NCT01967069已完成3 期
A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 28
- 主要终点
- Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
研究概览
简要总结
The objectives of this study are to compare the efficacy and safety of DFD01 Spray to Vehicle Spray for topical treatment of moderate 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
- Double (Participant, Investigator)
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
- •Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
- •Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
- •Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit
排除标准
- •Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
- •Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
- •History of psoriasis unresponsive to topical treatments. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
- •Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).
- •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 within 1 year of the Baseline Visit.
- •Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).
- •Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, and intranasal steroids are allowed.
- •Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.
- •Require use of beta blockers, lithium, ACE inhibitors, and/or NSAIDs (indomethacin, ibuprofen, aspirin, naproxen) with a medical history that these medications affect the subject's psoriasis, except if the subject has been using the medication routinely during the 180 days prior to the Baseline Visit, these medications are allowed.
研究组 & 干预措施
Vehicle Spray
Placebo Comparator
Vehicle Spray twice daily
干预措施: Vehicle Spray (Drug)
DFD01 Spray
Active Comparator
DFD01 Spray twice daily
干预措施: DFD01 Spray (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)
时间窗: Day 15
IGA of clear or almost clear
次要结局
未报告次要终点
研究者
研究点 (28)
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