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Clinical Trial Details for Inflammatory Cells From Various Pathologies


Innovaderm Research Inc.
NCT ID: NCT02270411
Last Updated: August 26, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 18 Years - N/A
  • Condition:
    • Atopic Dermatitis
    • Acne Rosacea
    • Acne Vulgaris
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: Innovaderm Research Inc.
  • Location: Not Provided

Official Title

Development of a Method to Isolate Inflammatory Cells From Skin Biopsies of Patients With Various Pathologies for Quantitative Flow Cytometry Analysis

Purpose

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.

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Population

Invitation to volunteer

Criteria

Inclusion Criteria:

– 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

Exclusion Criteria:

– Female subject is pregnant or lactating

– Subject is currently participating in a clinical trial with an experimental drug or
device

– Subject is known to have hepatitis B or hepatitis C viral infection

– Subject is known to have immune deficiency or is immunocompromised

– Subject has a known hypersensitivity/allergy to lidocaine

– Patient has a history of keloids

– Patient is taking heparin, warfarin or has a contraindication to skin biopsies.

– 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 a biologic agent within 24 weeks or 5 half-lives (whichever is
longer) 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

Additional Information, Locations & Contacts

Sponsors & Collaborators

Innovaderm Research Inc.

Investigators

Principal Investigator: Robert Bissonnette, MD

Innovaderm Research

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270411

Location

Contacts

Innovaderm Research

Montreal, Quebec H2K 4L5

Canada

MARIE-JOSEE MENARD

mjmenard@innovaderm.ca