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

Bausch Health

Status and phase

Completed

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: IDP-124 Lotion

Drug: IDP-124 Vehicle Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT03058783

V01-124A-302

Details and patient eligibility

About

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

Full description

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

Enrollment

328 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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