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临床试验/NCT05699499
NCT05699499已完成不适用

Analysis of Impact of KeryFlex on Quality of Life for Retronychia or Lichen Planus Adult Patients

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Change in social domain of quality of life, as measured by social domain scale

研究概览

简要总结

The purpose of this study is to assess the overall effect of KeryFlex study intervention on quality of life and functionality for patients with retronychia or nail lichen planus.

详细描述

Retronychia is the growth of the proximal nail plate into the proximal nail fold which was first described in 1999 by De Berker and Rendall. The disorder is common and most frequently affects women (~82%); the estimated average age is 39 years. The unilateral hallux is the most commonly diagnosed site, though nails of the hand (especially thumb and index finger) may also be affected. Common triggers of retronychia include minor trauma (e.g., wearing poorly fitting shoes, jogging,) and systemic illness (e.g., arthritis, thrombophlebitis), which cause disruption of the longitudinal nail bed growth and ultimately lead to the new plate growing vertically into the proximal nail fold. The most frequent cause is trauma. Clinical symptoms include pain, inflammation of the proximal nail fold, granulation tissue under the proximal nail fold, and changes in the proximal nail plate such as thickening or yellowing. Diagnosis is confirmed by clinical presentation and ultrasound. Treatment is particularly challenging. Topical corticosteroids have been used with favorable results; however, recurrences are frequent. Complete nail avulsion is used for severe and/or recalcitrant cases, but this is also associated with frequent relapse rates.

Lichen planus is a chronic inflammatory dermatosis involving mucocutaneous surfaces, scalp, and nails. Nail involvement is observed in around 10% of patient and typically affects the fingernails more than toenails. Nail lichen planus can cause extensive scarring and nail loss. Permanent dystrophy in the forms of anonychia and dorsal pterygium has both functional and psychological consequences. Diagnosis is typically clinical, but a punch biopsy of the nail matrix or nail bed may be utilized if a diagnosis is questionable. There is no evidence-based management for nail lichen planus to date, though expert consensus recommends intralesional steroid injections or systemic corticosteroids as first-line treatment. Outcomes are inconsistent with steroid treatment.

KeryFlex nail is defined as a cosmetic by the Food and Drug Administration (FDA). KeryFlex is a painless, in-office aesthetic application of acrylic nails which improves the appearance of nails damaged by various nail disorders. The composite resin creates a flexible, nonporous nail that allows the remaining natural nail to grow. KeryFlex is composed of a resin material which is applied on the affected nails following the next steps: debridement of the nail, application of bond, application of the resin in the desired color, shape, and size, and curing of the resin by an ultraviolet light. The typical interval between KeryFlex applications is 6 to 8 weeks.

Application of an artificial resin nail to the affected digit may help counter burdensome effects of retronychia or nail lichen planus, including impaired social interactions and loss of functionality. There are no other options for symptom management of retronychia or nail lichen planus in the literature to our knowledge. Attachment of an artificial nail to the newly growing nail may also prevent distal embedding caused by dorsal expansion of the distal pulp, a possible complication of the loss of counterpressure induced by the loss of the nail plate after total nail avulsion.6 Nail resin will be applied as part of the study. Importantly, patients with retronychia very often report that their nail does not grow as quickly as the non-affected ones. Therefore, Keryflex application may be particularly useful if these patients, considering that they would not need to replace the Keryflex as often.

KeryFlex, Pod-Advance, Inc. will provide necessary equipment, but it does not pay Weill Cornell Medicine to conduct this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in social domain of quality of life, as measured by social domain scale

时间窗: Baseline; Week 8

A three-item social domain scale Total possible low score in quality of life, social domain: 0 (0=worst quality of life, social domain) Total possible high score in quality of life, social domain: 100 (100=best quality of life, social domain)

Change in symptoms domain of quality of life, as measured by symptoms domain scale

时间窗: Baseline; Week 8

A three-item symptoms domain scale Total possible low score in quality of life, symptoms domain: 0 (0=worst quality of life, symptoms domain) Total possible high score in quality of life, symptoms domain: 100 (100=best quality of life, symptoms domain)

Change in emotional domain of quality of life, as measured by emotional domain scale

时间窗: Baseline; Week 8

A seven-item emotional domain scale Total possible low score in quality of life, emotional domain: 0 (0=worst quality of life, emotional domain) Total possible high score in quality of life, emotional domain: 100 (100=best quality of life, emotional domain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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