NCT04571151

Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis

Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis After Combination Treatment of Lexette and Sorilux for 2 Weeks

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Skin Sciences, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study seeks to show whether there is additional benefit of using Lexette and Sorilux in the beginning of the treatment, and then maintenance treatment of Sorilux alone in moderate plaque type psoriasis patients.

Detailed 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 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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	LEXETTE 0.05% Topical Foam	Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
DRUG	Sorilux 0.005 % Topical Foam	Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application. SORILUX Foam contains calcipotriene 50 mcg/g.
OTHER	Vehicle Foam	Vehicle Foam would be applied over the affected area twice daily for 6 weeks.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-09-30
• Last updated: 2020-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study