Psoriasis Clinical Trial
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Summary
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Full Description
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis
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) Investigator Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, 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 13 Locations for this study
Encino California, 91316, United States
Orange Park Florida, 32065, United States
Pinellas Park Florida, 33780, United States
Tampa Florida, 33601, United States
Tampa Florida, 33601, United States
Plainfield Indiana, 46168, United States
Clarkston Michigan, 48346, United States
Fridley Minnesota, 55421, United States
Saint Joseph Missouri, 64501, United States
Greenville South Carolina, 29601, United States
Murfreesboro Tennessee, 37129, United States
College Station Texas, 77840, United States
Webster Texas, 77598, United States
Charlottesville Virginia, 22901, United States
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