Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Detailed Description
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A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Official Title
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A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: IDP-118 Vehicle Lotion
* Drug: IDP-118 Vehicle Cream
* Drug: IDP-118 Lotion
* Drug: Ultravate Cream


Participation Criteria
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Eligibility Criteria
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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 BSA (Body Surface Area) 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 (Investigators 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.) If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization. Subject is willing to comply with study instructions and return to the clinic for required visits. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-118 Lotion<br>Lotion | Drug: IDP-118 Lotion<br>* Lotion<br>* Other names: Lotion;|
| Active Comparator: Ultravate Cream<br>Cream | Drug: Ultravate Cream<br>* Cream<br>* Other names: Ultravate;|
| Active Comparator: IDP-118 Vehicle Lotion<br>Lotion | Drug: IDP-118 Vehicle Lotion<br>* Vehicle<br>* Other names: Lotion;|
| Active Comparator: IDP-118 Vehicle Cream<br>Cream | Drug: IDP-118 Vehicle Cream<br>* Vehicle<br>* Other names: Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With Treatment Success | 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. 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). | 2 weeks |