Defining the Skin and Blood Biomarkers of Ichthyosis

STATUS

Recruiting
End date

Dec 31, 2023
participants needed

200
sponsor

Northwestern University

Updated on 19 April 2022

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Accepts healthy volunteers

Summary

Ichthyosis is a group of genetic skin disorders that present with dry, thickened, scaly, or flaky skin. As of today, there is no cure or treatment. Doctors can only treat the dry skin with different types of emollients to soften the scale. A deeper understanding of this disease is required to develop better treatments. There are different types of cells and cell-produced signals (biomarkers) that are being studied in order to help find these new treatments. Looking at biomarkers has been successful in helping us to understand other skin disorders better. The purpose of this study is to determine which blood and skin biomarkers characterize ichthyosis.

Hypothesis: We predict that the biomarkers correlating with disease activity in Netherton syndrome will be different than the biomarkers found to correlate with the lamellar and other ichthyosis phenotype.

Description

Objectives

To define a panel of skin and blood biomarkers associated with disease activity and pruritus in Netherton syndrome, lamellar ichthyosis, and other ichthyosis subtypes.
To determine if blood samples can serve as surrogates for skin immune activation and will correlate with disease severity.
To determine FLG, SPINK5, TGM1, or other mutation via buccal/saliva samples in ichthyosis subjects
To determine differences in alterations of epidermal lipids and proteins in the outer stratum corneum of epidermis collected from tape strips in patients with ichthyosis compared to the general population. There will also be a difference detected in epidermal lipids from blood samples.

Details

Condition	Ichthyosis, Netherton Syndrome
Clinical Study Identifier	NCT03417856
Sponsor	Northwestern University
Last Modified on	19 April 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Control and ichthyosis subjects may be of either sex and must be between 1-60 years of age at the time of enrollment
	Ichthyosis subjects include individuals with a diagnosis Netherton syndrome, lamellar ichthyosis, or other ichthyosis subtypes
	Ichthyosis subjects should not have administered systemic immunosuppressant therapy in the month before the study
	Ichthyosis subjects should not use topical immunosuppressants in the week before the study
	Ichthyosis subjects should not have applied emollients to the planned biopsy sites within 12 hours before biopsy, but can be applied elsewhere
	Controls may have no inflammatory disease, atopy, or obvious xerosis (urticaria, food allergy, allergic rhinitis or conjunctivitis, asthma)
	Controls for skin sampling may have no observable abnormality in the sampled skin and, to further assure the normality of the "normal" skin edges, must not have evidence of inflammation or epidermal change in the lesion to be surgically removed
	Subjects and guardians of minors must sign the approved IRB consent form(s) prior to initiation of the study protocol
Exclusion Criteria
	Subjects who are unable to give informed consent or assent
	Subjects who administered anti-inflammatory systemic and topical therapy or emollients that do not comply with inclusion criteria prior to blood and biopsy sampling
	Subjects whose main diagnosis is deemed unsafe by the study investigator for study participation

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Defining the Skin and Blood Biomarkers of Ichthyosis