Study to Assess the Reliability of PASI Scoring Using Digital-Based Images

Innovaderm Research Inc.34 enrolled

Overview

This is an open-labeled study to evaluate the reliability of digital photographs for the remote assessment of the disease severity of plaque psoriasis.

This study is being conducted to evaluate the reliability of digital photography for the remote assessment of psoriasis disease severity using the Psoriasis Area and Severity Index (PASI) compared to in-person evaluations. Approximately 30 adult subjects will undergo in-person assessments of the severity of the disease and have digital photographs taken for comparative remote evaluations.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Plaque Psoriasis

Interventions

In-Person and Remote Disease AssessmentOTHER

Disease severity will be assessed during the in-person visit and standardized digital photographs of different body regions and/or the full body will be collected for remote evaluations by external dermatologists.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female subjects aged 18 to 75 years, inclusive, at the time of consent. 2. Subject has at least a 6-month history of plaque psoriasis prior to screening visit (information obtained from medical chart or subject's physician, or directly from the subject). 3. Subject has plaque psoriasis covering at least 0.5% his/her total BSA at screening/Day 1 visit. 4. Subject has a PGA score ≥2 at screening/Day 1 visit. Exclusion Criteria: 1\. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.

Locations (1)

Innovaderm Research

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Intraclass Correlation Coefficient (ICC) between Psoriasis Area and Severity Index (PASI) assessed in-person and using digital photographs, all cohorts combined.

The PASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions, with adjustments for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body.

Time frame: Day 1

Data from ClinicalTrials.gov

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