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临床试验/NCT02191748
NCT02191748终止2 期

Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
22
试验地点
1
主要终点
Repigmentation of vitiligo patch using confocal microscopy

研究概览

简要总结

Vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. In the United States, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. Current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. Unfortunately, some cases of vitiligo are refractory to treatment. There is a need for new, effective modalities to treat patients with otherwise refractory vitiligo.

Needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. Two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results.

The proposed randomized control trial (RCT) will further investigate the use of needling to treat vitiligo. It differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. Confocal microscopy (CFM) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. This study would be the first RCT of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of CFM for monitoring response to treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with 3 or more localized patches of stable vitiligo
  • No prior treatment or had failed previous vitiligo treatments

排除标准

  • Unstable vitiligo
  • Allergic to triamcinolone
  • Systemic treatments

研究组 & 干预措施

Needling

Active Comparator

Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch. Saline, which doesn't affect repigmentation in vitiligo, will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of saline injected at each site.

干预措施: Needling (Procedure)

Needling and Triamcinolone

Experimental

During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.

干预措施: Needling (Procedure)

Needling and Triamcinolone

Experimental

During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area. Triamcinolone (concentration: 2.5 mg/cc) will be injected into the patch at multiple sites spaced approximately 1 cm apart with 0.1-0.2 cc of triamcinolone injected at each site.

干预措施: Triamcinolone (Drug)

结局指标

主要结局

Repigmentation of vitiligo patch using confocal microscopy

时间窗: week 28 post treatment

次要结局

  • Photography measure to assess repigmentation(week 28 post treatment)
  • Wood's lamp to assess repigmentation(week 28 post treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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