A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

A Multicenter Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits in Subjects With a Variety of Dermatologic Conditions

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatologic Diseases
• Intervention / Treatment: Other: non-invasive sample collection of skin tissue

Detailed Description

This is a multi-center, sample collection study to obtain skin tissue for gene expression, DNA mutation, microbiome and related analyses from subjects with dermatologic conditions. After subjects are consented for the study, site staff will collect skin tissue from the subject using DermTech's non-invasive skin collection kit. Skin samples will be collected from both lesional and non-lesional skin as applicable.

Additional skin tissue may be collected from the lesion and non-lesional area with the DermTech non-invasive skin collection kit at a later time point as directed by DermTech to track the dermatologic condition for progression, improvements or lack of response to standard of care therapy.

Each Dermtech non-invasive skin collection kit will consist of the sequential application of up to 24 individual patches to lesional and non-lesional areas. Sites should apply the DermTech patches to the most severe lesion(s).

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. Skin tissue will be collected using DermTech's proprietary adhesive patch skin biopsy kit and extracted for analysis at DermTech's CLIA and CAP Laboratory. Analysis of the samples will include gene expression signatures and DNA mutation as well as microbiome analyses associated with the medical conditions of interest.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80237
      • Recruiting
      • Elizabeth S. Robinson, MD
      • Contact: Elizabeth S Robinson, MD; Phone Number: 303-850-9715; Email: robinson.liz@gmail.com
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Skin Care Research, LLC
      • Contact: Lori Aptekar, MBA; Phone Number: 561-948-3116; Email: Lori.Aptekar.SCR@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

1. Males and females at least 21 years of age;
2. 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;
3. Willing to allow additional DermTech adhesive patch biopsies to be performed; and
4. Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

1. Required a surgical biopsy or excision prior to a PLA on that lesion of interest;
2. Has an ulcerated or bleeding lesion that could cofound the PLA results;
3. Has a suspicious lesion(s) in an area that was previously surgically biopsied;
4. Has an allergy to tape or latex rubber; and
5. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: DermTech
• Investigators: Study Director: James Rock, MS, DermTech

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 17-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No