NCT02163746已完成不适用
A Prospective, Randomized, Controlled Clinical Trial Comparing the Efficacy Carbon Dioxide (CO2) Laser Excision Versus Surgical Deroofing in the Treatment of Hidradenitis Suppurativa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of Life Measures
研究概览
简要总结
This study compares two well-known treatment options for Stage 2 hidradenitis suppurativa: carbon dioxide (CO2) laser excision versus surgical deroofing.
详细描述
- We will be treating patients with Stage 2 (interconnected sinus tracts and nodules) hidradenitis suppurativa who have somewhat active involvement (including drainage) in the axillae. We will only be treating ONE axilla per patient.
- After patients are screened and deemed appropriate candidates, they will be randomized to a treatment group: CO2 laser excision or surgical deroofing.
- For each patient, there will be a single intervention (either CO2 laser excision or surgical deroofing), after which there will be 5 planned follow-up appointment at following intervals: 1 week, 2 weeks, 4 weeks, 3 months, 6 months. This will take place over course of 6 months for each patient.
- During the study, subjects will be asked to provide information on quality of life measures, and filling out questionnaires (DLQI and Skindex29) at each visit.
- Inclusion criteria:
- Be at least 13 years old and have a diagnosis of hidradenitis affecting the underarms.
- Agree to follow and undergo all study-related procedures, and follow-up over six month period.
- Exclusion criteria:
- Patients who have already undergone surgical excision to affected area.
- Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of CO2 laser in pregnant females, as well as risk of lidocaine use during pregnancy and breastfeeding
- Patients with a history of allergy to lidocaine or topical anesthetics will not be able to take part in this study.
- Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation.
- Patients with a pacemaker/defibrillator in place.
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
- 13 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 13 years old
- •Be otherwise healthy
- •Have a diagnosis of HS
- •Patients must have Hurley Stage II HS affecting the axilla, with one or more widely separated recurrent abscesses, with formation of a sinus tract and/or scarring
- •Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- •Agree to follow and undergo all study-related procedures
- •If applicable, minors must have permission of legal guardian for participation in the study
- •Exclusion criteria:
- •Patients with HS Hurley stage I and III will be excluded from participation
- •Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of CO2 laser in pregnant females, as well as risk of lidocaine use during pregnancy and breastfeeding
- •Any reason the investigator feels the patient should not participate in the study
- •If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial
- •History of allergy to lidocaine or topical anesthetics
- •Patients with a history of vitiligo as the CO2 laser may cause new spots of depigmentation
- •Patients with a pacemaker/defibrillator in place
- •Patients who have previously undergone surgical intervention and recurred in the axilla to be treated
排除标准
- 未提供
结局指标
主要结局
Quality of Life Measures
时间窗: June 2014-February 2014
Quality of Life measures will be measured via DLQI and Skindex29 patient surveys.
次要结局
未报告次要终点
研究者
Iltefat Hamzavi
Senior Staff Physician
Henry Ford Health System
研究点 (2)
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