NCT04537468

Development of a Method to Measure mRNA Levels in Skin Samples

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy
• Atopic Dermatitis Eczema
• Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-11
• Primary completion: 2019-05-22
• Completion: 2019-10-02
• First posted: 2020-09-03
• Last updated: 2020-09-04

Locations

1 site across 1 country: Canada