Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Padagis LLC
Study ID
NCT05763082
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • roflumilast cream 0.3% — DRUG
    test product
  • Zoryve — DRUG
    Reference Listed Drug product
  • Placebo — DRUG
    placebo

Study Details

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

Key Dates

Start date
Feb 7, 2023
Status verified
Aug 2024
Primary completion
Aug 8, 2023
Completion
Aug 8, 2023

Study Design

Enrollment
414 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Padagis active product
  • Active Comparator: Reference product
  • Placebo Comparator: Padagis placebo product

Primary Outcome Measure

Investigator's Global Assessment (IGA) [ Time Frame: Day 1 to Day 56 ]

Locations (1)

FacilityCityStateZIPSite coordinators
DS ResearchLouisvilleKentucky40241-

Find similar trials in Louisville, KY

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
DS Research· Louisville, KY

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