A Randomized, Open Label, Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption With DFD-06 Cream Versus Clobetasol Propionate Cream, 0.05% in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- The Percentage 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 DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.
详细描述
This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.
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% Body Surface Area (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 Adrenocorticotropic hormone (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) psoralen and ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (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
Clobetasol Propionate Cream, 0.05%
applied twice a day for 15 days
干预措施: Clobetasol Propionate Cream 0.05% (Drug)
DFD06 Cream
applied twice a day for 15 days
干预措施: DFD06 Cream (Drug)
结局指标
主要结局
The Percentage of Subjects With HPA Axis Suppression.
时间窗: Day 15
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
次要结局
未报告次要终点