Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Microneedle device samples will be collected as defined in the protocol as a non-invasive method. |
| |
| Participants with Atopic Dermatitis (AD) | Microneedle device samples will be collected as defined in the protocol as a non-invasive method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle Device | Device | Microneedle device will be used for collecting dermal interstitial skin fluid samples as defined by the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of dISF collected from normal skin in healthy participants and lesional skin from AD patients | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of procedural complications | Defined using the Investigator Global Assessment Scale. | Up to 14 days |
| Willingness for repeat sample collection | Defined using a 5- point likert scale questionnaire. |
Not provided
Inclusion Criteria:
All Participants:
Healthy Participants:
Participants with AD:
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.
Exclusion Criteria:
All Participants:
Healthy Participants:
Participants with AD:
Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
Not provided
Not provided
Approximately 5 healthy participants and approximately 10 to 15 participants with mild to severe AD will be enrolled.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
Not provided
| Label | URL |
|---|---|
| A Study to Evaluate Microneedle-based Collection of Dermal Interstitial Skin Fluid in Healthy Participants and Atopic Dermatitis Participants | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Collecting biospecimens (dermal interstitial skin fluid (dISF), blood, skin tape strip, and biopsy.
| Day 1 |
| Tolerability of dISF collection and other sampling techniques | Defined using the Local Skin Tolerability Scale. | Day 1 |
| Tolerability of a single and two consecutive dISF sample collection in a single day | Defined using the Local Skin Tolerability Scale. | Day 1 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |