A Multicentric, assessor-blind, randomized, active controlled, parallel design study comparing efficacy and safety of clobetasol propionate topical foam 0.05% vs. clobetasol propionate lotion 0.05% in patients with mild to moderate plaque type psoriasis (scalp and non-scalp)

Torrent Pharamceutical Ltd0 个研究点目标入组 232 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 232

研究概览入排标准研究者记录与标识符相似试验

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 and female patients of age 18 years or older.
•2.Patients with mild to moderate plaque-type psoriasis, as defined by ISGA score of 2-3 at enrolment involving <=10 % of total body surface area.
•3.Patients must have a target lesion ( >2 cm2) with a score of 2-3 (on a scale of 0 to 5) for each of erythema, scaling and plaque thickness.
•4.Patients with ability and willingness to follow the study procedures attend all scheduled visits and successfully complete the study.
•5.Patients willing to give informed consent

排除标准

•1.Patients with known allergy or sensitivity to clobetasol or other topical corticosteroids or any other component of investigational formulation.
•2.Patients whose psoriasis involves the face, nails, palms, soles or intertriginous sites.
•3.Severe, uncontrolled manifestation of any disease including psoriasis.
•4.Use of systemic antipsoriatic therapy (e.g., corticosteroids, retinoids, methotrexate, psoralen and ultraviolet light, cyclosporine) within the past 4 weeks
•5.Patients who have taken or currently on biologics treatment such as e.g., alefacept, etanercept, adalimumab.
•6.Use of topical treatment which have a known beneficial effect on psoriasis, including but not limited to corticosteroid, retinoids, vitamin D derivatives, tar or anthralin within the past 2 weeks.
•7.Introduction or change in dosage of systemic medications for other medical conditions which are known to affect psoriasis (e.g., lithium, Î²-blockers etc.) within the past 4 weeks.
•8.The expectation of exposure to strong sunlight or UV therapy during the course of the study; or any condition that, in the judgment of the investigator, would put the patient at unacceptable risk for participation in the study.
•9.Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
•10.History of malignancy in last 5 years.
•11.Current drug or alcohol abuse.
•12.Patient with clinically significant abnormal laboratory investigation.
•13.Use of any investigational drug or device therapy within the past 4 weeks.
•14.Pregnant women, women who are breast feeding or women of reproductive potential who are neither surgically sterilized nor willing to use effective contraceptive methods during the course of the study.
•15.Men wishing to father a child during the course of the study or not ready to use adequate means of contraception throughout the study.
•16.Patient who in the opinion of the investigator would not be suitable candidate for participation in the study.

研究者

发起方

Torrent Pharamceutical Ltd

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