Efficacy and Safety of IDP-124 Lotion

• Status: Completed
• Trial end date: 2020-04-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.

Criteria

Key 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

Key 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)