Skin Tape Transcriptome Methods in Children

Sponsor
National Jewish Health (Other)
Overall Status
Completed
CT.gov ID
NCT04180644
Collaborator
(none)
20
1
26
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Skin tape strips

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Novel Skin Tape Transcriptome Methods in Children With Atopic Dermatitis and Healthy Controls
Actual Study Start Date :
Jan 10, 2020
Actual Primary Completion Date :
Feb 5, 2020
Actual Study Completion Date :
Feb 5, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. skin RNA sequence for (lesional (L) and non-lesional (NL)) Skin Tape Strips (STS) [through study completion, single visit with an average of 2 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

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

OR

  1. .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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Jewish Health and University of Colorado Denver Denver Colorado United States 80206

Sponsors and Collaborators

  • National Jewish Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT04180644
Other Study ID Numbers:
  • HS-3484
First Posted:
Nov 27, 2019
Last Update Posted:
Apr 13, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2020