Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Plaque Psoriasis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Subjects will be randomized to study treatment at a 1:1 ratio: of Lexette plus Sorilux for 2 weeks versus Lexette plus vehicle for 2 weeks. Those subjects who are clear or almost clear at the end of 2 weeks will be re-randomized into Sorilux for 6 weeks versus vehicle for 6 weeks at 1:1 ratio.Masking: Double (Participant, Investigator)Masking Description: This is a double-blind study. Medication's label will be covered. Only the study coordinator would be able to identify the medication.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a single-center, double-blind study. Approximately 30 qualified subjects will be enrolled into a 8 weeks study. The study drugs that will be used in this study are Lexette® (0.05% Halobetasol propionate foam) and Sorilux® (calcipotriene foam). Both Lexette and Sorilux are approved by the Uni...
This is a single-center, double-blind study. Approximately 30 qualified subjects will be enrolled into a 8 weeks study. The study drugs that will be used in this study are Lexette® (0.05% Halobetasol propionate foam) and Sorilux® (calcipotriene foam). Both Lexette and Sorilux are approved by the United States Food and Drug Administration (FDA) to treat psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio: of Lexette plus Sorilux for 2 weeks versus Lexette plus vehicle for 2 weeks. Those subjects who are clear or almost clear at the end of 2 weeks will be re-randomized into Sorilux for 6 weeks versus vehicle for 6 weeks at 1:1 ratio. Subjects will attend a Screening Visit/Baseline visit and if found eligible will be randomized to study treatment. Total study period is 8 weeks. Study visits will be, screening/baseline, week 2 and week 8. Study assessments will be at each visit: BSA, PGA, Itch VAS, DLQI, and TLSS in addition to standard medical assessments. There will be a standard prohibited medication/treatment and washout periods.
Tracking Information
- NCT #
- NCT04571151
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Leon H Kircik Skin Sciences, PLLC