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

Clinical Trial ID: NCT03058783

Description

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


Criteria

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

  • Start Date

    2018-08-14

  • Last Updated

    2019-04-24

  • Sponsor

    Valeant Pharmaceuticals International, Inc.

  • Condition Name

    Atopic Dermatitis

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