Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis

Overview

This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD \>16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc). SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.