Study of Topical Calcitriol in Children With Psoriasis

National Center for Research Resources (NCRR)0 个研究点目标入组 20 人开始时间: 2000年7月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 20

研究概览研究设计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

OBJECTIVES:

I. Determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.

详细描述

PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily.

Patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while on study. Blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 4 Years 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•PROTOCOL ENTRY CRITERIA:
•-Disease Characteristics--
•Diagnosis of psoriasis At least 2 lesions with area at least 30-50 cm2
•-Prior/Concurrent Therapy--
•No other concurrent therapy for psoriasis No concurrent calcium supplements greater than 1,000 mg/day No concurrent prednisone or other drugs affecting serum or urine calcium levels
•-Patient Characteristics--
•Renal: No high blood or urinary calcium levels
•Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception

排除标准

未提供

研究者

发起方

National Center for Research Resources (NCRR)

申办方类型

Nih

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1 期

Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areas The face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline. The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris

EUCTR2007-004782-18-GBEO Pharmaceuticals Products Ltd. A/S (LEO Pharma A/S)1,225

进行中（未招募）

不适用

Calcipotriol Plus Hydrocortisone in Psoriasis Vulgarison the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.Psoriasis vulgaris on the face and on the intertriginous areasThe face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum.MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

EUCTR2007-004782-18-SIEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)1,225