Atopic DermatitisNCT06934980
A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis Participants
An observational study of Atopic Dermatitis and Healthy Volunteers, run by Incyte Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate microneedle-based collection of dermal interstitial skin fluid (dISF) in healthy participants and atopic dermatitis (AD) participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Healthy Volunteers
- What is being tested?
- Microneedle Device
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2025to 19 Dec 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 5 healthy participants and approximately 10 to 15 participants with mild to severe AD will be enrolled.
Who may be able to join
- All Participants:
- Male or female participant aged 18 to 65 years (inclusive) at the time of consent.
- Female participant of childbearing potential has a negative urine pregnancy test at screening and Day 1.
- Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
- Participants must be willing and able to comply with all study procedures and must be available for the duration of the study.
- Healthy Participants:
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- Participant is in good general health, according to the investigator's judgment based on medical and surgical history and skin examination.
- Participant has no known prior history of autoimmune inflammatory skin conditions.
- Participants with AD:
- Participant has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
- Participant has at least 2 years history of AD (information obtained from medical chart or participant's physician, or directly from the participant) and had no significant flares in AD for at least 4 weeks before screening according to investigators judgement.
- Participant has mild to severe AD at screening and Day 1, as defined by an IGA ≥ 2.
- Participant has AD covering ≥ 3% of the BSA (excluding palms, soles, scalp, genitals, and folds) at screening and Day 1.
- Participant has ≥ 2 target lesions with a TLSS score ≥ 6 at screening and Day 1 (Lesion Sites #1 and #2) with a lesional surface allowing the collection of all required biospecimens. The difference in TLSS between the 2 target lesions must not be > 1.
- Note 1: A participant who does not have a Lesion Site #2 with a lesional surface that could accommodate all biospecimens collection may be enrolled in the study if he/she has individual AD lesions (collectively referred to as Lesion Site #2) amenable to sample collection that have (1) an overall surface to accommodate all biospecimens collection, (2) identical TLSS scores, and are (3) from the same anatomical region.
- Note 2: Every effort should be made to collect all required biospecimens at Lesion Site #2. However, if lesional size does not allow, the tape strip sample may not be collected. A minimum of 8 patients with AD should undergo tape strip sample collection at Lesion Site #2.
Who cannot join
- All Participants:
- Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Participant is known to have immune deficiency or is immunocompromized.
- Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
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- Participant has received an investigational product or device within 4 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
- Participant has a presence of any tattoos, scratches, open sores, excessive hair, or skin damage that, in the opinion of the investigator, may interfere with study evaluations.
- Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements.
- Participant has a close affiliation (eg, a close relative) with the investigator, including any study staff of the sites or persons working at the contract research organization, or participant is an employee of the sponsor.
- Participant has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
- Participant has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1. Use of sunscreen products and protective apparel are recommended when sun exposure cannot be avoided.
- Participant is institutionalized because of legal or regulatory order.
- Participant has used any topical product in the sampling area prior to the visit on Day 1.
- Participant has received a live or live-attenuated vaccine within 4 weeks prior to Day 1.
- Healthy Participants:
- Participant has used topical medication (prescription or over-the-counter [OTC]) in the sampling area within 2 weeks prior to Day 1.
- Participant has used prescription immunosuppressive or immunomodulatory drugs within 4 weeks prior to Day 1.
- Participants with AD:
- Participant has clinically infected AD.
- Participant has any clinically significant medical condition abnormality (based on medical and surgical history and skin examination) that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.
- Participant has used doxepin within 1 week prior to Day 1.
- Participant has used hydroxyzine or diphenhydramine within 1 week prior to Day 1.
- Participant has used topical products containing urea within 1 week prior to Day 1.
- Participant has used systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Day 1.
- Participant has used any topical medicated treatment that could affect AD within 1 week prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole, calcineurin inhibitors, ruxolitinib, tars, antimicrobials, medical devices, and bleach baths.
- Participant has used systemic treatments (other than biologics) that could affect AD less than 4 weeks prior to Day 1, including, but not limited to, retinoids, calcineurin inhibitors, methotrexate, cyclosporine, azathioprine, oral/injectable corticosteroids, baricitinib, upadacitinib, and abrocitinib.
- Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
- Participant has received any ultraviolet (UV)-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
- Participant has had psoralen-UV-A (PUVA) treatment within 4 weeks prior to Day 1.
- Participant has received any marketed (eg, dupilumab, tralokinumab, lebrikizumab) or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
- Participant has received an intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Day 1.
- Participant has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
- Participant has a history of hypertrophic scarring or keloid formation in scars or suture sites.
- Participant has taken anticoagulant medication, such as heparin, low molecular weight (LMW)-heparin, warfarin, antiplatelets (except low-dose aspirin ≤ 81 mg which will be allowed), within 2 weeks prior to Day 1, or has a contraindication to skin biopsies. Nonsteroidal anti-inflammatory drugs (NSAIDs) will not be considered antiplatelets and will be allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 0, EVALUATION OF MICRONEEDLE-BASED COLLECTION OF DERMAL INTERSTITIAL SKIN FLUID IN HEALTHY PARTICIPANTS AND ATOPIC DERMATITIS PATIENTS
The purpose of this study is to evaluate microneedle-based collection of dermal interstitial skin fluid (dISF) in healthy participants and atopic dermatitis (AD) participants
- Conditions
- Atopic Dermatitis, Healthy Volunteers
- Being tested
- Microneedle Device
- Keywords
- Microneedle Device
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle DeviceDevice
Microneedle device will be used for collecting dermal interstitial skin fluid samples as defined by the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Microneedle device samples will be collected as defined in the protocol as a non-invasive method. Receives: Device: Microneedle Device | |
| Participants with Atopic Dermatitis (AD) | Microneedle device samples will be collected as defined in the protocol as a non-invasive method. Receives: Device: Microneedle Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of dISF collected from normal skin in healthy participants and lesional skin from AD patients
Measured: Day 1
Secondary outcomes (4)
Incidence and severity of procedural complications
Defined using the Investigator Global Assessment Scale.
Measured: Up to 14 days
Willingness for repeat sample collection
Defined using a 5- point likert scale questionnaire.
Measured: Day 1
Tolerability of dISF collection and other sampling techniques
Defined using the Local Skin Tolerability Scale.
Measured: Day 1
Tolerability of a single and two consecutive dISF sample collection in a single day
Defined using the Local Skin Tolerability Scale.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start27 Jun 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934980
- Sponsor's protocol ID
- INCB000000-002
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 0, EVALUATION OF MICRONEEDLE-BASED COLLECTION OF DERMAL INTERSTITIAL SKIN FLUID IN HEALTHY PARTICIPANTS AND ATOPIC DERMATITIS PATIENTS
- ClinicalTrials.gov ID
- NCT06934980
- Acronym / sponsor ID
- INCB000000-002
- Conditions
- Atopic Dermatitis, Healthy Volunteers
- Keywords
- Microneedle Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 18 Apr 2025 (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.
The purpose of this study is to evaluate microneedle-based collection of dermal interstitial skin fluid (dISF) in healthy participants and atopic dermatitis (AD) participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Microneedle DeviceMicroneedle device samples will be collected as defined in the protocol as a non-invasive method. |
| Participants with Atopic Dermatitis (AD) | – | Device: Microneedle DeviceMicroneedle device samples will be collected as defined in the protocol as a non-invasive method. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 5 healthy participants and approximately 10 to 15 participants with mild to severe AD will be enrolled.
Key inclusion criteria (16 listed)
- Male or female participant aged 18 to 65 years (inclusive) at the time of consent.
- Female participant of childbearing potential has a negative urine pregnancy test at screening and Day 1.
- Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
- Participants must be willing and able to comply with all study procedures and must be available for the duration of the study.
- Participant is in good general health, according to the investigator's judgment based on medical and surgical history and skin examination.
Key exclusion criteria (36 listed)
- Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- Participant is known to have immune deficiency or is immunocompromized.
- Participant has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Participants with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
- Participant had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
- Participant has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
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 |
|---|---|---|
| Microneedle DeviceMicroneedle device will be used for collecting dermal interstitial skin fluid samples as defined by the protocol. | Device | Healthy Volunteers, Participants with Atopic Dermatitis (AD) |
Primary outcome
Volume of dISF collected from normal skin in healthy participants and lesional skin from AD patients
Time frame: Day 1
4 secondary outcomes
Incidence and severity of procedural complications
Time frame: Up to 14 days
Willingness for repeat sample collection
Time frame: Day 1
Tolerability of dISF collection and other sampling techniques
Time frame: Day 1
Tolerability of a single and two consecutive dISF sample collection in a single day
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis ParticipantsLink provided by the sponsor.
- 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.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Healthy Volunteers, run by Incyte Corporation at 1 site in Canada.
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 16 inclusion and 36 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of dISF collected from normal skin in healthy participants and lesional skin from AD patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.