Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

Study Overview
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Brief Summary
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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).

Detailed Description
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The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: IDP-122 Lotion
* Drug: IDP-122 Vehicle Lotion


Participation Criteria
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Eligibility Criteria
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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 in this assessment). 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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No

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-122 Lotion<br>Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks. | Drug: IDP-122 Lotion<br>* Medicated topical lotion<br>* Other names: HP 0.01%;|
| Placebo Comparator: IDP-122 Vehicle Lotion<br>Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks. | Drug: IDP-122 Vehicle Lotion<br>* Vehicle topical lotion with no active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Success at 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. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 | 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. | Weeks 2, 4, 6, and 12 (4-week follow-up) |