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Completed

NCT Number: NCT05835843

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

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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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Innovaderm Research

Montreal, Quebec, H2X 2V1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: Day 1

    The %BSA affected by psoriasis will be evaluated from 1 to 100%.

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

    Time frame: Day 1

  4. Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by the same assessor.

    Time frame: 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).

  5. Intraclass Correlation Coefficient (ICC) of PASI scores assessed using digital photographs by 2 assessors.

    Time frame: Day 1

    This outcome measure will assess agreement between assessors using digital photographs (inter-rater variability).

Sponsors and collaborators

Lead sponsor

Innovaderm Research Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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