AI-Powered Endpoint Scoring for Dermatology Clinical Trials

Objective, reproducible dermatological endpoint scoring, from smartphone images, in under 2 seconds.

Acne (IGA)
Psoriasis (PASI)
Alopecia (SALT)

Psoriasis Area and Severity Index

APASI Score: 13.6

Report Information

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Timestamp

3/24/2026, 2:16:00 AM

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Analysis performed in

1.8 seconds

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Status

Not reviewed

Body region	Weight	Erythema	Desquamation	Induration	BSA %	Area score	Region PASI
Head	0.1	2	2	1	30%	2	1.0
Trunk	0.3	3	2	2	15%	2	4.2
Upper extremities	0.2	2	1	2	10%	1	2.0
Lower extremities	0.4	3	3	2	20%	2	6.4

PASI = 1.0 + 4.2 + 2.0 + 6.4 = 13.6

Legit.Health provides automated scoring of dermatological endpoints for clinical trials. The AI quantifies severity using established clinical scales (IGA for acne, PASI for psoriasis, SCORAD for atopic dermatitis, and more), eliminating inter-rater variability and reducing site burden.

The technology is embedded in a CE-marked Class IIa medical device (MDD 93/42/EEC), built on an ISO 13485-certified quality management system and compliant with 21 CFR Part 11 for electronic records.

Proven in clinical trials

130+Investigator sites

12+Countries

Phase 2 & 3Trial phases

4–8 weeksTo deployment

The technology is actively deployed in clinical trials with top-10 pharma companies. Active engagements span psoriasis, acne, alopecia, atopic dermatitis, and generalized pustular psoriasis, including fully decentralised (home-based) capture validated in a pivotal Phase 3 programme.

AI-computed endpoints have been accepted by regulators as secondary endpoints and as a means to detect adverse events in clinical submissions.

See our clinical trial experience →

The problem with manual scoring

✗

Manual scoring

Same patient, same image — three dermatologists, three different scores:

Dermatologist A

IGA 2(Mild)

Dermatologist B

IGA 3(Moderate)

Dermatologist C

IGA 1(Almost clear)

Typical inter-rater agreement: Cohen's κ = 0.41–0.60

✓

AI scoring

Same patient, same image — always the same result:

Site 1, Visit 1

IGA 2(Mild)

Site 2, Visit 1

IGA 2(Mild)

Site 1, re-scored

IGA 2(Mild)

Intra-rater variability: 0.00 — perfectly reproducible

⇅

Inter-rater variability

Different investigators assign different scores to the same patient

⏱

Slow and costly

Lesion counting takes 5\u201315 minutes per patient and is impractical at scale

📊

Inflated sample sizes

Scoring noise masks treatment effects, requiring larger enrolments

🎓

Site training burden

Calibration exercises are costly, time-consuming, and imperfect

Manual scoring

AI scoring

5–15 min

Time per patient

< 2 sec

Significant

Inter-rater variability

Zero

Requires calibration

Multi-site consistency

Inherent

Limited by raters

Scalability

Unlimited

Per-patient fees

Cost model

Fixed per study

What we provide

Legit.Health delivers three core capabilities for dermatology clinical trials:

Capability	What it measures	Output
Automated lesion detection	Individual lesions via object detection, with per-lesion classification	Per-perspective and total integer counts
Spatial analysis	Lesion clustering, affected body surface area, and regional distribution	Density ratio or BSA percentage
Severity scoring	Global severity aligned with established clinical scales (e.g., IGA, PASI, SALT)	Score on the reference scale

These three capabilities form the foundation for all condition-specific endpoints. The specific outputs are tailored to each indication (lesion counts and IGA for acne, component scores and PASI for psoriasis, BSA and SALT for alopecia), but the underlying architecture is consistent.

How it works

The clinical trial workflow follows three steps:

1. Image capture at the investigator site

Investigators capture standardized photographs using the Legit.Health mobile application on a standard smartphone. The application guides the capture process with condition-specific perspective protocols and validates image quality in real time using the DIQA algorithm.

The number and type of perspectives vary by indication (2 facial perspectives for acne, 11 full-body perspectives for psoriasis, 4 scalp quadrants for alopecia), but the capture experience is consistent across all conditions.

2. Automated AI scoring

Uploaded images are processed by condition-specific deep learning models. Processing takes under 2 seconds. The system outputs:

Lesion detection or segmentation with visual overlays
Per-region and global severity scores aligned with the reference clinical scale
Image quality assessment (DIQA score)

Acne report
Psoriasis report
Alopecia report

Psoriasis Area and Severity Index

APASI Score: 13.6

Report Information

☐

Timestamp

3/24/2026, 2:16:00 AM

☐

Analysis performed in

1.8 seconds

☐

Status

Not reviewed

Body region	Weight	Erythema	Desquamation	Induration	BSA %	Area score	Region PASI
Head	0.1	2	2	1	30%	2	1.0
Trunk	0.3	3	2	2	15%	2	4.2
Upper extremities	0.2	2	1	2	10%	1	2.0
Lower extremities	0.4	3	3	2	20%	2	6.4

PASI = 1.0 + 4.2 + 2.0 + 6.4 = 13.6

3. Scored endpoints for data export

Results are available through the Legit.Health clinical trials platform and can be exported to EDC systems. Each report includes timestamped severity scores, per-perspective analyses, quality metrics, and longitudinal severity evolution.

Why sponsors choose this

No special hardware

Standard smartphone cameras replace expensive specialised photography equipment. This is a fraction of the cost of systems like Canfield VISIA, with no per-site rental fees and no hardware logistics.

Eliminates inter-rater variability

The AI produces the same score for the same image, every time, at every site, without calibration exercises. This reduces noise in endpoint data and can reduce required sample sizes.

Regulatory-aligned endpoints

The system provides the standard clinical scales that regulators expect (IGA for acne, PASI for psoriasis, SALT for alopecia) with the added benefit of perfect reproducibility. Novel composite scores (e.g., ALADIN for acne, APASI for psoriasis) are positioned for exploratory and secondary use, adding resolution for Phase 2 dose-finding and internal go/no-go decisions.

Regulatory endpoint acceptance

AI-computed endpoints from Legit.Health have been accepted as secondary endpoints and for adverse event detection in regulatory submissions. For primary registration endpoints, the system provides the standard clinical scales that regulators expect, with the added benefit of perfect reproducibility.

Under 2 seconds

Real-time scoring at the investigator site. No images sent to a central reader. No delays waiting for scores.

Multi-site consistency

Scores are comparable across all investigator sites without calibration exercises, training sessions, or inter-rater reliability assessments. The AI is the rater, and it is perfectly consistent.

QuantifiCare partnership

Seamless integration with QuantifiCare's standardised photography platforms and clinical trial services. The combined offering provides high-quality standardised photography with AI-powered endpoint scoring, a best-of-breed solution for sponsors who require both.

Indications

→

Acne

Automated lesion counting, spatial density, and IGA scoring. 2-perspective facial imaging with configurable protocols.

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Psoriasis

APASI scoring with 11-perspective full-body imaging. PASI 0–72 scale. Erythema, desquamation, induration, and BSA across 4 regions.

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Atopic Dermatitis

ASCORAD scoring. SCORAD 0–103 scale. Coming soon.

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Alopecia Areata

ASALT scoring with 4-quadrant scalp imaging. SALT 0–100 scale. Automated severity assessment and adverse event monitoring.

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Hidradenitis Suppurativa

AIHS4 scoring. IHS4 scale. Coming soon.

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Additional Indications

Vitiligo (VASI), Urticaria (UAS7), Wounds (AWOSI), Melasma (MASI), and more. Coming soon.

Learn more

Regulatory status

CE MarkClass IIaMDD 93/42/EEC

21 CFR Part 11CompliantElectronic records

ISO 13485CertifiedQuality management

ISO 27001CompliantInformation security

Software lifecycle per IEC 62304, usability per IEC 62366-1, risk management per ISO 14971, clinical evaluation per MEDDEV 2.7/1 Rev 4 and MDR Annex XIV.

Get started

AI-powered dermatology validated by peer-reviewed research. Trusted by leading hospitals across Europe. Fill in the form to see how our CE-marked platform can transform your practice.

Proven in clinical trials​

The problem with manual scoring​

Manual scoring

AI scoring

Inter-rater variability

Slow and costly

Inflated sample sizes

Site training burden

What we provide​

How it works​

1. Image capture at the investigator site​

2. Automated AI scoring​

3. Scored endpoints for data export​

Why sponsors choose this​

No special hardware​

Eliminates inter-rater variability​

Regulatory-aligned endpoints​

Regulatory endpoint acceptance​

Under 2 seconds​

Multi-site consistency​

QuantifiCare partnership​

Indications​

Acne

Psoriasis

Atopic Dermatitis

Alopecia Areata

Hidradenitis Suppurativa

Additional Indications

Learn more​

Clinical Trial Experience

Compliance & Data Security

Performance Across Skin Types

Regulatory status​

Get started

Proven in clinical trials

The problem with manual scoring

What we provide

How it works

1. Image capture at the investigator site

2. Automated AI scoring

3. Scored endpoints for data export

Why sponsors choose this

No special hardware

Eliminates inter-rater variability

Regulatory-aligned endpoints

Regulatory endpoint acceptance

Under 2 seconds

Multi-site consistency

QuantifiCare partnership

Indications

Learn more

Regulatory status