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 ofconsent must sign an assent for the study and a parent or a legal guardian must signthe informed consent (if subject reaches age of consent during the study they shouldbe re-consented at the next study visit)
• Nonimmunocompromized male or female who failed to respond adequately to other topicalprescription treatment for AD or for whom those treatments are not advisable
• Subjects must be willing to comply with study instructions and return to the clinicfor required visits; subjects under the age of consent must be accompanied by theparent 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 thestudy 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, orichthyosis (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