Psoriasis Clinical Trial
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Summary
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).
Full Description
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).
Eligibility Criteria
Key Inclusion Criteria:
Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).
Key Exclusion Criteria:
Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
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There are 15 Locations for this study
Hot Springs Arkansas, 71901, United States
Encinitas California, 92023, United States
Encino California, 91436, United States
Santa Rosa California, 95401, United States
Atlanta Georgia, 30301, United States
Boise Idaho, 83701, United States
Rockville Maryland, 20847, United States
Ann Arbor Michigan, 48103, United States
Clarkston Michigan, 48346, United States
Las Vegas Nevada, 89101, United States
Raleigh North Carolina, 27601, United States
Knoxville Tennessee, 37901, United States
Austin Texas, 73301, United States
San Antonio Texas, 78201, United States
Spokane Washington, 99201, United States
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