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临床试验/NCT03054155
NCT03054155已完成不适用

Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Wayne State University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5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
30
试验地点
2
主要终点
HS-LASI

研究概览

简要总结

Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.

详细描述

Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows:

Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2

A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.

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

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65
  • Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement.

排除标准

  • Pregnant patients or patients planning to get pregnant during the time of the study
  • Patients on systemic treatment for Hidradenitis Suppurativa
  • Patients with photosensitivity disorders
  • Patients unable to tolerate the laser treatments
  • Intake of a photosensitive medication

结局指标

主要结局

HS-LASI

时间窗: Monthly for 4 months, then once 2 months later(6 months total)

Change in Hidradenitis Suppurativa Lesion, Area, and Severity Index Score from baseline

次要结局

  • HiSCR(Monthly for 4 months, then once 2 months later(6 months total))

研究者

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

Steven D Daveluy

Medical Doctor

Wayne State University

研究点 (2)

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