Status:

COMPLETED

Inflammatory Cells From Various Pathologies

Lead Sponsor:

Innovaderm Research Inc.

Conditions:

Atopic Dermatitis

Acne Rosacea

Eligibility:

All Genders

18+ years

Brief Summary

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 react...

Detailed Description

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) ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2023

Estimated Enrollment :

95 Patients enrolled

Trial Details

Trial ID

NCT02270411

Start Date

May 1 2014

End Date

December 1 2023

Last Update

January 19 2024

Active Locations (1)

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Innovaderm Research

Montreal, Quebec, Canada, H2K 4L5