Skin Tape Transcriptome Methods in Children

NCT ID: NCT04180644

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2020-02-05

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Atopic Dermatitis

Participants with atopic dermatitis active lesions

Skin tape strips

Intervention Type: 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.

Healthy Control

Participants without a history of atopic dermatitis

Skin tape strips

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Jewish Health and University of Colorado Denver

Denver, Colorado, United States

Countries

United States

Other Identifiers

HS-3484

Identifier Type: -

Identifier Source: org_study_id