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Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
roflumilast cream 0.3%
Zoryve
Placebo
Sponsored by
Padagis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DS Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Padagis active product

Reference product

Padagis placebo product

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
September 6, 2023
Sponsor
Padagis LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05763082
Brief Title
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Padagis LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Padagis active product
Arm Type
Experimental
Arm Title
Reference product
Arm Type
Active Comparator
Arm Title
Padagis placebo product
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
roflumilast cream 0.3%
Intervention Description
test product
Intervention Type
Drug
Intervention Name(s)
Zoryve
Intervention Description
RLD product
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA)
Description
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
Time Frame
Day 1 to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

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