Efficacy and Safety of Sorilux in Maintenance Treatment of Moderate Type Plaque Psoriasis After Combination Treatment of Lexette and Sorilux for 2 Weeks
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind study. Medication's label will be covered. Only the study coordinator would be able to identify the medication.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;
- •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.]
- •Subjects with moderate plaque type psoriasis.
- •Physician Global Assessment (PGA) score of
- •Able to understand study requirements and sign Informed Consent/HIPAA forms.
- •Target lesion must be at least 2cm in diameter
排除标准
- •Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study.
- •History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease
- •Patients with guttate, erythrodermic, or pustular psoriasis
- •Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).
- •Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis.
- •Known hypersensitivity to Lexette or Sorilux Foam or any of its components.
- •Current drug or alcohol abuse (Investigator opinion).
- •Subject unable to commit to all the assessments required by the protocol.
- •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.
研究组 & 干预措施
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.
干预措施: Sorilux 0.005 % Topical Foam (Drug)
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.
干预措施: LEXETTE 0.05% Topical Foam (Drug)
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.
干预措施: Sorilux 0.005 % Topical Foam (Drug)
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.
干预措施: LEXETTE 0.05% Topical Foam (Drug)
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.
干预措施: Vehicle Foam (Other)
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.
干预措施: Vehicle Foam (Other)
结局指标
主要结局
Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 8
时间窗: Week 8
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
次要结局
- Percent of subjects who maintain clear or almost clear on Physician Global Assessment (PGA) at Week 2(Week 2)
- Change in Dermatology Life Quality Index (DLQI) at week 2 and week 8(Screening/Baseline, Week 2, Week 8)
- Change in Visual Analogue Scale (VAS) at week 2 and week 8(Screening/Baseline, Week 2, Week 8)
- Change in Total Lesion Severity Score (TLSS) at week 2 and week 8(Screening/Baseline, Week 2, Week 8)
研究者
Leon H. Kircik, MD
Medical Director
Skin Sciences, PLLC