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临床试验/NCT03263624
NCT03263624Unknown4 期

Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic: Nail Disease a Single-blind, Intrapatient Left-to-right Controlled Study.

Assiut University0 个研究点目标入组 30 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
30
主要终点
percentage of clinically improved patients using modified nail psoriasis severity index.

研究概览

简要总结

Nail psoriasis has a high incidence amongst patients with psoriasis.It is estimated to affect 80% of psoriatic patients at some time during their lives and has a significant adverse influence on their quality of life.

Treatment of nail psoriasis is disappointing, as it is refractory to treatment, with conventional therapies often having little effect.

详细描述

The characteristic lesions affecting the nail present as 'oil drop' discoloration, splinter haemorrhages, subungual hyperkeratosis, and onycholysis in the nail bed or pitting, leuconychia, erythema of the lunula and crumbling in the nail matrix.Diagnosis is customarily made by patient history and physical examination, though it may be necessary to rule out onychomycosis as a differential diagnosis.

The nail psoriasis severity index has recently been reported as a possible reproducible, objective, and simple tool for clinical assessment of psoriatic nail disease.

The modified target nail psoriasis severity index has been proposed for target nail assessment which would give a degree of gradation for each parameter of 0 to 3 (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in each quadrant.The topical therapies include topical and intralesional corticosteroids , topical vitamin D3 analogues (calcipotriol) , topical tacrolimus and tazarotene[8]. The efficacy of these topical therapies in nail disease is limited mainly by the impenetrability or low penetrability of the nail and nail matrix. In patients with nail psoriasis that is resistant to topical therapies, conventional systemic therapies (e.g., phototherapy, retinoids, cyclosporine, methotrexate) have been shown to be partially effective. More recently, biological therapies (e.g., infliximab, adalimumab, alefacept, etanercept) have proven efficacy in psoriasis and psoriatic arthritis, and some are effective in treating nail disease in patients with psoriasis .

Previous study proved successful treatment of onychodystrophy using fractional carbon dioxide laser with topical steroid. Fractional Carbon dioxide laser might be an effective therapy for nail psoriasis due to its ablative ability which produce microscopic holes that perhaps improve topical drug delivery. Moreover it was hypothesized that tissue ablation and remodelling process stimulate rejuvenation of the abnormal nail bed.The investigators hypothesized that the combination of Fractional carbon dioxide laser and topical tazarotene treatment will have a higher therapeutic effect on nail psoriasis through multiple mechanism.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Thirty patients with bilateral fingernail psoriasis will be recruited from the Dermatology Outpatient Clinic, Assiut University Hospital.
  • The diagnosis will be based upon the clinical characteristics of nail psoriasis.
  • Patients will be included after they have stopped any systemic therapy for at least 8 weeks

排除标准

  • pregnant or lactating woman
  • patients with history of photosensitivity.
  • Patients who discontinued or just started to receive new systemic therapy or phototherapy during the study period will be dropped from the study.

研究组 & 干预措施

Group (A)

Experimental

fractional carbon dioxide laser plus tazarotene 0.1% cream

干预措施: fractional carbon dioxide laser (Device)

Group (A)

Experimental

fractional carbon dioxide laser plus tazarotene 0.1% cream

干预措施: Tazarotene Cream 0.1% (Drug)

Group (B)

Active Comparator

Tazarotene Cream 0.1%

干预措施: Tazarotene Cream 0.1% (Drug)

结局指标

主要结局

percentage of clinically improved patients using modified nail psoriasis severity index.

时间窗: three months

clinical assessment using modified nail psoriasis severity index.

次要结局

未报告次要终点

研究者

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

Ayat Mahmoud

Principal Investigator

Assiut University

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