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35 docs tagged with "Severity"

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Acne Severity Endpoints for Clinical Trials

Automated inflammatory lesion counting, spatial density, an IGA-scale severity score and ALADIN for acne clinical trials, from standardised photographs of the face. CE-marked medical device.

Clinical evidence

Evidence behind automated acne scoring, covering the peer-reviewed ALADIN study against expert dermatologists, the validation of the inflammatory lesion detector, the DIQA image quality gate, the post-market clinical follow-up, and the foundational acne references.

Clinical evidence

Evidence behind automated SALT scoring for alopecia, covering the validation of the hair loss segmentation model, the DIQA image quality gate, conference presentations, and the foundational SALT references.

Clinical evidence

Peer-reviewed publications behind automated SCORAD and EASI scoring for atopic dermatitis, including the primary automated-SCORAD study and the foundational SCORAD and EASI references.

Clinical evidence

Peer-reviewed publication behind automated IHS4 scoring for hidradenitis suppurativa, covering the AIHS4 study, the DIQA image quality gate, and the foundational IHS4 and HiSCR references.

Clinical evidence

Peer-reviewed publications and production validation behind automated PASI scoring for psoriasis, covering the peer-reviewed validation study, the DIQA image quality gate, and per-component performance against expert inter-rater variability.

Clinical Trial Experience

Legit.Health AI scoring is deployed in Phase 2 and Phase 3 clinical trials with top-10 pharma companies across 130+ sites in 12+ countries, spanning psoriasis, acne, alopecia, and atopic dermatitis.

Clinical Trial Workflow and Data Integration

End-to-end clinical trial workflow for acne endpoints, covering protocol design, site setup, patient enrolment, facial image capture, automated lesion counting and ALADIN scoring, IGA success against baseline, data export, and EDC integration.

Clinical Trial Workflow and Data Integration

End-to-end clinical trial workflow for SALT endpoints, covering protocol design, site setup, patient enrolment, in-clinic scalp capture, automated SALT scoring, change from baseline and alerts, data export, and EDC integration.

Clinical Trial Workflow and Data Integration

End-to-end clinical trial workflow for atopic dermatitis severity endpoints, covering protocol design, patient enrolment, image capture, AI scoring, severity tracking, data export, and EDC integration.

Clinical Trial Workflow and Data Integration

End-to-end workflow for cutaneous lupus erythematosus severity endpoints, covering retrospective image analysis versus prospective CLASI reconstruction, protocol design, capture, scoring, review, longitudinal tracking, and EDC data export.

Clinical Trial Workflow and Data Integration

End-to-end clinical trial workflow for hidradenitis suppurativa severity endpoints, covering protocol design, site setup, patient enrolment, in-clinic image capture, automated IHS4 and HiSCR, and EDC data export.

Clinical Trial Workflow and Data Integration

End-to-end clinical trial workflow for PASI endpoints, covering protocol design, site setup, patient enrolment, image capture, AI scoring, PASI response milestones, data export, and EDC integration.

Cutaneous Lupus Erythematosus Severity Endpoints for Clinical Trials

Automated CLASI scoring for cutaneous lupus erythematosus clinical trials. AI quantification of the visual components of CLASI Activity and CLASI Damage across 13 anatomical regions, plus a continuous repigmentation measure, from smartphone images. CE-marked medical device.

Imaging Protocol

How atopic dermatitis images are captured for automated SCORAD and EASI scoring: the standard body-perspective and close-up set, DIQA quality control, patient preparation, and site standardisation.

Imaging Protocol

How psoriasis images are captured for automated PASI scoring: the standard body-perspective and close-up set, DIQA quality control, patient preparation, and site standardisation.

Imaging Protocol: Region Capture, Traceability, and Calibration

Image capture protocol for cutaneous lupus erythematosus clinical trials, covering the 13-region CLASI capture set, target lesions, the metadata required to assemble a CLASI score, DIQA quality control, colour and scale calibration for erythema, pigmentation and lesion area, and facial anonymization.

Known Limitations

Transparent documentation of what the AI acne severity scoring can and cannot do, including scope boundaries, the status of the clinical evidence, skin type representation, and how each limitation is managed.

Known Limitations

Transparent documentation of what the AI alopecia severity scoring can and cannot do, including segmentation challenges, validation status, and how each limitation is managed.

Known Limitations

Transparent documentation of what the automated SCORAD and EASI scoring can and cannot do, including the inherent constraints of photograph-based assessment and how each limitation is managed.

Known Limitations

Transparent documentation of what AI CLASI component scoring can and cannot do in cutaneous lupus erythematosus, covering the items not derived from an image, the scarring and alopecia boundaries, region traceability, skin phototype, and CLE-specific validation status.

Known Limitations

Transparent documentation of what the automated IHS4 scoring for hidradenitis suppurativa can and cannot do, including the constraints of photograph-based lesion counting and how each limitation is managed.

Known Limitations

Transparent documentation of what the AI psoriasis severity scoring can and cannot do, including the inherent constraints of photograph-based PASI assessment and how each limitation is managed.

Sample Outputs and Deliverables

What sponsors, CROs and investigators receive from a cutaneous lupus erythematosus assessment. A per-visit report with real device outputs, the repigmentation signal CLASI-D cannot express, segmentation overlays, and structured EDC export fields.

Scoring Methodology: CLASI and CLA-IGA-R for Cutaneous Lupus Erythematosus

Item-by-item technical detail on how the device quantifies the CLASI Activity and CLASI Damage components, the 13-region structure, scale alignment between sign models and CLASI item scales, how per-image values aggregate into a CLASI score, and how the CLA-IGA-R is supported by capturing the investigator's grade and by estimating items from automatically measured visible signs.

Scoring Methodology: How the AI Calculates PASI

Technical detail on the automated PASI pipeline, covering affected-area segmentation, intensity scoring of erythema, desquamation and induration, the PASI formula, the severity scale, and comparison with manual scoring.

Scoring Methodology: SALT for Alopecia

Technical detail on how pixel-level hair loss segmentation produces the SALT score for alopecia, covering the four scalp quadrants and their weights, the SALT formula, severity bands, responder definitions against baseline, a worked example, and comparison with manual assessment.