Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis

Official Title
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Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: roflumilast cream 0.3%
* Drug: Zoryve
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed IRB approved written informed consent/assent 12 to 75 years of age, inclusive. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis. Baseline Investigator's Global Assessment Score of 3 (moderate). Subjects must have a Body Surface Area (BSA) between 2% to 20% Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study. Exclusion Criteria: Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. Current diagnosis of unstable forms of psoriasis in the treatment area. History of unresponsiveness to topical treatment for psoriasis Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Padagis active product<br> | Drug: roflumilast cream 0.3%<br>* test product<br>|
| Active Comparator: Reference product<br> | Drug: Zoryve<br>* RLD product<br>|
| Placebo Comparator: Padagis placebo product<br> | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) | percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1 | Day 1 to Day 56 |