Inflammatory Cells From Various Pathologies

NCT02270411 | Completed

• 1 other identifier: Inno-6036
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atopic Dermatitis; Acne Rosacea; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Proportion of Inflammatory Cells in Skin Biopsies

  The proportion of inflammatory cells in skin biopsies will be assessed by flow cytometry.

  1 Day

Secondary Outcomes (1)

• Expression of Inflammation-Related Genes in Skin Biopsies

  1 Day

Study Arms (6)

Healthy Subjects

Healthy subjects.

Atopic Dermatitis

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.

Acne Rosacea

Patient has a history of acne rosacea for at least 6 months.

Acne Vulgaris

Patient has a history of acne vulgaris for at least 6 months.

Psoriasis

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invitation to volunteer

You may qualify if:

• 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.
• Patient has a history of atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS for at least 6 months.
• Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Rosacea; Acne Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Acneiform Eruptions; Sebaceous Gland Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)