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OpenTrials
Completed

NCT Number: NCT05763082

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

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

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Key information

Conditions

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DS Research

Louisville, Kentucky, 40241, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Roflumilast Cream 0.3%

Drug

test product

Zoryve

Drug

Reference Listed Drug product

Placebo

Drug

placebo

Primary outcomes

  1. Investigator's Global Assessment (IGA)

    Time frame: Day 1 to Day 56

    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

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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