A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
研究概览
简要总结
The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
- •Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
- •Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
- •The target lesion must have an area of at least 5 cm².
- •Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
排除标准
- •Pregnancy
- •Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
- •History of psoriasis that has been unresponsive to topical corticosteroid therapy.
- •Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
- •Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
- •Any condition that would place the study patient at undue risk by participation in the study.
- •Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
- •Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
- •Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
- •Systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
- •Hormonal contraceptives for less than one complete cycle prior to entering the study.
- •Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
- •Receipt of any drug as part of a research study within 30 days prior to first dosing.
研究组 & 干预措施
Desoximetasone 0.05% once daily
Desoximetasone topical spray 0.05% administered once daily to affected area
干预措施: Desoximetasone 0.05% once daily (Drug)
Desoximetasone 0.05% twice daily
Desoximetasone topical spray 0.05% administered twice daily to affected area
干预措施: Desoximetasone 0.05% twice daily (Drug)
Desoximetasone 0.25% once daily
Desoximetasone topical spray 0.25% administered once daily to affected area
干预措施: Desoximetasone 0.25% once daily (Drug)
Desoximetasone 0.25% twice daily
Desoximetasone topical spray 0.25% administered twice daily to affected area
干预措施: Desoximetasone 0.25% once daily (Drug)
Vehicle once daily
Vehicle administered to affected areas once daily
干预措施: Vehicle once daily (Drug)
Vehicle twice daily
Vehicle administered to affected areas twice daily
干预措施: Vehicle twice daily (Drug)
结局指标
主要结局
Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
时间窗: 28 days
The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is \> 1, the patient was considered to have an insufficient therapeutic response
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
时间窗: Day 28
The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.
次要结局
- Mean Change From Baseline in PGA Score at Day 28 Using the ITT(Day 28)
- Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28(Day 28)
- Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).(Day 28)