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

Dermatologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668846
• Other study ID #: 17-06
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2022
• Source: DermTech
• Contact: James Rock
• Phone: 18582052736
• Email: jrock[@]dermtech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 15, 2023
• Est. primary completion date: October 30, 2023
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatologic Diseases
• Skin Diseases

Intervention

Other:
• non-invasive sample collection of skin tissue
Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.

Locations

Country	Name	City	State
United States	Skin Care Research, LLC	Boca Raton	Florida
United States	Elizabeth S. Robinson, MD	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
DermTech

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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