IDP-122 Lotion
DrugTopical lotion
Other names: HP 0.01%
NCT Number: NCT02514577
This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Valeant Site 11, Hot Springs, Arkansas, United States
This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Topical lotion
Other names: HP 0.01%
Topical lotion. No active ingredient.
Time frame: Week 8
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time frame: Weeks 2, 4, 6, and 12 (4-week follow-up)
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Bausch Health Americas, Inc.
Industry
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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