Plaque PsoriasisNCT05835843
Study to Assess the Reliability of PASI Scoring Using Digital-Based Images
An observational study of Plaque Psoriasis, run by Innovaderm Research Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- In-Person and Remote Disease Assessment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2023to 5 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female subjects with at least 0.5% their total BSA affected by plaque psoriasis.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess the Reliability of Psoriasis Area Severity Index Scoring Using Digital-Based Images Compared to In-Person Evaluation
This is an open-labeled study to evaluate the reliability of digital photographs for the remote assessment of the disease severity of plaque psoriasis.
Read the 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
- Being tested
- In-Person and Remote Disease Assessment
- Keywords
- psoriasis, remote assessment, digital photographs
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person and Remote Disease AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: In-Person and Remote Disease Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start2 Jun 2023
- Primary completion9 Jul 2024
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835843
- Sponsor's protocol ID
- INNO-5033
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Reliability of Psoriasis Area Severity Index Scoring Using Digital-Based Images Compared to In-Person Evaluation
- ClinicalTrials.gov ID
- NCT05835843
- Acronym / sponsor ID
- INNO-5033
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis, remote assessment, digital photographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ≥0.5 to <5% BSA affected | – | Other: In-Person and Remote Disease AssessmentApproximately 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 AssessmentApproximately 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 AssessmentApproximately 10 subjects with psoriatic plaques covering at least 10% of their body surface area |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects with at least 0.5% their total BSA affected by plaque psoriasis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person and Remote Disease AssessmentDisease 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. | Other | Cohort 1: ≥0.5 to <5% BSA affected, Cohort 2: ≥5 to <10% BSA affected, Cohort 3: ≥10% BSA affected |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Innovaderm Research Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.