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

Innovaderm Research

Status: Completed

Conditions: Plaque Psoriasis

Treatments: Other: In-Person and Remote Disease Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05835843

INNO-5033

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

34 participants in 3 patient groups

Cohort 1: ≥0.5 to <5% BSA affected

Description:

Approximately 10 subjects with psoriatic plaques covering at least 0.5% but less than 5% of their body surface area

Treatment:

Other: In-Person and Remote Disease Assessment

Cohort 2: ≥5 to <10% BSA affected

Description:

Approximately 10 subjects with psoriatic plaques covering at least 5% but less than 10% of their body surface area

Treatment:

Other: In-Person and Remote Disease Assessment

Cohort 3: ≥10% BSA affected

Description:

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

Treatment:

Other: In-Person and Remote Disease Assessment