Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis
NCT ID: NCT04571151
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-01-31
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Lexette + Sorilux
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.
LEXETTE 0.05% Topical Foam
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
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.
Lexette + Vehicle
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.
LEXETTE 0.05% Topical Foam
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
Vehicle Foam
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
Sorilux
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.
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.
Vehicle
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.
Vehicle Foam
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
Interventions
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LEXETTE 0.05% Topical Foam
Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
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.
Vehicle Foam
Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
A female is considered of childbearing potential unless she is:
\- postmenopausal \> 5Y, without a uterus and/or both ovaries; or has been surgically sterile for \> 6M.
Reliable methods of contraception are:
\- hormonal methods or IUD in use \> 90d prior to study drug administration, barrier methods plus spermicide in use \> 14d prior, or vasectomized partner.
\[Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\]
2. Subjects with moderate plaque type psoriasis.
3. Physician Global Assessment (PGA) score of 3.
4. Able to understand study requirements and sign Informed Consent/HIPAA forms.
5. Target lesion must be at least 2cm in diameter
Exclusion Criteria
2. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease
3. Patients with guttate, erythrodermic, or pustular psoriasis
4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
5. Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis.
6. Known hypersensitivity to Lexette or Sorilux Foam or any of its components.
7. Current drug or alcohol abuse (Investigator opinion).
8. Subject unable to commit to all the assessments required by the protocol.
9. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.
18 Years
ALL
Yes
Sponsors
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Skin Sciences, PLLC
OTHER
Responsible Party
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Leon H. Kircik, MD
Medical Director
Principal Investigators
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Leon H Kircik
Role: PRINCIPAL_INVESTIGATOR
Skin Sciences, PLLC
Locations
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Skin Sciences, PLLC
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Senen Pena
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LEX-2001
Identifier Type: -
Identifier Source: org_study_id