Atopic dermatitis trials pair investigator scoring of skin with a daily itch diary on the participant's phone and a quality-of-life questionnaire. Capture puts the site forms and participant tasks in one study. Build and test free, no credit card.
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Diary days with data
88%
Participants under 80%
6
Week 16 visits due this month
9
Follow up with site
What an atopic dermatitis trial needs from its EDC
The study data
Phase 3 atopic dermatitis programmes have a recognisable endpoint pattern. The co-primary endpoints are usually the proportion of participants reaching an Investigator's Global Assessment of clear or almost clear (IGA 0 or 1) with at least a 2-point improvement, and the proportion reaching at least a 75% improvement in the Eczema Area and Severity Index (EASI-75), both assessed at a fixed week, commonly week 12 or 16. Key secondary endpoints typically include the proportion with a 4-point or greater improvement in peak pruritus on a numeric rating scale, the Dermatology Life Quality Index (DLQI), and often SCORAD or the Patient-Oriented Eczema Measure (POEM). Published analyses also note that IGA 0/1 can understate meaningful change, which is why EASI and itch are reported alongside.
Because the endpoints are responder definitions built on scores, the data needs to support the calculation without ambiguity. EASI is calculated from the extent and severity of signs across head and neck, upper limbs, trunk and lower limbs; the formula and region weights depend on age group. Capture's calculated fields show the derived score read-only, so the site enters the components and the system produces the total, which the statistician can verify against the dictionary. The EASI eCRF template shows a site-form structure for this, and the DLQI template shows the participant-reported form. SCORAD, which also combines an extent score, intensity score and subjective symptoms, can be built the same way from your licensed source.
The itch diary is where completeness is won. Peak pruritus is usually recorded daily on a 0 to 10 scale, with the weekly mean used in the analysis; a missing day weakens the mean. A phone diary opened from a secure link, with reminders by email or SMS and a daily completion window, protects it, and the compliance view by site shows where the team should intervene. See the numeric pain rating scale template for the 0 to 10 layout, adapted to an itch question you license or write. The dermatology-wide view is in EDC for dermatology clinical trials; this page goes specific to atopic dermatitis.
EASI and IGA are judgement scores, and a long study with several sites will have several investigators. Record the assessor on each form, keep the same assessor across visits where the protocol asks for it, and set an edit check on impossible combinations, for example area scored as 0 with a sign severity above 0. The audit trail shows every change with old value, new value, user and reason. Photography, where a protocol uses it, stays a source document; keep the filename or reference in the form so the record links to it.
EASI total
14.2 / 72
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Baseline EASI, IGA, BSA and itch thresholds, prior therapy | Eligibility screening template with edit checks |
| EASI | Region extent and sign scores, derived total | EASI eCRF template; calculated fields |
| IGA | Single severity grade, change from baseline | Site eCRF form with a derived responder flag |
| Peak pruritus | Daily 0 to 10 entry, weekly mean | Phone diary with reminders; NPRS layout |
| Quality of life | DLQI at baseline and key visits | DLQI eCRF template |
| SCORAD / POEM | Extent, intensity, symptom components | Site or participant form from your licensed source |
| Rescue and concomitant therapy | Topical steroid use, emollient, rescue dates | Concomitant medications template |
| Adverse events of interest | Conjunctivitis, injection-site reactions, skin infection | Adverse event form |
Item wording and scoring tables are yours to supply. Licensed instruments stay with your study documents; Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft visits and forms for you to review, and test with sample data. Free sandbox, no credit card.
Design details
Atopic dermatitis often starts in childhood, and programmes run adolescent and paediatric cohorts alongside adults. That changes the instruments (a child-friendly quality-of-life measure for younger participants, parent-reported items for the youngest) and the consent process: parent permission plus assent. Capture can set an assessment to be completed by a caregiver and offers a paediatric assent template to start from. Regions and weights for EASI differ by age group, so build one form per age band or a branching form with skip logic. See EDC for paediatric clinical trials.
Topical trials emphasise application adherence and local tolerability: applied-area records, local skin reactions and rescue use. Systemic and biologic trials emphasise laboratory safety, injection-related events and long-term extension. Both rely on the same forms with different emphasis. Rescue therapy rules are especially important, because the analysis often treats rescue use as a non-responder event, so define in the data management plan how rescue is recorded and when it triggers an intercurrent event.
Most programmes have a long-term extension after the placebo-controlled period, with visits at wider intervals to week 52 or beyond. Build the extension as an epoch with its own visit plan so the same participant record continues. Multi-site recruitment is normal; QR-code enrolment, site-level numbering and a site coordinator portal keep sites organised. See multi-site clinical trial management and Phase 3 EDC.
Build sequence
A practical order of work.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Typed fields per region and sign with calculated totals, assessor field and consistency checks.
A daily phone task with reminders and a completion window. Participants answer through a secure link, no app.
Visit windows around week 12 or 16 protect the primary analysis.
Run practice participants through all visits, including rescue use, and read the audit trail.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
EASI, SCORAD, DLQI and any itch scale used under their rights holders' terms, filed in the study documents.
Who scores EASI and IGA, and how continuity across visits is kept.
How rescue therapy is recorded and handled in the analysis.
Allowed range around week 12 or 16.
Minimum days per week for a valid weekly mean.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. The site enters region extent and sign scores as typed fields and a calculated field shows the derived total read-only. The formula and age-group weights come from your protocol and licensed source.
Yes. A 0 to 10 numeric rating question can be scheduled daily, opened from a secure link in the phone browser, with reminders and a completion window.
Yes. There are eCRF template pages for EASI and DLQI that show the form structure. Licensed instruments stay with your study documents; Capture does not supply instrument wording or verify licences.
Yes. Assessments can be set to be completed by a caregiver, and eConsent includes a paediatric assent template to start from.
Yes. Arms and epochs let the extension have its own visit plan under the same participant record.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports.
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