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

NCT05835843 — Completed, 34 participants, Innovaderm Research Inc.

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

Registry	NCT05835843
Status	Completed
Study type	Observational
Enrollment	34 (Actual)
Sponsor	Innovaderm Research Inc. (Other)
Conditions	Plaque Psoriasis
Interventions	In-Person and Remote Disease Assessment (Other)
Dates	start 2023-06-02, primary completion 2024-07-09, completion 2025-09-05, first posted 2023-04-28, last updated 2025-09-12
Locations	1 site in Canada

-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.

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+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.

+Arms and interventions

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

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.

+Outcome measures

Primary outcomes

Intraclass Correlation Coefficient (ICC) between Psoriasis Area and Severity Index (PASI) assessed in-person and using digital photographs, all cohorts combined. [Day 1]: 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.

Other outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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)

Facility	City	Country	Status
Innovaderm Research	Montreal, Quebec	Canada

+Investigators

Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.