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Development of a Method to Measure mRNA Levels in Skin Samples

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ClinicalTrials.gov Identifier: NCT04537468
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Innovaderm Research Inc.

Study Description
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Brief Summary:
The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Healthy Atopic Dermatitis Eczema Psoriasis Other: Skin squame collection Other: Tape strip collection Other: Tape strip and skin biopsy collection Not Applicable

Detailed Description:
Three sequential groups of subjects were recruited in this study for: 1) skin squame collection; 2) tape strip collection; and 3) tape strip and skin biopsy collection in the aim of identifying the most optimal method for measuring the mRNA levels of skin biomarkers in tape strip samples.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

The study consisted of 3 sequential groups:

  1. Collection of skin squames by scraping.
  2. Collection of tape strip samples.
  3. Collection of tape strip samples and skin biopsies.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Method to Measure mRNA Levels From the Skin of Patients With Psoriasis and Patients With Atopic Dermatitis Using Tape Strippings
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : May 22, 2019
Actual Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Skin sample collection
Skin sample collection for gene expression analyses.
 Other: Skin squame collection
Subjects underwent skin squame collection by scraping. The investigator gently scraped the surface of a lesional skin area for patients with psoriasis, and of a non-lesional skin area for healthy volunteers to collect superficial cells. These samples were analyzed by gene expression analyses.

Other: Tape strip collection
The first subjects had up to 35 tape strips from a maximum of 4 areas (4 X 35 strippings) on the trunk or limbs (excluding the genital area). Patients with atopic dermatitis or psoriasis had tape stripping performed on lesional skin areas and the control subjects had tape stripping performed on nonlesional skin areas. The next subjects were used to determine the optimal number of tape strips required to obtain a good signal by gene expression analyses.

Other: Tape strip and skin biopsy collection
Subjects had tape stripping on up to 3 different skin areas (2 areas on lesional skin and one area of nonlesional skin for patients with atopic dermatitis or psoriasis, and 2 areas of healthy skin for control subjects) using the optimal number of tape strips, as determined in the previous part. One 4-mm skin biopsy on a tape stripped area plus one 4-mm biopsy on non-tape-stripped skin (2 biopsies per subject) were also collected.


Outcome Measures
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Primary Outcome Measures :
  1. Expression of skin biomarkers [ Time Frame: Day 0 ]
    Gene expression of epidermal cytokines and chemokines.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject, male or female, aged 18 years or older at the time of consent.
  • Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.

  • Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.

    *Special inclusion criteria for volunteers with atopic dermatitis or psoriasis:

  • Patient had a history of atopic dermatitis or psoriasis.
  • Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day 0.
  • Patients with atopic dermatitis had an Investigator's Global Assessment (IGA) score of ≥2 at Day 0.

Exclusion Criteria:

  • Female subject was pregnant or breastfeeding.
  • Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
  • Subject was known to have hepatitis B or hepatitis C viral infection.
  • Subject was known to have immune deficiency or was immunocompromised.
  • Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
  • Subject had used oral, intravenous steroids, or immunosuppressive medication within 4 weeks of the collection day (Day 0). Subject had used intramuscular or intra-lesional or intra-articular steroids or immunosuppressive medication on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
  • Subject had used a biologic within 12 weeks or 5 half-lives of the collection day (Day 0), whichever was longer.

  • Subject had used topical medication, natural health products or medical devices to treat atopic dermatitis or psoriasis on the areas to be tape stripped or biopsied within 2 weeks of the collection day (Day 0).

    *Only for subjects who underwent skin biopsy:

  • Subject had a known hypersensitivity/allergy to lidocaine.
  • Subject had a history of hypertrophic scarring or keloid formation in scars or suture sites.
  • Subject was taking anti-coagulant medication (e.g. heparin, low molecular weight [LMW]-heparin, warfarin, anti-platelets [nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin (equal or lower than 81 mg) were not considered anti-platelets]) or had a contraindication to skin biopsies.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537468


Locations
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Canada, Quebec
Innovaderm Research, Inc.
Montreal, Quebec, Canada, H2X 2V1
Sponsors and Collaborators
Innovaderm Research Inc.
Investigators
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Principal Investigator: Robert Bissonnette, MD Innovaderm Research Inc.
More Information
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Publications of Results:

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Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT04537468    
Other Study ID Numbers: Inno-5001
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Innovaderm Research Inc.:
Skin squames
Tape stripping
Skin biopsy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Psoriasis
Dermatitis
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
 Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases