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临床试验/NCT01333410
NCT01333410Unknown4 期

Comparison the Efficacy and Safety of 0.1% Tacrolimus Ointment With 0.1% Mometasone Furoate Cream in the Treatment of Adult Vitiligo: A Single Blinded Pilot Study

Mahidol University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
percent of repigmentation

研究概览

简要总结

Vitiligo has remained a difficult disease to treat. Previous available therapies are often ineffective. It usually takes several months or years for complete repigmentation and some areas of the body get at best only partial repigmentation. The desire of the patient to undergo therapy varies from patient to patient and needs to be assessed individually. Several factors should be considered when planning the treatment strategies including type of vitiligo, site and degree of involvement, skin color, psychological effect, patient compliance, ease to assess to therapy, cost of treatment and social association of the disease.

Topical corticosteroids are still be the standard treatment of localized vitiligo. However, the adverse effects such as skin atrophy, striae, pigmentary change and hypothalamic-pituitary adrenal axis suppression can occur if we use inappropriate strength of topical steroids for a long period of time.

Tacrolimus (FK-506) is a new immunosuppressive agent that acts by inhibiting T-cell activation and cytokine release. It offers a safe and efficacious alternative for many skin conditions. It minimizes the need for topical glucocorticoids and does not cause skin atrophy. Tacrolimus was first reported for treatment of vitiligo in 2002. The underlying mechanism was shown in an in vitro study that topical tacrolimus promoted proliferation of melanocytes and melanoblasts.

This study purpose is to evaluate the efficacy and safety of 0.1% topical tacrolimus ointment comparing to 0.1% mometasone furoate cream in the treatment of adult vitiligo.

详细描述

At first visit, patients will be randomized to receive 0.1% tacrolimus ointment for apply to vitiligo lesion on one side of the body. The lesion on the other side of the body will be treated with 0.1% mometasone furoate cream. Patients are instructed to apply 0.1% tacrolimus ointment and 0.1% mometasone furoate cream twice a day for 6 months

Patients will be follow up at 2, 4 and 6 months for clinical improvement, side effects and photographs

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients must be above 18 years old
  • Patients must have symmetrical vitiligo lesion on both sides of the body. Total vitiligo area is not exceeded 5% of the body surface area
  • Discontinue any previous systemic medication or phototherapy for at least 3 months and discontinue any topical medication for at least 1 month before starting the study

排除标准

  • Patient who have the lesion on acral area (hands or feet)
  • Pregnancy or lactation patient

研究组 & 干预措施

0.1% tacrolimus ointment

Active Comparator

干预措施: tacrolimus ointment (Drug)

0.1% mometasone furoate cream

Active Comparator

干预措施: Mometasone furoate (Drug)

结局指标

主要结局

percent of repigmentation

时间窗: 6 months

Percent of patients who get repigmentation of the lesion after 0.1% tacrolimus ointment VS 0.1% mometasone furoate cream Percent of repigmentation is defined as following * No improvement (0 % repigmentation) * Improved by 1-25% repigmentation * Improved by 26-50% repigmentation * Improved by 51-75% repigmentation * Improved by 76-100% repigmentation

次要结局

  • side effect(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

chanisada tuchinda

Assistant Professor

Mahidol University

研究点 (1)

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