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

NCT ID: NCT05835843

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2025-09-05

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.

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.

Conditions

Plaque Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

In-Person and Remote Disease Assessment

Intervention Type: 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 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

In-Person and Remote Disease Assessment

Intervention Type: 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 3: ≥10% BSA affected

Approximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area

In-Person and Remote Disease Assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Locations

Innovaderm Research

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

INNO-5033

Identifier Type: -

Identifier Source: org_study_id