Dermatologic DiseasesNCT04668846
A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
An observational study of Dermatologic Diseases, run by DermTech at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dermatologic Diseases
- What is being tested?
- non-invasive sample collection of skin tissue
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Males and females at least 21 years of age;
- 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;
- Willing to allow additional DermTech adhesive patch biopsies to be performed; and
- Willing to provide informed consent to participate in this trial.
Who cannot join
- 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, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Skin Care Research, LLC
Boca Raton, Florida, 33486
Lori Aptekar, MBA, 561-948-3116, Lori.Aptekar.SCR@gmail.com
- Recruiting
Elizabeth S. Robinson, MD
Denver, Colorado, 80237
Elizabeth S Robinson, MD, 303-850-9715, robinson.liz@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dermatologic Diseases
- Being tested
- non-invasive sample collection of skin tissue
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive sample collection of skin tissueOther
Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dermatologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermTech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Rock, MS, Study director, DermTech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668846
- Sponsor's protocol ID
- 17-06
- Status last verified
- Mar 2022
- First submitted
- 8 Dec 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29036251Krueger G, Jansen B, Yao Z. Non-Invasive Gene Expression Analysis Assay for Psoriasis. Poster Presentation American Academy of Dermatology. March 2017.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits in Subjects With a Variety of Dermatologic Conditions
- ClinicalTrials.gov ID
- NCT04668846
- Acronym / sponsor ID
- 17-06
- Conditions
- Dermatologic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- DermTechUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Males and females at least 21 years of age;
- 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;
- Willing to allow additional DermTech adhesive patch biopsies to be performed; and
- Willing to provide informed consent to participate in this trial.
Key exclusion criteria (5 listed)
- 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, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive sample collection of skin tissueBoth lesional and non-lesional skin will be sampled with up to 24 adhesive patches. | Other | – |
Primary outcome
Gene Expression Analysis
Time frame: 24 months
To collect skin tissue from subjects with a variety of dermatologic conditions, both lesional and non-lesional areas to analyze for unique gene signatures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 29036251Yao 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.
- BackgroundKrueger G, Jansen B, Yao Z. Non-Invasive Gene Expression Analysis Assay for Psoriasis. Poster Presentation American Academy of Dermatology. March 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Rock, MS study director
DermTech
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Diseases, run by DermTech at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Rock (18582052736, jrock@dermtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Analysis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04668846, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.