Recruiting

Observational Study

Sponsor:

DermTech

Code:

NCT04668846

Conditions

Dermatologic Diseases

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

non-invasive sample collection of skin tissue

Study Details

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.

Conditions

Dermatologic Diseases

Study ID

NCT04668846

Start date

Oct 1, 2020

Status verified date

Mar, 2022

Completion date

Dec 15, 2023

Anticipated

Primary completion date

Oct 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

non-invasive sample collection of skin tissue

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

Primary outcome measure

  • Gene Expression Analysis [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

Elizabeth S. Robinson, MD

Recruiting

Denver, Colorado, United States, 80237

Contacts

Elizabeth S Robinson, MD

303-850-9715robinson.liz@gmail.com

Skin Care Research, LLC

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

More Information

Sponsor

DermTech

Last update posted

Jul 26, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DermTech on 2022-07-26.