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临床试验/NCT04823845
NCT04823845撤回早期 1 期

Plantar Wart Treatment Using Adapalene Gel

University of Louisville0 个研究点开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
撤回
主要终点
Time Until Plantar Wart Resolution

研究概览

简要总结

This study seeks to research the efficacy of Adapalene 0.1% gel as a cost effective and low risk treatment option for plantar warts of the foot. Patients that present/diagnosed in designated clinics with plantar warts will be offered the option of being treated with regular superficial debridements of the epidermis and twice a day application of adapalene gel 0.1% under occlusion. Patients will be followed until resolution.

详细描述

PROBLEM/BACKGROUND: Plantar warts are the result of a DNA virus called Human Papilloma Virus (HPV), specifically subtypes 1,2,4,27, and 57. Plantar warts are a common complaint among adults and children when standing, walking or running as they are on the weight-bearing surface of the foot. These cutaneous infections often occur when walking barefoot at public pools, sidewalks, bathhouses etc. and the epidermis becomes compromised. Surfaces carrying HPV is transmitted and infects the keratinocyte in the compromised skin and begins hyperplasia in the granular, prickle layers, and the dermal papillae. Histologically cell nuclei are eccentrically seen surrounded by koilocytes (halos). This manifests as a hyperkeratotic cutaneous lesion that is a dermal outpouching with break in normal skin lines, painful with lateral or direct pressure, and pin point bleeding. These lesions are often self limiting and resolve in time. However, patients often complain of pain and seek treatments.

Patients often try over the counter remedies with no avail, and then seek professional help for the issue. The standard of care for clinicians is often to use debridement with some form of keratolytic topical agent, such as: salicylic acid, canthridin is used; or cryotherapy, laser (pulse dye or CO2), bleomycin or candida injections are commonly used. Surgical excision is often utilized as well. These treatments are often invasive, painful, and require multiple sessions over a long period of time. Research has suggested the use of adapalene gel 0.1% as a less invasive and faster therapy for plantar warts. The purpose of this study is to test a United States population with Adapalene Gel 0.1% for plantar warts as a viable treatment option with the goals of being faster and less invasive.

OBJECTIVES: Test United States population in the treatment of plantar warts using adapalene gel 0.1%. Measure the amount of time until resolution of the plantar wart using this treatment. Document patient pain with this treatment method.

STUDY DESIGN: Clinician Interventional Prospective Study. Goal of minimum 50 patients will be studied from ages 5-90 years old of all health statuses, race, and genders. Pregnant women will be excluded due to very minimal, but medicine recommendations and guidelines. Patients presenting to outpatient clinics with plantar warts will be treated with a debridement with scalpel down to dermis followed by application of Adapalene 0.1% gel under occlusion. Patients will apply this twice a day under occlusion and return for repeat debridements every 2 weeks. Warts will be measured initially and before and after each debridement until resolution. Patient pain will be assessed each visit and documented.

SUBJECT RECRUITMENT: Patients will present to outpatient clinics, and if diagnosed with a plantar wart will be offered the standard of care treatment at that clinic or the Adapalene gel study treatment if they have not tried any other therapies for 2 weeks. Patients will have the option for the standard of care at the clinic or choose the treatment option of this study. Pregnant women will be excluded. Any patient having received another treatment therapy in the last 2 weeks will be excluded.

研究设计

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

盲法说明

patient information will be kept secure and no individual identifiers will be used.

入排标准

年龄范围
6 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients must be diagnosed with plantar warts

排除标准

  • pregnant women
  • previous wart treatment within the last 2 weeks

研究组 & 干预措施

Plantar Wart Treatment Using Adapalene Gel 0.1%

Experimental

patients treated for plantar warts with Adapalene 0.1% gel

干预措施: Topical Adapalene Gel 0.1% (Drug)

结局指标

主要结局

Time Until Plantar Wart Resolution

时间窗: 30-60 days

days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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