NCT02070965已完成2 期
Randomized Parallel Group Open-Label Multicenter Study to Assess the Potential for Adrenal Supp and Syst Drug Abs Following Multi Dosing With DFD-01 (Betamethasone Dipropionate) Spray 0.05% in Adol Subjects With Mod to Sev Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- The Number of Subjects With HPA Axis Suppression
研究概览
简要总结
The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily for 15 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
- •Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- •Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit
- •Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA function or adrenal response. -
排除标准
- •Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
- •History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- •Have received treatment for any type of cancer within 5 years of the Baseline Visit except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the Baseline Visit.
- •Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea)
- •Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
- •Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
- •Subjects who have an abnormal sleep schedule or work at night.
- •Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
- •Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
研究组 & 干预措施
Comp01 Lotion
Active Comparator
Comp01 Lotion, bid, 14 days
干预措施: Comp01 Lotion (Drug)
DFD01 Spray Group 1
Experimental
DFD01 Spray, bid, 28 days
干预措施: DFD01 Spray (Drug)
DFD01 Spray Group 2
Experimental
DFD01 Spray, bid, 14 days
干预措施: DFD01 Spray (Drug)
结局指标
主要结局
The Number of Subjects With HPA Axis Suppression
时间窗: Day 15
次要结局
未报告次要终点
研究者
研究点 (12)
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