NCT01938599已完成2 期
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing AM001 Cream to Vehicle in the Treatment of 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
- 发起方
- AmDerma
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Investigator's Global Assessment of Disease Severity (IGA)
研究概览
简要总结
To compare the safety and efficacy profile of AM001 Cream and its vehicle in the treatment of 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
- Triple (Participant, 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
- •Subjects must provide Institutional Review Board (IRB) approved written informed consent.
- •Subjects must be male or female, at least 18 years of age.
- •Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for at least 3 months), involving at least 3% and up to 20% of the body surface area (not including the scalp, face, hands, feet, and intertriginous areas).
- •Subjects with an Investigator's Global Assessment (IGA) of disease severity of at least moderate severity (score ≥ 3) as an overall assessment.
- •Subjects with a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3) at the target lesion site.
- •If females of childbearing potential, the subject must have a negative urine pregnancy test, and must have been using an acceptable form of birth control for at least two months prior to Screening and are willing to continue birth control throughout the study.
- •Subjects must be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
- •Subjects must be in good health, as confirmed by medical history and physical exam, and free from any clinically significant disease/condition, other than plaque psoriasis, that might interfere with the study evaluations.
- •Subjects must be willing to limit sun exposure overall. Subjects are prohibited from sunbathing or intentional tanning or intense sun exposure including the use of tanning booths/lights or other artificial UV light sources throughout the study.
排除标准
- •Female subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or erythrodermic psoriasis.
- •Subjects who have a history of psoriasis unresponsive to topical treatments.
- •Subjects who have a history of a disorder that may interfere with the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis, cutaneous lymphoma, etc.).
- •Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- •Subjects with unstable medical disorders, life-threatening disease, or current malignancies.
- •Subjects with clinically significant ECG or laboratory abnormalities at Screening (as determined by the Investigator).
- •Subjects who are immunosuppressed.
- •Subjects who have a history of allergy or a known hypersensitivity to any component of the study medication.
- •Subjects who have been treated with any systemic steroids within the 4 weeks prior to the study entry.
- •Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT), lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-mercaptopurine (6-MP), or etanercept.
- •Subjects who have been treated with biologic therapy other than etanercept within 8 weeks prior to study entry. Vaccines will not be considered an exclusionary biologic treatment.
- •Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid, anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene), topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to study entry.
- •Subjects who have been treated with lithium, antimalarial agents, or quinidine within the 4 weeks prior to study entry.
- •Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken any immunosuppressant medication within 3 months prior to study entry.
研究组 & 干预措施
AM001
Experimental
AM001 Cream, 7.5%. 2x daily for 12 weeks.
干预措施: AM001 Cream, 7.5% (Drug)
Vehicle
Placebo Comparator
Placebo of AM001 Cream. 2x daily for 12 weeks.
干预措施: Placebo of AM001 Cream (Drug)
结局指标
主要结局
Investigator's Global Assessment of Disease Severity (IGA)
时间窗: Week 12
An overall assessment of disease severity will be performed at each study visit.
次要结局
- Body Surface Area (BSA)(12 Weeks)
- Dermatology Life Quality Index (DLQI)(12 Weeks)
- Target Lesion Psoriasis Area Severity Index (PASI)(12 Weeks)
- Pharmacokinetics(2 Weeks)
- Target Lesion Area(12 Weeks)
研究者
研究点 (5)
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