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Topical Agent

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Padagis LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 56
Awards & highlights
Pivotal Trial

Summary

This trial tests a new treatment from Padagis for patients with plaque psoriasis. It aims to see if it is as safe and effective as an already approved treatment. The treatment likely works by reducing inflammation and slowing down skin cell production.

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Investigator's Global Assessment (IGA)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Padagis active productExperimental Treatment1 Intervention
Group II: Reference productActive Control1 Intervention
Group III: Padagis placebo productPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
roflumilast cream 0.3%
2023
Completed Phase 3
~420

Find a Location

Who is running the clinical trial?

Padagis LLCLead Sponsor
36 Previous Clinical Trials
20,435 Total Patients Enrolled

Media Library

roflumilast cream 0.3% (Topical Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05763082 — Phase 3
Plaque Psoriasis Research Study Groups: Padagis active product, Reference product, Padagis placebo product
Plaque Psoriasis Clinical Trial 2023: roflumilast cream 0.3% Highlights & Side Effects. Trial Name: NCT05763082 — Phase 3
roflumilast cream 0.3% (Topical Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763082 — Phase 3
~146 spots leftby Dec 2025
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