Skin Tape Transcriptome Methods in Children

NCT04180644 | Completed

• 1 other identifier: HS-3484
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate new methods for the collection, storage, shipment, and RNA extraction of skin tape specimens from children with atopic dermatitis (AD) that will facilitate the multi-center SunBeam Birth Cohort study. Additionally, this pilot study will test new methods for the generation of whole transcriptome sequencing data from skin tape RNA and whether these data reflect the transcriptional state of the skin in health and disease.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• skin RNA sequence for (lesional (L) and non-lesional (NL)) Skin Tape Strips (STS)

  the novel skin tape transcriptome method will extract RNA; the outcome is to identify the difference in RNA sequence between lesional and non-lesional skin.

  through study completion, single visit with an average of 2 hours

Study Arms (2)

Atopic Dermatitis

Participants with atopic dermatitis active lesions

Other: Skin tape strips

Healthy Control

Participants without a history of atopic dermatitis

Other: Skin tape strips

Interventions

Skin tape strips OTHER

Skin tape strips will be collected from lesional and non-lesional skin. Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. These discs will then be used to evaluate proteins and lipids in the upper layers of skin.

Atopic Dermatitis; Healthy Control

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit 20 children; 10 patients with moderate to severe AD and 10 healthy control subjects aged 4-12 (pre-puberty) years of age

You may qualify if:

• Able to provide informed consent/assent.
• Male or female, 4-12 years of age (prepuberty) inclusive at the time of consenting
• Participant must be either:
• Active atopic dermatitis with two areas of non-lesional AD within 5 cm of the measured lesional area within the same region.
• No personal history or current manifestations of AD, food allergy, asthma, allergic rhinitis, and no positive prick or blood testing for allergen (based on self-report); and no evidence of dry skin or other skin condition

You may not qualify if:

• Unable to provide consent or comply with the protocol
• Presence of any skin condition that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
• History of any skin reaction to tape, or adhesives
• Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on the area(s) to be tested within 24 hours before the study visit.

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health and University of Colorado Denver

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 27, 2019
• Study Start: January 10, 2020
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)