Precefi Insights  |  October 2026

October is Eczema Awareness Month, and it is a useful time for sponsors to check two things. Are our atopic dermatitis trials measuring disease the same way in every patient? And are they enrolling the patients who need new treatments most?

Key Takeaway

Most atopic dermatitis severity scores rely on judging inflammation, and inflammation looks different on darker skin. Sponsors who plan for this in the protocol, with rater training across skin tones, patient-reported endpoints and well-chosen sites, end up with evidence that better reflects the patients they enroll.

The Patients With the Heaviest Burden Need the Closest Look

Every October, Eczema Awareness Month draws attention to the more than 31 million Americans living with eczema.[1] Atopic dermatitis (AD) is a common form of eczema, and its burden is not spread evenly.

In the U.S., Black patients have higher rates of AD than White patients, and their disease tends to be more severe and to last longer. Some studies also find greater severity among Hispanic or Latino children with AD. The evidence there is thinner, though, and it shouldn’t be assumed to match the findings in Black patients. Environmental exposures and access to care are among the factors behind these differences.[2]

Race, ethnicity and skin tone are not the same thing. A trial has to think about which populations it enrolls and also about the range of skin tones within them.

Reading Inflammation on Darker Skin Takes Specific Training

The Eczema Area and Severity Index (EASI) scores four signs (erythema, edema or papulation, excoriation and lichenification) along with how much skin is affected. On darker skin, inflammation can look violet rather than red, or simply less red. Published scoring guidance lists underestimating inflammation in darker skin as a common mistake.[3]

The research on scoring reliability is mixed but encouraging. In a 2015 study, five clinicians scored full-body photographs of 18 patients and agreed poorly on patients with very dark skin. A later study scored 25 patients in person and found that EASI held up well across skin colors. Both studies were small and used different methods. Taken together, they suggest established scales like EASI can work across skin tones when raters are experienced and patients are assessed under the right conditions.[4,5]

A systematic review also found that studies of these outcome measures often did not report race or skin tone, or test whether the measures performed equally well across groups.[6]

What this means for sponsors: If scoring is inconsistent, it can change who qualifies at screening and how severity and treatment response are measured. Rater training and calibration should cover every presentation the study is likely to see.

Clinician Scores Don’t Capture Everything Patients Experience

AD doesn’t look the same on every skin tone, in the lesions themselves or in where they appear. On darker skin, long-standing eczema often shows up as darkened, dry or scaly patches with thickened, leathery skin. Raters need to recognize these signs and tell active eczema apart from pigment changes left behind after it clears.[3,7]

What patients feel goes beyond what a rater can see. Pigment changes can last after the eczema itself improves. Itch, poor sleep and the effect on daily life may not show up fully in a clinician’s severity score. That makes a case for pairing clinical assessments with suitable patient-reported outcomes and, where it fits the study, exploratory pigmentation assessments.[2,3,6,7]

Representation Gaps Persist in Hispanic Populations and Among Black Children

An analysis of 68 completed AD trials with results available from 2019 through May 2024 (20,679 participants) found that more Black and Asian participants are being included. Hispanic or Latino participants made up only 10.8% of enrollment. Trial locations and incomplete ethnicity reporting may account for some of that, but it is still a gap worth closing.[8]

Among children the gap is wider. A 2026 review of 21 trials of advanced systemic therapies found that Black participants made up just 9.4% of 3,148 patients. The barriers it named were practical ones: mistrust, language, limited awareness of trials and the logistics of taking part. Sites do much of the work of addressing them, with support from the sponsor and a protocol that makes participation realistic.[9]

Five Design Choices That Close the Gap

Sponsors don’t have to wait for a new scale. Each of the steps below can be built in at the protocol and site-selection stage.

  1. Train raters on the full range of skin tones. Use training and calibration material that covers the full range of skin tones, with clear guidance on how inflammation looks on darker skin. Keep reinforcing the protocol’s scoring criteria for the whole study, including after the first calibration.[3,5]
  2. Use standardized photography to support assessment. Set rules for lighting, positioning and image quality. Photos help with documentation and review, but some signs, such as edema or papulation, may need to be felt as well as seen, so assess them in person when needed.[3]
  3. Give the patient perspective real weight. Choose measures of itch, sleep, symptoms and quality of life to sit alongside clinical signs, for example an itch numerical rating scale, the Patient-Oriented Eczema Measure and an age-appropriate quality-of-life questionnaire. Use the right language versions, and check how well each measure performs in the population you are studying.[6]
  4. Measure pigmentation outcomes. If pigment changes matter for the population or the treatment goal, prespecify how they will be assessed. Pick methods with evidence behind them, label exploratory outcomes clearly, and keep leftover pigmentation separate from active disease when you analyze results.[3,7]
  5. Choose sites for the population, not just the volume. Look at the communities each site serves, its investigators’ experience, its language support and the practical help it offers participants. Build recruitment and retention plans around the study population and the barriers patients face locally.[9]

The Precefi Network: Built For The Patients AD Trials Miss

Precefi brings dermatology-focused expertise and investigator networks in the United States and Latin America together under one contract and one price. Between the two regions, sponsors can reach patients from a broad range of backgrounds and skin tones. Sites for each study are chosen to match its population goals, including the specific U.S. communities a sponsor needs to reach.

Precefi’s proprietary Appiell platform handles image capture, electronic diaries and real-time data collection, which helps keep assessment and monitoring consistent from site to site.[12]

Why Now

FDA issued draft guidance on Diversity Action Plans in June 2024, covering enrollment goals and strategies for underrepresented populations. As of October 5, 2026, FDA’s guidance page still lists it as a draft. According to FDA, the legal requirement to submit a plan applies to covered studies that begin enrolling more than 180 days after the final guidance is published.[10,11]

That leaves sponsors without a firm deadline, but waiting is risky. The requirement is still in the law. And population goals, assessment methods and site capabilities are much easier to line up while the protocol is being written than once recruitment has started.

Why Precefi

  • Dermatology-focused expertise: a site network built around dermatology, ophthalmology and aesthetics trials
  • U.S. and Latin America site network: access to the diverse patient populations Diversity Action Plans call for
  • Leading KOL network: scientific input on endpoint selection and rater training
  • Single contract model: one contract, one price across every site
  • Operational simplicity and execution excellence: consistent assessment and data quality from first patient in to database lock

Conclusion

Eczema Awareness Month is about helping people see eczema more clearly, and that applies to clinical research too. When assessment varies by skin tone, or trials miss the patients most affected, sponsors end up with noisier data, weaker subgroup evidence and tougher questions from regulators and payers.

The solutions already exist. They include rater training across all skin tones, patient-reported outcomes, pigmentation assessments where they matter, and sites that reach the right patients. Sponsors who plan for them from the start will run stronger AD trials, with evidence that better reflects the patients who need treatment.

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

References

  1. National Eczema Association. Eczema Awareness Month. Accessed October 5, 2026. Source
  2. Croce EA, Levy ML, Adamson AS. Reframing racial and ethnic disparities in atopic dermatitis in Black and Latinx populations. J Allergy Clin Immunol. 2021;148(5):1104–1111. doi:10.1016/j.jaci.2021.09.015. Source
  3. 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
  4. Zhao CY, Wijayanti A, Doria MC, et al. The reliability and validity of outcome measures for atopic dermatitis in patients with pigmented skin: A grey area. Int J Womens Dermatol. 2015;1(3):150–154. doi:10.1016/j.ijwd.2015.05.002. Source
  5. Zhao CY, Hao EY, Oh DD, et al. A comparison study of clinician-rated atopic dermatitis outcome measures for intermediate- to dark-skinned patients. Br J Dermatol. 2017;176(4):985–992. doi:10.1111/bjd.15271. Source
  6. Kaundinya T, Rakita U, Guraya A, et al. Differences in Psychometric Properties of Clinician- and Patient-Reported Outcome Measures for Atopic Dermatitis by Race and Skin Tone: A Systematic Review. J Invest Dermatol. 2022;142(2):364–381. doi:10.1016/j.jid.2021.06.033. Source
  7. Nguyen C, Thompson J, Nguyen DA, et al. Presentations of Cutaneous Disease in Various Skin Pigmentations: Chronic Atopic Dermatitis. HCA Healthc J Med. 2024;5(2):103–111. doi:10.36518/2689-0216.1644. Source
  8. Kabakova M, Wang JY, Patel P, Zafar K, Bitterman D, Jagdeo J. Racial and Ethnic Representation in Atopic Dermatitis Clinical Trials. J Drugs Dermatol. 2025;24(4):360. doi:10.36849/JDD.8705. Source
  9. Hamud R, Pratt ME. Advanced Systemic Therapies for Pediatric Atopic Dermatitis and Skin of Color: A Review and Strategies for Improving Trialist Involvement. J Cutan Med Surg. Published online June 22, 2026. doi:10.1177/12034754261458398. Source
  10. U.S. Food and Drug Administration. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. Draft guidance for industry. June 2024. Accessed October 5, 2026. Source
  11. U.S. Food and Drug Administration. Report to Congress: Diversity Action Plans Summary FY 2023 and FY 2024. Accessed October 5, 2026. Source
  12. Precefi. Virtual Platform. Accessed October 5, 2026. Source