Development of a Method to Measure mRNA Levels in Skin Samples

September 2, 2020 updated by: Innovaderm Research Inc.

Development of a Method to Measure mRNA Levels From the Skin of Patients With Psoriasis and Patients With Atopic Dermatitis Using Tape Strippings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 2V1
        • Innovaderm Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of skin biomarkers
Time Frame: Day 0
Gene expression of epidermal cytokines and chemokines.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovaderm Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2017

Primary Completion (Actual)

May 22, 2019

Study Completion (Actual)

October 2, 2019

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inno-5001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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