Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The repigmentation rate (change from baseline) of the vitiliginous patch
研究概览
简要总结
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
详细描述
Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention.
The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 19 or older
- •A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
- •A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
- •A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo
排除标准
- •Patients under the age of 19
- •Patients with enlarged or spreading lesions of vitiligo
- •Patients who do not want to do so or who refuse to write a consent form
- •Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
- •Others those who are deemed unsuitable for the examination at the discretion of the examiner
研究组 & 干预措施
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
干预措施: Triamcinolone acetonide 0.4mg/cc (Drug)
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
干预措施: Phototherapy (NBUVB or excimer laser) (Device)
Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
干预措施: Topical tacrolimus (Drug)
Control group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
干预措施: Phototherapy (NBUVB or excimer laser) (Device)
Control group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
干预措施: Topical tacrolimus (Drug)
结局指标
主要结局
The repigmentation rate (change from baseline) of the vitiliginous patch
时间窗: Baseline and 12 weeks
The degree of repigmentation will be assessed as % from baseline by using a computer program.
次要结局
- The adverse effects(every weeks up to 13 weeks)
研究者
Jung Min Bae
Assistant Professor
The Catholic University of Korea