临床试验/NCT00232115

NCT00232115已完成3 期

Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Novartis1 个研究点分布在 1 个国家目标入组 124 人开始时间: 2005年9月最近更新: 2008年1月17日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 124
试验地点: 1
主要终点: Reduction of the Perioral Dermatitis Severity Index

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.

This study is not enrolling patients in the United States.

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: Double (Participant, Investigator)

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

•clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
•minimum severity score (PODSI) ≥ 4
•age 18 and older

排除标准

•Ongoing use of the following treatments is NOT allowed after the start of study drug:
•Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).
•Systemic immunosuppression
•History of malignancy of any organ system, treated or untreated, within the past 5 years

研究组 & 干预措施

1

Experimental

Pimecrolimus

干预措施: Pimecrolimus (Drug)

2

Placebo Comparator

Vehicle

干预措施: Placebo (Drug)

结局指标

主要结局

Reduction of the Perioral Dermatitis Severity Index

次要结局

Time to disease recurrence
Response rates
Patient's quality of life assessment
Patient's disease severity assessment

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

Loading locations...

相似试验

已完成

4 期

Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-oldAtopic Dermatitis

NCT00510003Novartis Pharmaceuticals117

已完成

4 期

Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic DermatitisAtopic Dermatitis

NCT00150059Novartis

已完成

3 期

5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic DermatitisAtopic Dermatitis

NCT00120523MEDA Pharma GmbH & Co. KG2,418

已完成

2 期

Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic DiseasePrurigo Nodularis

NCT00507832University Hospital Muenster30

已完成

4 期

Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) PatientsAtopic Dermatitis

NCT00121316Novartis200