparator: Sham irritation and Treatment
Sham irritation (water) on two sites each on forearms and back Emollient cream treatment
Other: Emollient, moisturizing cream
Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.

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



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Clinical score [ Time Frame: Five assessments: baseline, irritation, first, third and ninth day of treatment ]
    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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231813


Locations
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Croatia
School of Medicine
Split, Croatia, 21000
Sponsors and Collaborators
University of Split, School of Medicine
Investigators
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Principal Investigator: Dario Leskur, MPharm University of Split, School of Medicine

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03231813     History of Changes
Other Study ID Numbers: 003-08/17-03/0001
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Split, School of Medicine:
irritant contact dermatitis
sodium lauryl sulphate
emollients
transepidermal water loss
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Irritant
Skin Diseases
Skin Diseases, Eczematous
Emollients
Dermatologic Agents