Skin Tape Transcriptome Methods in Children

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180644
• Other study ID #: HS-3484
• Status: Completed
• Start date: January 10, 2020
• Est. completion date: February 5, 2020

Study information

• Verified date: April 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	National Jewish Health and University of Colorado Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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