ATOPIC DERMATITIS

(Valeant, 12 Weeks)

This is a multicenter, randomized, double-blind, parallel group, vehicle-controlled study to evaluate treatment success using a 5-point Investigator Global Assessment (IGA) scale from clear to severe; the improvement of Eczema Area Severity Index (EASI); improvement in total affected body surface area (TBSA); assessment of pruritus (itching) and sleep disturbance; Patient-Oriented Eczema Measure (POEM) from subjects and parents/legal guardians of pediatric subjects; and investigator’s assessment of signs and symptoms of AD.

The study consists of a 6-week double-blind treatment period and 4-week post-treatment follow-up. Study visits include Screening, Baseline, and Weeks 1, 2, 4, 6, and 10 (subjects will return to the clinic at Week 10 for a post-treatment follow-up visit).

1. Male or female at least 2 years of age and older.
2. Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent (as required per IRB/IEC guidelines) for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
3. Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable.
4. Clear diagnosis of AD fulfilling the diagnostic criteria of Hanifin and Rajka13 that affects ≥ 5% of TBSA (see Appendix 17.4 for full list of diagnostic criteria to reference); subject should have had a diagnosis of AD for at least 3 months; ie, determined by subject-reported or parent-reported duration of subject experiencing itchy and dry skin for 3 months or longer (at Screening and Baseline visits).
5. Subject must have a score of 3 (moderate) or 4 (severe) on the IGA scale at the Screening and Baseline visits.
6. Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.