Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)

Last updated: April 12, 2023
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Hives (Urticaria)

Skin Infections/disorders

Skin Wounds

Treatment

IDP-124 Vehicle Lotion

IDP-124 Lotion

Clinical Study ID

NCT03002571
V01-124A-301
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 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

Key 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)

Study Design

Total Participants: 338
Treatment Group(s): 2
Primary Treatment: IDP-124 Vehicle Lotion
Phase: 3
Study Start date:
July 24, 2018
Estimated Completion Date:
April 14, 2020

Study 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

Connect with a study center

  • Valeant Site 01

    Fort Lauderdale, Florida 33305
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.