Our study provides the first guide for interpreting the EASI score. It enables translation of the EASI numerical output into an AD global severity state that should be more meaningful to providers and patients. Along with a short administration time, the EASI demonstrates adequate feasibility, further supporting its use in clinical trials.
Background
Skin barrier dysfunction may precede infantile development of clinical atopic dermatitis (AD). Early‐life emollient therapy to enhance barrier function may prevent or modify AD development in high‐risk infants.
Objectives
(a) To determine whether daily full‐body application of an emollient with ceramide and amino acids (study emollient) can reduce the cumulative AD incidence compared to standard skin care at 1 year of age. (b) To evaluate the study emollient's effect on skin barrier function, natural moisturizing factor and the microbiome using non‐invasive biophysical and biochemical techniques.
Methods
We performed a single‐centre, investigator‐blinded, randomized controlled trial enrolling infants at high risk for AD development determined by family history. The intervention was full‐body once‐daily application of the study emollient. The control arm was asked to not apply full‐body emollient regularly and only use an emollient of their choice for dry skin. The primary outcome was the cumulative incidence of AD diagnosed at 12 months by a blinded investigator.
Results
Less than half the target sample size was enrolled (n = 100, goal sample was 208) with 28% lost to follow‐up. Across all clinical end points, a numerical trend was observed in favour of the intervention, although not statistically significant likely due to lack of power from under‐enrolment. AD was diagnosed in 13.2% vs. 25.0% at 12 months (P = 0.204) and 19.4% vs. 31.0% at 2 years (P = 0.296) in intervention vs. control groups, respectively. There were no significant differences between groups in skin barrier or microbiome assessments. While there were no serious adverse events, there were more cases of reported contact dermatitis in the intervention vs. control arms, 9.3% vs. 4.3%, respectively; however, these events were not related to the study emollient and most mild in severity.
Conclusion
The observed trends suggest a protective effect of daily study emollient therapy compared to control.
Atopic dermatitis is a common inflammatory skin disease. New understanding in
disease pathogenesis has led to a considerable number of promising new drugs in
development. New topical agents can be especially helpful for children,
providing an alternative to the need for chronic topical corticosteroid use.
While many patients with mild or moderate disease can be managed with topical
treatments, there are unmet needs for recalcitrant and severe cases. New and
developing therapies hold promise for real advances in management of this
complex disease.
Pyoderma gangrenosum (PG) is an inflammatory condition characterized by chronic cutaneous ulcerations. There are three proposed PG diagnostic frameworks (Su, PARACELSUS, Delphi); however, they lack consensus, and their performance has not yet been validated in a well-defined cohort of patients with PG. In this crosssectional retrospective cohort study, we sought to evaluate and compare the concordance of these diagnostic frameworks within a single-institution cohort of patients with PG. There were 47 patients from an initial 76 identified by International Classification of Diseases-9 and/or International Classification of Diseases-10 codes, where two PG experts agreed in their diagnosis of PG on the basis of clinical descriptions, photographs, and pathology. This group was the PG cohort by which we evaluated the performance and concordance of the diagnostic frameworks. The PARACELSUS score identified the highest proportion of patients with PG (89% [42 of 47 patients]), followed by Delphi and Su criteria, each at 74% (35 of 47 patients). Assessment of multirater agreement found that the three criteria agreed in their diagnoses for 72% of the patients (95% confidence interval ¼ 60e85%); chance-adjusted agreement was determined to be 0.44 (95% confidence ¼ 0.16e0.68, Fleiss' kappa). Future research should seek to refine these diagnostic frameworks and identify targeted methods of testing to reduce rates of PG misdiagnosis and patient misclassification in clinical trials.
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