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Sorilux for Plaque Psoriasis
Phase 4
Waitlist Available
Led By Leon H Kircik
Research Sponsored by Skin Sciences, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening/baseline, week 2, week 8
Awards & highlights
Study Summary
This study is evaluating whether a combination of two medications may be more effective than either medication alone for treating psoriasis.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening/baseline, week 2, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening/baseline, week 2, week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
Secondary outcome measures
Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8
Change in Total Lesion Severity Score (TLSS) at week 2 and week 8
Change in Visual Analogue Scale (VAS) at week 2 and week 8
+1 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: SoriluxActive Control1 Intervention
Calcipotriol Foam (Sorilux Foam) for 6 weeks
Participants from Groups A and B who are clear or almost clear at the end of 2 weeks will be re-randomized into Groups 1 and 2.
Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 6 weeks. SORILUX Foam contains calcipotriene 50 mcg/g.
Group II: Lexette + SoriluxActive Control2 Interventions
Halobetasol Propionate Topical Foam (Lexette Foam) + Calcipotriol Foam (Sorilux Foam) for 2 weeks
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate.
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.
Group III: VehiclePlacebo Group1 Intervention
Vehicle Foam for 6 weeks.
Participants from Groups A and B who are clear or almost clear at the end of 2 weeks will be re-randomized into Groups 1 and 2.
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
Group IV: Lexette + VehiclePlacebo Group2 Interventions
Halobetasol Propionate Topical Foam (Lexette Foam) + Vehicle Foam for 2 weeks
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks. Each gram of Halobetasol Propionate Topical Foam contains 0.5 mg of halobetasol propionate.
Vehicle Foam would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application.
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Who is running the clinical trial?
Skin Sciences, PLLCLead Sponsor
Leon H KircikPrincipal InvestigatorSkin Sciences, PLLC
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