Inflammatory Cells From Various Pathologies
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|ClinicalTrials.gov Identifier: NCT02270411|
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : August 28, 2019
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.
|Condition or disease|
|Atopic Dermatitis Acne Rosacea Acne Vulgaris|
Innovaderm, in collaboration with "The Immunoregulation laboratories of CRCHUM" and "McGill University division of dermatology", recently developed a novel 6-hour method to study IL-17A (Interleukin) and IL-22 from fresh biopsies of psoriatic patients. This reproducible experimental approach combines enzymatic digestion and mechanical dissociation for skin cell isolation. This is followed by a multi-color flow cytometry analysis in the absence of in vitro expansion and re-stimulation. Using this method, we examined the cellular source of IL-17A and IL-22 on a small number (20x10³) of viable CD45+ (Cluster of Differentiation Antigen 45) cells that are freshly isolated from 4 mm punch skin biopsies (n=22 patients with psoriasis). The method was used for the study on "Persistence of IL-17A+ T lymphocytes and IL-17A expression in psoriatic plaques refractory to ustekinumab therapy" presented during the 72nd annual meeting of the American Academy of Dermatology in Denver. A detailed presentation of this method will be done during the upcoming annual meeting of the Society for Investigative Dermatology in Albuquerque, New Mexico.
We would like to investigate and adapt this method for other dermatological conditions such as Atopic Dermatitis, Acne Rosacea and Acne Vulgaris.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Development of a Method to Isolate Inflammatory Cells From Skin Biopsies of Patients With Various Pathologies for Quantitative Flow Cytometry Analysis|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patient has a history of atopic dermatitis for at least 6 months. Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria.
Patient has a history of acne rosacea for at least 6 months.
Patient has a history of acne vulgaris for at least 6 months.
Patient has a history of psoriasis for at least 6 months.
Hidradenitis Suppurativa (HS)
Patient has a history of HS for at least 6 months.
- Proportion of Inflammatory Cells in Skin Biopsies [ Time Frame: 1 Day ]The proportion of inflammatory cells in skin biopsies will be assessed by flow cytometry.
- Expression of Inflammation-Related Genes in Skin Biopsies [ Time Frame: 1 Day ]The level of expression of inflammation-related genes in skin biopsies will be assessed by quantitative real-time polymerase chain reaction (qRT-PCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270411
|Contact: Stéphanie Légaré||514-521-4285 ext firstname.lastname@example.org|
|Montreal, Quebec, Canada, H2K 4L5|
|Contact: MARIE-JOSEE MENARD 514-521-4285 ext 380 email@example.com|
|Principal Investigator: Robert Bissonnette, MD|
|Sub-Investigator: Catherine Maari, MD|
|Principal Investigator:||Robert Bissonnette, MD||Innovaderm Research|