Skin Tape Transcriptome Methods in Children

Evaluation of Novel Skin Tape Transcriptome Methods in Children With Atopic Dermatitis and Healthy Controls

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Skin tape strips

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health and University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Able to provide informed consent/assent.
2. Male or female, 4-12 years of age (prepuberty) inclusive at the time of consenting

3. Participant must be either:

   1. Active atopic dermatitis with two areas of non-lesional AD within 5 cm of the measured lesional area within the same region.

      OR

   2. .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

Exclusion Criteria:

1. Unable to provide consent or comply with the protocol
2. 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)
3. History of any skin reaction to tape, or adhesives
4. 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.
5. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic Dermatitis; Participants with atopic dermatitis active lesions	Other: Skin tape strips; 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.
Healthy Control; Participants without a history of atopic dermatitis	Other: Skin tape strips; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: HS-3484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No