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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1
Innovaderm Research
Montreal, Quebec, Canada, H2K 4L5