Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy
and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in
Pediatric and Adult Subjects

Inclusion Criteria:

- Male or female at least 2 years of age and older

- Written and verbal informed consent must be obtained; subjects less than age of
consent must sign an assent 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)

- Nonimmunocompromized male or female who failed to respond adequately to other topical
prescription treatment for AD or for whom those treatments are not advisable

- 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

Exclusion Criteria:

- Females who are pregnant, breast feeding, or who wish to become pregnant during the
study period

- Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg,
clinically infected AD)

- Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline,
which would interfere with evaluations

- History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or
ichthyosis (other than ichthyosis vulgaris)

- History or presence of:

- basal cell carcinoma of skin effectively treated more than 2 years ago

- carcinoma of cervix effectively treated more than 5 years ago

- immunological deficiencies or diseases, HIV, or serious recurrent infection

- clinically significant severe renal insufficiency or severe hepatic disorders

- Current or recent serious infection