A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis Participants

NCT06934980 | Completed FDA Device

• 1 other identifier: INCB000000-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atopic Dermatitis; Healthy Volunteers

Keywords

Microneedle Device

Outcome Measures

Primary Outcomes (1)

• Volume of dISF collected from normal skin in healthy participants and lesional skin from AD patients

  Day 1

Secondary Outcomes (4)

• Incidence and severity of procedural complications

  Up to 14 days

• Willingness for repeat sample collection

  Day 1

• Tolerability of dISF collection and other sampling techniques

  Day 1

• Tolerability of a single and two consecutive dISF sample collection in a single day

  Day 1

Study Arms (2)

Healthy Volunteers

Microneedle device samples will be collected as defined in the protocol as a non-invasive method.

Device: Microneedle Device

Participants with Atopic Dermatitis (AD)

Microneedle device samples will be collected as defined in the protocol as a non-invasive method.

Device: Microneedle Device

Interventions

Microneedle Device DEVICE

Microneedle device will be used for collecting dermal interstitial skin fluid samples as defined by the protocol.

Healthy Volunteers; Participants with Atopic Dermatitis (AD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 5 healthy participants and approximately 10 to 15 participants with mild to severe AD will be enrolled.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Related Links

• A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis Participants

Biospecimen

Retention: SAMPLES WITH DNA

Collecting biospecimens (dermal interstitial skin fluid (dISF), blood, skin tape strip, and biopsy.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: June 27, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)