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

NCT05835843 | Completed

• 1 other identifier: INNO-5033
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Keywords

psoriasis; remote assessment; digital photographs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intraclass Correlation Coefficient (ICC) between Physician's Global Assessment (PGA) assessed in-person and using digital photographs, all cohorts combined and by cohort.

  Day 1

• Intraclass Correlation Coefficient (ICC) between Body Surface Area (BSA) assessed in-person and using digital photographs, all cohorts combined and by cohort.

  Day 1

• Intraclass Correlation Coefficient (ICC) between PASI assessed in-person and using digital photographs, by cohort.

  Day 1

Study Arms (3)

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

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

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

Interventions

In-Person and Remote Disease Assessment OTHER

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 1: ≥0.5 to <5% BSA affected; Cohort 2: ≥5 to <10% BSA affected; Cohort 3: ≥10% BSA affected

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male and female subjects aged 18 to 75 years, inclusive, at the time of consent.
• 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).
• Subject has plaque psoriasis covering at least 0.5% his/her total BSA at screening/Day 1 visit.
• Subject has a PGA score ≥2 at screening/Day 1 visit.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research

Montreal, Quebec, H2X 2V1, Canada

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: June 2, 2023
• Primary Completion: July 9, 2024
• Study Completion: September 5, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

CA (1)