Comparison of Efficacy and Safety of Psoriatic Nails Treatment Between by Intralesional 0.1%Triamcinolone Injection and Topical 0.05%Clobetasol Propionate Ointment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percent change in the NAPSI (Nail Psoriasis Severit Index) score of psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment
研究概览
简要总结
Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails.
The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.
详细描述
Psoriasis is a chronic inflammatory disorder. The nails involvement has been reported up to 40% of psoriatic patients. Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis, discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of psoriatic nails is using topical high- potent steroids however topical steroids are limited their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of such a treatment can lead to skin atrophy and report in the case of "Disappearing digits". Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory results without any serious permanent adverse effects. At present, there is no comparison study between intralesional steroid and ultrapotent topical steroid for the treatment of psoriatic nails.
The purpose of the study is to evaluate the efficacy and safety of intralesional triamcinolone comparing to 0.05% clobetasol ointment in the treatment of psoriatic nails.
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
- 否
入选标准
- •Subjects aged over 18 years old who have at least 3 psoriatic finger nails resembly severity
排除标准
- •Patients are receiving the systemic therapy of psoriasis
- •Patients discontinued the systemic therapy less than 3 months and topical therapy less than 1 month
- •Positive results for the microscopic study of fungus in finger nails
- •History of steroids or EMLA allergy
- •Pregnancy or nursing
- •Any skin infection at the site of the treatment
- •Human immunodeficiency virus subjects
- •History of malignancy or during the treatment of malignancy
- •Patients who have psychological disorder
- •Patients who have bleeding disorder or receiving anticoagulation drugs
研究组 & 干预措施
triamcinolone injection (10 mg/ml)
Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection
干预措施: 0.1% triamcinolone , 0.05% clobetasol propionate ointment (Drug)
Topical 0.05% clobetasol ointment
Three finger nails are chosen from the equally average Targeted NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C Apply Topical 0.05% clobetasol propionate ointment on the nail fold twice daily for 6 months
干预措施: 0.1% triamcinolone , 0.05% clobetasol propionate ointment (Drug)
结局指标
主要结局
Percent change in the NAPSI (Nail Psoriasis Severit Index) score of psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment
时间窗: 6 months
1. To compare the percent change in the NAPSI (Nail Psoriasis Severity Index) score of Psoriatic nails after treatment with intralesional 0.1%triamcinolone injection vs.topical 0.05% clobetasol propionate ointment and controlled untreated group.
次要结局
- adverse effects of the intralesional steroid injection and topical 0.05% clobetasol propionate ointment(6 months)
研究者
chanisada tuchinda
Assistant Professor
Mahidol University