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Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type 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
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial 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