Prior to participant enrollment, Institutional Review Board (USA) and local ethics committees in other countries reviewed and approved the study designs.
Efficacy assessments included severity Scoring of Atopic Dermatitis (SCORAD), patient-oriented SCORAD (PO-SCORAD), Sensiscale-10 questionnaire to evaluate skin sensitivity, the Dermatology Life Quality Index (DLQI), and digital photography. SCORAD evaluated the extent of eczema, the intensity of signs/symptoms on a scale of 0=absence to 3=severe, and subjective symptoms (pruritus and sleep) on a 0 to 10 visual analog scale. The 10-item Sensiscale-10 evaluation included inquiries on degree of overall skin irritation during the past 3 days and severity of skin conditions (tingling, burning, sensations of heat, tautness, itching, pain, general discomfort, hot flashes, and redness) during the past 3 days with a worst score of 100 and best score of 0.5. The 10-item DLQI is a health quality-of-life (QoL) scale specific to dermatologic disorders, with a scale of 0 to 30, and higher scores indicating more severe QoL impairment. Parents of children aged 4 to 14 years completed the PO-SCORAD and a Children's DLQI. Standard safety assessments were performed. Tolerability evaluations included erythema, edema, dryness/scaling, burning, itching, and stinging on scales of 0=none to 3=severe.
Study 2: Open-label Trial
This was an open-label, in-use study conducted in Europe (n=50) to evaluate the cutaneous and ocular tolerability, cosmetic acceptability, and performance of EFRC. To be eligible, patients had to be aged 18 to 60 years, could have any ethnic background and skin phototype, had eczema-prone skin with itchy, red, dry scaly skin (mild-to-moderate severity). Twenty participants had active lesions, and 30 had atopic-prone skin. All participants had sensitive skin (as defined by Sensiscale-10). It was conducted according to Good Clinical Practice and all patients completed a written informed consent form. The study was considered non-interventional and, as such, did not require approval by an ethics committee.
Statistical Analysis
For both studies, descriptive statistics were used in the statistical analysis of quantitative data by time point and zone. Categorical data were summarized in frequency and percentage points. T-test, Shapiro-Wilk test (a=0.01), and Wilcoxon signed rank tests were performed. For the subjective evaluation questionnaire, a dichotomic derived variable was used to divide participants into two categories: positive answer (1) or negative answer (0). The proportion of participants with a positive answer was compared to the theoretical value of 50% using a binomial test to assess whether a statistically significant majority of participants had a positive opinion. For all analyses, the type 1 error will be set at a=0.05 in two-tailed approach.
