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

Phase

N/A

Condition

Skin Conditions

Treatment

N/A

Clinical Study ID

NCT04668846

17-06

Ages > 21
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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, orconcurrent participation in another interventional clinical study deemed by thetreating physician to potentially influence this study.

Study Design

October 01, 2020

December 15, 2023

Study 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.

Connect with a study center

Elizabeth S. Robinson, MD
Denver, Colorado 80237
United States
Active - Recruiting
Skin Care Research, LLC
Boca Raton, Florida 33486
United States
Active - Recruiting

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