CTRI/2018/08/015360已完成3 期
A Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlledclinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz andplacebo in patients with mild to moderate plaque psoriasis. - CRSC16004
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients (Non-pregnant) aged 18 to 65 years having either Fitzpatrick skin type Iâ??III or IVâ??VI.
- •2. Diagnosis of plaque psoriasis by a dermatologist with lesions on arms, legs
- •3. Patients with stable plaque psoriasis for 6 months, mild to moderate form on Physicianâ??s global assessment (PGA), Body Surface Area (BSA) involvement of 5-10% (both included) and PASI >= 5.
- •4. Patients must be willing to provide written informed consent.
- •5. Patients must be willing and able to understand and can comply with study requirements, apply the medication as instructed and be able to complete the study.
排除标准
- •1.Predominantly palmo-plantar, flexural, scalp and nail location of psoriasis.
- •2.Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
- •3.Pregnant, nursing Female patient.
- •4.Women of childbearing potential must use reliable forms of contraception.
- •5.Patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- •6.Patient with positive serology tests like HIV, HCV & HBsAg.
- •7.Patient with presence of any skin disease that might interfere with the diagnosis or evaluation of the test medications.
- •8.Patient with condition or situation, which may put him/her at significant risk, may confound study results, or may interfere significantly with participation in the study.
- •9.Patient with spontaneously improving or rapidly deteriorating plaque psoriasis.
- •10.Use of systemic agents such as oral retinoids, methotrexate, cyclosporine or systemic corticosteroids within four weeks prior to screening.
- •11.Use of biologic agents such as alefacept, infliximab, efalizumab, adalimumab, etanercept, certolizumab, golimumab, ustekinumab or secukinumab within four weeks prior to study entry.
- •12.Use of topical drugs that might alter the course of psoriasis or has received ultraviolet B treatment within two weeks prior to study entry. Use of phototherapy with psoralen ultraviolet A treatment within four weeks prior to study entry.
- •13.Patient with a known sensitivity to any of the study treatments and/or their components.
- •14.Patient who anticipates a need to use other topical or systemic therapy that might alter course of psoriasis and need for surgery or hospitalization during the study.
- •15.Participation in other clinical study within 30 days prior to entering the study.
研究者
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