Instrument template · Atopic dermatitisUpdated September 28, 2026

EASI eCRF template for atopic dermatitis trials

Sixteen severity ratings and four area scores, weighted by body region, give a total from 0 to 72. EASI-75, a 75% improvement from baseline, is a standard co-primary endpoint in atopic dermatitis trials. Capture every component so the total can be recalculated and checked.

  • 4 regions × 4 signs
  • Age-based region weights
  • Components kept for recalculation

Free sandbox · No credit card · 21 CFR Part 11 aligned

EASI · Week 16 · Trunk
Subject 017-0024 · Adult weightingDraft

Area involved

EASITRA
3 · 30 to 49%

Erythema

EASITRE
0123

Oedema / papulation

EASITRP
0123

Excoriation

EASITRX
0123

Lichenification

EASITRL
0123
Half-steps allowed where your protocol permits

At a glance

  • The EASI assesses four body regions: head and neck, upper limbs, trunk, and lower limbs.
  • In each region, four signs (erythema, oedema or papulation, excoriation, lichenification) are rated 0 to 3, and the area involved is scored 0 to 6.
  • Each region's score is (sum of signs) × area score × a region weight: 0.1, 0.2, 0.3 and 0.4 for adults and children 8 and over; 0.2, 0.2, 0.3 and 0.3 for children under 8.
  • The total runs from 0 to 72. EASI-75 (75% improvement from baseline) and EASI-90 are common endpoints.
  • The EASI is recommended by the Harmonising Outcome Measures for Eczema (HOME) initiative as the core measure of clinical signs.

In trials

Capture the components, not just the total

EASI is a calculation on 20 recorded values. If the eCRF stores only the total, nobody can check it, and a single arithmetic slip at a site can change a participant's responder status. Store the four area scores and sixteen sign ratings as separate coded fields, then derive region scores and the total in analysis, where the formula is written once and applied consistently.

Atopic dermatitis trials almost always pair EASI with the validated Investigator Global Assessment for atopic dermatitis (vIGA-AD, 0 to 4) as a co-primary endpoint, and with a peak pruritus NRS diary for itch. The DLQI is a common quality of life secondary.

Area scores

Area is scored 0 (none), 1 (1 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) or 6 (90 to 100%) of the region. A dropdown with the percentage bands as labels removes the need for assessors to remember the cut-offs.

EASI total · Subject 017-0024

Week 16

7.2 / 72

Moderate
0-1 Clear to almost clear1.1-7 Mild7.1-21 Moderate21.1-50 Severe50.1-72 Very severe
Baseline31.4
Week 812.6
Week 167.2
77% improvement: EASI-75 met

Calculation

EASI region weights

RegionWeight, age 8 and overWeight, under 8
Head and neck0.10.2
Upper limbs0.20.2
Trunk0.30.3
Lower limbs0.40.3

Region score = (erythema + oedema/papulation + excoriation + lichenification) × area score × weight. Total = sum of the four region scores. Severity band cut-offs vary between publications.

In Capture

Twenty coded fields with checks at entry

Each region is a section with an area dropdown and four sign ratings. Range checks stop out-of-scale values, every component exports as its own variable with labels, and source data verification can be switched on for the fields that drive the endpoint.

  • Area dropdown with percentage bands.
  • Range checks on every rating.
  • SDV per field on endpoint data.
EDC for dermatology trials
Vital signs · SDV configuration
SDV: 3 of 5 fieldsSDV config v3
  • Date of birth
  • Systolic blood pressure
  • Diastolic blood pressure
  • BMI (calculated)never verified
  • Position during measurement
  • Comments

Changed by Data manager · reason: critical safety value added

Build an EASI form with region sections

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Assessors

Training and consistency

EASI depends on the assessor's judgement of redness, thickness and extent, so inter-rater differences are real. Trials use trained assessors, keep the same assessor for a participant where possible, and schedule assessments at a consistent time relative to topical treatment and bathing. Photographs are sometimes taken for training or central review; if you collect them, handle them as identifiable data under your consent and privacy arrangements.

Record the assessor on the form and whether the child weighting applies. For participants who turn 8 during a long study, the protocol should state whether weights change with age or stay fixed from baseline, so the calculation is consistent.

Before go-live

EASI setup checklist

Components stored

Four area scores and sixteen sign ratings as separate fields.

Weights defined

Adult or child weighting, and the rule at age 8.

Half-steps decided

Whether 0.5 steps are allowed for signs.

Assessor training

Consistent assessors across visits.

Co-primary endpoint

vIGA-AD form alongside EASI.

Itch diary

Peak pruritus NRS if part of the endpoints.

FAQ

Questions about this template

Something not covered here? Ask us directly.

How is the EASI calculated?

For each of four regions, the sum of four sign ratings (0 to 3) is multiplied by the area score (0 to 6) and a region weight. The four region scores are added for a total of 0 to 72.

What is EASI-75?

An improvement of at least 75% from the baseline EASI total. It is a common co-primary endpoint in atopic dermatitis trials.

Are the weights different for children?

Yes. Children under 8 use 0.2, 0.2, 0.3 and 0.3 for head and neck, upper limbs, trunk and lower limbs; older participants use 0.1, 0.2, 0.3 and 0.4.

Should the eCRF store only the total?

No. Store every component so the total can be recalculated and checked.

Is the EASI free to use?

The EASI is widely used in research without a licence fee. Check the current guidance from its developers before use.

Does Capture calculate the EASI total?

Components are stored as coded values, and region scores and the total are derived from them in analysis.

EASI data you can recalculate

Every component coded and checked. Free sandbox.

Use the EASI template free