NCT02270411Completed
Inflammatory Cells From Various Pathologies
Development of a Method to Isolate Inflammatory Cells From Skin Biopsies of Patients With Various Pathologies for Quantitative Flow Cytometry Analysis
Source: ClinicalTrials.gov · Last updated 19 Jan 2024
Brief summary (registry, in English)
The objective of this experiment is to develop and validate in vitro methods to isolate inflammatory cells from skin biopsies for quantitative flow cytometry analysis. Real-time polymerase chain reaction (RT-PCR) will also be performed using skin biopsy samples to validate flow cytometry results. Such methods could eventually be used to better understand the pathophysiology and the mechanism of action of various medications in patients with atopic dermatitis, acne rosacea or vulgaris, HS, and systemic sclerosis. In this study, up to 15 healthy volunteers, 50 patients with atopic dermatitis, 15 patients with acne rosacea, 15 patients with psoriasis (to be used as control), 15 patients with acne vulgaris, 10 patients with psoriasis to develop a method of analysis for systemic sclerosis, and 10 patients with HS will be recruited. For the healthy volunteers, atopic dermatitis, psoriasis and HS groups, at least one (1) and a maximum of four (4) skin biopsies (4-5 mm) per subject will be performed. Biopsies will be performed on either the trunk or the limbs, excluding the hands and the feet. At least one (1) and a maximum of three (3) skin biopsies (2-3 mm) per subject will be collected for the acne rosacea and acne vulgaris groups from one or more body location(s) affected by the pathology. For patients with atopic dermatitis, an optional blood draw of up to 10 mL will be collected to measure serum IgE levels. For patients with atopic dermatitis, psoriasis, and HS, an optional blood collection of up to 50 mL will be collected to perform flow cytometry on circulating blood cells to study differences in flow cytometry results between cells extracted from biopsies and circulating cells.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 95 (actual)
- First submitted
- 17 Oct 2014
- Start date
- May 2014
- Primary completion date
- Dec 2023
- Lead sponsor
- Innovaderm Research Inc.
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT02270411
What you commit to
- Study type: Observational
- Participants enrolled: 95
- From May 2014 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject is currently participating in a clinical trial with an experimental drug or device
- Patient has used systemic medication, medical devices or natural health products to treat acne rosacea, atopic dermatitis, acne vulgaris, psoriasis, or HS, or UVB phototherapy within 4 weeks of biopsy day
- Patient has used oral, intravenous, intramuscular or intra-lesional or intra-articular steroids, or immunosuppressive medication within 4 weeks of biopsy day
- Patient has used topical medication, natural health products or medical devices to treat acne rosacea, atopic dermatitis, acne vulgaris, psoriasis, or HS on the areas to be biopsied within 2 weeks of biopsy day
- Patients is currently using or has used isotretinoin
Other illness
- Subject is known to have hepatitis B or hepatitis C viral infection
- Subject has a known hypersensitivity/allergy to lidocaine
- Patient has a history of keloids
Other
- Female subject is pregnant or lactating
- Subject is known to have immune deficiency or is immunocompromised
- Patient is taking heparin, warfarin or has a contraindication to skin biopsies.
- Patient has used a biologic agent within 24 weeks or 5 half-lives (whichever is longer) of biopsy day
Who the study is looking for
- Subject, male or female, is aged 18 years or older at the screening visit.
- Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening visit.
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- \*\*Special inclusion criterion for volunteers with atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS
- Patient has a history of atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS for at least 6 months.
- \*\*Special inclusion criterion for volunteers with atopic dermatitis
- Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Innovaderm Research Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.