跳至主要内容
临床试验/NCT04388163
NCT04388163撤回2 期

Effects of Gentian Violet Treatment on Patients With Hidradenitis Suppurativa

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
撤回
入组人数
16
试验地点
1
主要终点
Skin's Redness

研究概览

简要总结

This is a survey study being conducted to describe how subjects with Hidradenitis suppurativa (HS) respond to treatment with gentian violet. The study will rely primarily on qualitative survey responses and quantitative changes in skin appearance.

详细描述

Hidradenitis suppurativa (HS) is a chronic disease of the folliculopilosebaceous unit, often found in intertriginous areas of the body. The pain and impairment of HS leads patients to report a decreased quality of life, even in comparison to other debilitating cutaneous disease states. Pharmalogic management of HS can vary from topical antibiotics or intralesional corticosteroids for mild cases to immunosuppressants and biologic agents in refractory cases. Gentian violet is a topical antiseptic used to treat many cutaneous yeast infections. It also has a role in improving wound healing in sites of active ulceration. It is our hypothesis that gentian violet will help minimize skin trauma in sites of active HS to promote improved wound healing and quality of life.

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must have active HS, be willing to undergo one application of HS, and agree to follow-up in one month.

排除标准

  • Exclusion criteria include children, absent HS lesions at the time of clinic, and cognitive/physical impairments that would make them unable to assess quality of life factors of the survey.

研究组 & 干预措施

Gentian Violet Treatment

Experimental

A single application of gentian violet will be topically applied to the site(s) of active HS involvement by a trained staff member. The sites will then be bandaged by staff and patients will be instructed about home maintenance procedures.

干预措施: Gentian Violet (Drug)

结局指标

主要结局

Skin's Redness

时间窗: 1 month post-treatment

Subjects rate skin redness at treatment site on a scale from 1 (no redness) to 5 (severe redness)

Skin's Drainage

时间窗: 1 month post-treatment

Subjects rate skin drainage at treatment site on a scale from 1 (no drainage) to 5 (severe drainage)

Skin's Pain

时间窗: 1 month post-treatment

Subjects rate skin pain at treatment site on a scale from 1 (no pain) to 5 (severe pain)

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)

Loading locations...

相似试验