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

Study to Assess the Reliability of Psoriasis Area Severity Index Scoring Using Digital-Based Images Compared to In-Person Evaluation

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Other: In-Person and Remote Disease Assessment

Detailed Description

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 (Actual): 34

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects with at least 0.5% their total BSA affected by plaque psoriasis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: ≥0.5 to <5% BSA affected; Approximately 10 subjects with psoriatic plaques covering at least 0.5% but less than 5% of their body surface area	Other: In-Person and Remote Disease Assessment; 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.
Cohort 2: ≥5 to <10% BSA affected; Approximately 10 subjects with psoriatic plaques covering at least 5% but less than 10% of their body surface area	Other: In-Person and Remote Disease Assessment; 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.
Cohort 3: ≥10% BSA affected; Approximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area	Other: In-Person and Remote Disease Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass Correlation Coefficient (ICC) between Physician's Global Assessment (PGA) assessed in-person and using digital photographs, all cohorts combined and by cohort.	The PGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity.	Day 1
Intraclass Correlation Coefficient (ICC) between Body Surface Area (BSA) assessed in-person and using digital photographs, all cohorts combined and by cohort.	The %BSA affected by psoriasis will be evaluated from 1 to 100%.	Day 1
Intraclass Correlation Coefficient (ICC) between PASI assessed in-person and using digital photographs, by cohort.		Day 1
Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by the same assessor.	This outcome measure will assess the variation in PASI scores when evaluated multiple times by the same assessor using digital photographs (intra-rater variability).	Day 1
Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by 2 assessors.	This outcome measure will assess agreement between assessors using digital photographs (inter-rater variability).	Day 1

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Investigators: Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): July 9, 2024
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: psoriasis; remote assessment; digital photographs
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: INNO-5033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No