A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
855
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
Placebo (vehicle of the test product) to cover only the lesions with a thin film.
Treatment Success Assessed by IGA
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time frame: Week 12
Disease Severity None or Minimal on IGA
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time frame: Week 12
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fougera Investigational Site
Phoenix, Arizona, United States
Fougera Investigational Site
Hot Springs, Arkansas, United States
Fougera Investigational Site
Anaheim, California, United States
Fougera Investigational Site
North Hollywood, California, United States
Fougera Investigational Site
San Diego, California, United States
Fougera Investigational Site
San Ramon, California, United States
Fougera Investigational Site
Brandon, Florida, United States
Fougera Investigational Site
Coral Gables, Florida, United States
Fougera Investigational Site
Hialeah, Florida, United States
Fougera Investigational Site
Miami, Florida, United States
...and 20 more locations