Skin Tape Transcriptome Methods in Children

National Jewish Health

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: Skin tape strips

Study type: Observational

Funder types: Other

Identifiers

NCT04180644

HS-3484

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Atopic Dermatitis

Description:

Participants with atopic dermatitis active lesions

Treatment:

Other: Skin tape strips

Healthy Control

Description:

Participants without a history of atopic dermatitis

Treatment:

Other: Skin tape strips