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临床试验/NCT00723437
NCT00723437已完成4 期

Evaluation of Nail Psoriasis Severity Index (NAPSI) and Modified Napsi in Patients With Nail Psoriasis Treated With Acitretin

Istituti Fisioterapici Ospitalieri2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2005年1月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
correlate clinical improvement with % reduction in the NAPSI Score

研究概览

简要总结

Objective:

Efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively. Evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis.

Design:

Open-study on thirty-six patients with moderate to severe nail psoriasis treated with acitretin.

Participants:

Patients included 27 men and 9 women (mean age 41) with nail psoriasis. Intervention: Therapy consisted of acitretin 0.2 to 0.3 mg/Kg/day for 6 months.

Main Outcome Measure(s):

Clinical evaluation, NAPSI and modified NAPSI scores before therapy, every 2 months during therapy and 6 months after treatment.

详细描述

The Nail Psoriasis Severity Index (NAPSI) has been designed and successfully implemented to grade severity of psoriatic nail disease. Moreover, the utilization of the NAPSI score and a modified version of this severity index score as an instrument to monitor response to therapy has been recently documented in the medical literature .This open study involves thirty-six patients with moderate to severe nail psoriasis treated with low-dose acitretin from January 2005 to January 2007.Acitretin was given at the dosage of 0.2 to 0.3 mg/Kg/day for 6 months. Laboratory investigations and clinical evaluation, which included photographic record and scoring of NAPSI and modified NAPSI, were performed every 2 months. Investigator evaluation was performed using a 0 (no improvement) to 3 (cleared or almost cleared) score Treatment satisfaction by patients and tolerability were assessed at each visit. All patients were followed for at least 6 months after the end of treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with moderate to severe nail psoriasis

排除标准

  • premenopausal women
  • patients with hepatic, renal or metabolic diseases
  • patients with skin or symptomatic arthropathic psoriasis
  • previous systemic treatment for nail psoriasis

结局指标

主要结局

correlate clinical improvement with % reduction in the NAPSI Score

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Istituti Fisioterapici Ospitalieri
申办方类型
Other

研究点 (2)

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