Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
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.