Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

NCT05763082 | Completed Phase 3 FDA Drug

• 1 other identifier: PAD-NY-22-05
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Padagis active product

EXPERIMENTAL

Drug: roflumilast cream 0.3%

Reference product

ACTIVE COMPARATOR

Drug: Zoryve

Padagis placebo product

PLACEBO COMPARATOR

Drug: Placebo

Interventions

roflumilast cream 0.3% DRUG

test product

Padagis active product

Zoryve DRUG

Reference Listed Drug product

Reference product

Placebo DRUG

placebo

Padagis placebo product

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed IRB approved written informed consent/assent
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

DS Research

Louisville, Kentucky, 40241, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: February 7, 2023
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)