- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494396
An AI-Based Erythema Measurement System for Psoriasis Lesions
Development and Validation of an AI-Based Erythema Measurement System for Psoriasis Lesions Using Smartphone Imaging With Color Card Compared to Standard Color Calibration Device
Psoriasis is a common chronic inflammatory skin disease. Disease severity is commonly assessed using the Psoriasis Area and Severity Index (PASI), in which erythema is graded subjectively on a 0-4 scale. This visual assessment is prone to significant inter- and intra-rater variability.
Although objective tools such as colorimeters provide accurate erythema measurement, their high cost limits routine clinical use. Smartphone imaging combined with artificial intelligence (AI) offers a practical alternative for objective assessment. However, variability in lighting conditions can affect image consistency. Incorporating a color calibration card enables accurate color normalization.
This study aims to develop and validate an AI-based system for measuring erythema in psoriatic lesions using smartphone images with a color card, compared against a standard colorimeter to assess validity and reliability.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Suteeraporn Chaowattanapanit
- Phone Number: +66891879719
- Email: csuteeraporn@yahoo.com
Study Locations
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Changwat Khon Kaen
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Khon Kaen, Changwat Khon Kaen, Thailand, 40002
- Khon Kaen University
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Contact:
- Suteeraporn Chaowattanapanit
- Phone Number: +66891879719
- Email: csuteeraporn@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged ≥18 years
- Diagnosed with psoriasis by a dermatologist
- Presence of at least five clearly photographable lesions
- Willing and able to take photographs using a smartphone with both a standard color calibration card and a study-specific color card at home weekly, and submit images via Line or email
- Willing to have clinical photographs taken at baseline and at a follow-up visit
- Provides written informed consent to participate in the study
Exclusion Criteria:
- Presence of skin infection or other lesions that may interfere with color assessment (e.g., tattoos)
- Use of self-tanning products or substances that alter skin color
- Inability to perform photography or comply with study procedures
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To evaluate the accuracy of erythema measurements of psoriatic lesions obtained from an AI-based erythema model (smartphone imaging with a color calibration card) compared with a standard color calibration device (gold standard).
Time Frame: From enrollment to 12 weeks
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From enrollment to 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE694001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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