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Clinical Trial Details for Inflammatory Cells From Various Pathologies


Innovaderm Research Inc.
NCT ID: NCT02270411
Last Updated: August 6, 2018

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 non-therapeutic experiment is to develop a method to isolate inflammatory cells from skin biopsies as well as a method to evaluate the expression of genes in those cells that are involved in inflammation. It could eventually be used to better understand the following conditions: atopic dermatitis, acne rosacea and acne vulgaris. It can also be used to better understand how various medications work in patients with atopic dermatitis, acne rosacea and acne vulgaris.Up to 15 healthy volunteers, 15 subjects with atopic dermatitis, 15 subjects with acne rosacea and up to 15 subjects with acne vulgaris will be selected. For healthy volunteers and subjects with atopic dermatitis, a maximum of four (4) skin biopsies (2-4 mm) per subject will be taken.For subjects with acne rosacea and acne vulgaris, a maximum of two (2) skin biopsies (3 mm) per subject will be collected. Biopsies will be performed on either the trunk or the limbs, excluding the hands and the feet. The biopsies will be used to develop a method to isolate inflammatory cells from the skin. Various protocols will be tested to find the best method. No medication will be given to you for this experiment.

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 criteria for volunteers with atopic dermatitis, acne rosacea or
acne vulgaris

– Patient has a history of atopic dermatitis, acne rosacea or acne vulgaris for at least
6 months.

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 rosacea, atopic dermatitis or acne vulgaris or UVB (Ultraviolet B) phototherapy
on the areas to be biopsied within 4 weeks of biopsy day

– Patient has used oral, intravenous, intramuscular or intra-lesional or intra-articular
steroids, or immunosuppressive medication on the areas to be biopsied within 4 weeks
of biopsy day

– Patient has used topical medication, natural health products or medical devices to
treat rosacea, atopic dermatitis or acne vulgaris on the areas to be biopsied within 4
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