Precefi Insights  |  October 2026

Clearer skin is the result most atopic dermatitis trials are built to show. This Eczema Awareness Month, it is worth asking whether patients also feel the difference, in less itch, better sleep and disease that stays under control.

Key Takeaway

Skin improvement matters, and it remains central to atopic dermatitis trials. But it tells only part of the story. Adding sound measures of symptoms, quality of life and disease control gives sponsors a fuller picture of what a treatment does, as long as the endpoints are planned carefully and the data are collected consistently.

Skin Improvement Is One Part of Treatment Benefit

The Eczema Area and Severity Index (EASI) scores how much skin is affected by atopic dermatitis (AD) and how severe the visible signs are. It is a well-established way to measure severity and treatment response. What it does not measure directly is how much a patient itches, how well they sleep or how eczema affects their day.[1]

So for sponsors, the real question is whether better skin scores come with real relief in patients’ daily lives.

Itch Needs a Direct Patient Measure

Itch is subjective. You can’t tell how intense it is just by looking at a lesion. The Peak Pruritus Numerical Rating Scale (NRS) asks patients to rate their worst itch over the past 24 hours from 0 to 10. In validation work with adults who had moderate-to-severe AD, the scale proved reliable and picked up changes over time.[2]

The same study found that itch scores tracked other patient-reported itch measures more closely than they tracked clinician-assessed signs. That is a good reason to measure itch directly, alongside skin improvement.[2]

Sleep Deserves Its Own Assessment

Poor sleep in AD can mean trouble falling asleep, waking in the night or feeling the effects the next day. A 2024 study used patient interviews and clinical trial data to evaluate sleep measures in AD, and it supported a sleep disturbance NRS for use in adults with the disease.[3]

An itch score on its own may not tell sponsors much about sleep benefit. Whichever sleep measure a study uses should fit the question it is asking, whether that is overall sleep disturbance or sleep lost to itch, and should have support in the intended population. Those are different things, and one shouldn’t stand in for the other.[3]

Disease Control Requires More Than a Single Visit

AD flares and settles over time, so a single visit can miss a lot. Repeated assessments show whether patients stay in control. Recap of Atopic Eczema (RECAP) was developed with patients, caregivers and clinicians to capture how controlled eczema feels, reported by the patient or a caregiver.[4]

The Harmonising Outcome Measures for Eczema (HOME) initiative recommends that AD trials cover four areas: clinical signs, patient symptoms, quality of life and long-term control. Its recommended tools include EASI, the Patient-Oriented Eczema Measure (POEM) and RECAP, along with measures of itch and quality of life.[5]

Where they fit the study’s objectives, protocol-defined records of flares, rescue treatment or treatment burden can add to repeated control measures. Each needs a clear definition and an assessment schedule that makes the results interpretable.

Four Protocol Decisions That Strengthen Patient Outcome Data

  1. Match each measure to a specific question. Be clear about what the study needs to show and why each instrument is there. POEM, for example, asks how often patients had seven eczema symptoms over the past week, including itch and sleep disturbance. A weekly frequency measure and a daily intensity rating answer different questions.[6]
  2. Establish the analysis plan early. Decide each endpoint’s role, the assessment time points and how meaningful change for an individual patient will be judged. A statistically significant difference in the average doesn’t prove that individual patients benefited in a meaningful way. Settle how missing data will be handled before any results come in.[7]
  3. Make completion practical and consistent. Set completion windows that fit each instrument’s recall period. Train participants and site staff, use the right language and age versions, and keep an eye on how many questionnaires patients are asked to fill in. Instructions should help patients report accurately without steering their answers.[7]
  4. Monitor data collection between visits. Give sites a way to spot missed assessments and fix access or device problems quickly. For electronic diaries, agree on reminders, technical support and documentation before the study starts. Good technology helps, but it works best with responsive site support behind it.[7]

The Precefi Approach to Patient Outcome Data

Precefi brings dermatology-focused expertise and investigator networks in the United States and Latin America together under one contract and one price. Site planning covers participant training and questionnaire completion as well as clinical assessments.

Precefi’s proprietary Appiell platform supports electronic diaries, image capture, real-time data collection and participant reminders. It can support study-defined collection and monitoring of patient-reported data, working alongside the right outcome measures, a clear analysis plan and consistent site execution.[8]

A Fuller Account of Treatment Benefit

Eczema Awareness Month is a reminder of how much this disease affects daily life. When trials measure symptoms and long-term control along with clinical improvement, sponsors can show what a treatment actually changes for patients. That evidence depends on consistent data collection at every site.

To discuss how Precefi can support your next atopic dermatitis program, contact rich@precefi.com or visit precefi.com.

References

  1. Hanifin JM, Baghoomian W, Grinich E, Leshem YA, Jacobson M, Simpson EL. The Eczema Area and Severity Index—A Practical Guide. Dermatitis. 2022;33(3):187–192. doi:10.1097/DER.0000000000000895. Source
  2. Yosipovitch G, Reaney M, Mastey V, et al. Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019;181(4):761–769. doi:10.1111/bjd.17744. Source
  3. Dias-Barbosa C, Silverberg JI, Ständer S, et al. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024;8:73. doi:10.1186/s41687-024-00751-7. Source
  4. Howells LM, Chalmers JR, Gran S, et al. Development and initial testing of a new instrument to measure the experience of eczema control in adults and children: Recap of atopic eczema (RECAP). Br J Dermatol. 2020;183(3):524–536. doi:10.1111/bjd.18780. Source
  5. Williams HC, Schmitt J, Thomas KS, et al. The HOME Core outcome set for clinical trials of atopic dermatitis. J Allergy Clin Immunol. 2022;149(6):1899–1911. doi:10.1016/j.jaci.2022.03.017. Source
  6. University of Nottingham. Patient-Oriented Eczema Measure (POEM). Self-completion/caregiver-reported, English (UK). January 30, 2025. Accessed October 7, 2026. Source
  7. U.S. Food and Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Guidance for industry. December 2009. Accessed October 7, 2026. Source
  8. Precefi. Virtual Platform. Accessed October 7, 2026. Source