CTRI/2020/03/023715已完成4 期
To compare the safety and efficacy of sequential therapy with topical tazarotene and calcitriol versus monotherapy of tazarotene and calcitriol in patients with stable plaque psoriasis
nil0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Males or non pregnant females 18 years of age or older.
- •Subjects with a clinical diagnosis of stable plaque psoriasis of atleast 3 months.
- •Subjects with 5 to 10 percent Body surface area involvement.
- •Lesions did not include the face, scalp, groin, hands and feet.
- •Subjects able to complete the study and to comply with study instructions.
- •Subjects willing to give written informed consent.
排除标准
- •Females who were pregnant, lactating or planning a pregnancy.
- •Current diagnosis of unstable forms of psoriasis in the treatment area including guttate,erythrodermic,exfoliative or pustular psoriasis.
- •Other inflammatory skin disease in the treatment area that confounded the evaluation of the plaque psoriasis ,for example atopic dermatitis,contact dermatitis,tinea corporis.
- •Presence of pigmentation, extensive scarring or pigmented lesions in the treatment areas,which could interfere with the rating of efficacy parameters.
- •History of psoriasis unresponsive to topical treatments.
- •History of hypersensitivity to any component of the test product or reference listed drug.
- •Current or past history of hypercalcemia,vitamin D toxicity,severe hepatic disorders.
- •Current immunosuppression.
- •Use within one month prior to baseline of systemic steroids,systemic antibiotics,systemic antipsoriatic treatment,PUVA therapy,UVB therapy or systemic anti-infammatory agents,calcium supplements.
- •Use within 2 weeks prior to baseline of topical anti-psoriatic drugs(for example-salicylic acid,anthralin,coaltar,calcipotriene,tazarotene), topical corticosteroids,immunosuppressive drugs(for example- tacrolimus,pimecrolimus),or topical retinoids.
- •Use of topical products other than the assigned treatment (including moisturizers,new brands of make-up,creams,ointments,lotions and powders)applied on or near the treatment area.
- •Initiation of or changes to non antipsoriatic concomitant medication that could affect psoriasis (for example-beta blockers,lithium) during study.
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