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Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

NCT05763082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2024-08-12

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

roflumilast cream 0.3%

test product

DRUG

Zoryve

Reference Listed Drug product

DRUG

Placebo

placebo

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2023-08-08
Completion
2023-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763082 on ClinicalTrials.gov