NCT04668846

Brief Summary

This sample collection study will recruit subjects with a variety of skin conditions from up to 15 geographically dispersed sites in the United States. Skin samples will be collected with the DermTech Adhesive Patch Kit from both lesional and non-lesional skin. Subjects may also be asked to return at a future data for additional collections. Collected skin samples will be analyzed for gene expression information, DNA and the microbiome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

July 26, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

December 8, 2020

Last Update Submit

July 25, 2022

Conditions

Dermatologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Gene Expression Analysis

    To collect skin tissue from subjects with a variety of dermatologic conditions, both lesional and non-lesional areas to analyze for unique gene signatures

    24 months

Interventions

non-invasive sample collection of skin tissueOTHER

Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a variety of dermatologic conditions will have both lesional and non-lesional skin collected using the DermTech non-invasive adhesive patch kit. Dermatologic conditions include but are not limited too; atopic dermatitis, atopic asthma, skin cancers (i.e., basal, and squamous carcinoma, melanoma, etc.), lupus, rheumatoid and psoriatic arthritis, gutate and plaque psoriasis, palmoplantar psoriasis, palmoplantar contact dermatitis, fungal infections and cutaneous T cell Lymphoma

You may qualify if:

  • Males and females at least 21 years of age;
  • Have a dermatologic condition of interesting including but not limited too; atopic dermatitis, atopic asthma, skin cancers (i.e., basal, and squamous carcinoma, melanoma, etc.), lupus, rheumatoid and psoriatic arthritis, gutate and plaque psoriasis, palmoplantar psoriasis, palmoplantar contact dermatitis, fungal infections and cutaneous T cell Lymphoma that can be non-invasively biopsied with DermTech's adhesive patch kit;
  • Willing to allow additional DermTech adhesive patch biopsies to be performed; and
  • Willing to provide informed consent to participate in this trial.

You may not qualify if:

  • Required a surgical biopsy or excision prior to a PLA on that lesion of interest;
  • Has an ulcerated or bleeding lesion that could cofound the PLA results;
  • Has a suspicious lesion(s) in an area that was previously surgically biopsied;
  • Has an allergy to tape or latex rubber; and
  • Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elizabeth S. Robinson, MD

Denver, Colorado, 80237, United States

RECRUITING

Skin Care Research, LLC

Boca Raton, Florida, 33486, United States

RECRUITING

Related Publications (2)

  • Yao Z, Moy R, Allen T, Jansen B. An Adhesive Patch-Based Skin Biopsy Device for Molecular Diagnostics and Skin Microbiome Studies. J Drugs Dermatol. 2017 Oct 1;16(10):979-986.

    PMID: 29036251BACKGROUND

  • Krueger G, Jansen B, Yao Z. Non-Invasive Gene Expression Analysis Assay for Psoriasis. Poster Presentation American Academy of Dermatology. March 2017.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Non-invasive collected skin samples will be collected and banked for future analysis.

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • James Rock, MS

    DermTech

    STUDY DIRECTOR

Central Study Contacts

James Rock

CONTACT

18582052736jrock@dermtech.com

Susan Huynh

CONTACT

8584504222susan.huynh@dermtech.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 16, 2020

Study Start

October 1, 2020

Primary Completion

October 30, 2023

Study Completion

December 15, 2023

Last Updated

July 26, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)