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
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
Connect with a study center
Valeant Site 01
Fort Lauderdale, Florida 33305
United StatesSite Not Available
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