Clinical trial NCT04668846: A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
Official title: A Multicenter Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits in Subjects With a Variety of Dermatologic Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatologic Diseases
Lead sponsor: DermTech
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gene Expression Analysis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Elizabeth S. Robinson, MD
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
Study officials:
affiliation: DermTech
name: James Rock, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Krueger G, Jansen B, Yao Z. Non-Invasive Gene Expression Analysis Assay for Psoriasis. Poster Presentation American Academy of Dermatology. March 2017.