A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- HS Physician Local Improvement Assessment - PAIN
研究概览
简要总结
This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.
详细描述
The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects are at least 18 years of age or older
- •A confirmed diagnosis of HS disease
- •Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts
排除标准
- •Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.
- •Are participating in another study using an investigational agent or procedure during participation in this study.
- •Are currently pregnant or planning to get pregnant during the study.
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
研究组 & 干预措施
Hypertonic Saline
23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.
干预措施: 23.4% Hypertonic saline (Drug)
结局指标
主要结局
HS Physician Local Improvement Assessment - PAIN
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Fluid Leakage From Fistula
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Erythema
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Tenderness
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Swelling
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Hardness of Skin
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Hotness of Skin
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
HS Physician Local Improvement Assessment - Odor
时间窗: Baseline and Visit 4 (week 8)
Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from 'extremely worse' to 'very much improved'. Physicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.
次要结局
- HS Patient Local Improvement Assessment - Hotness of Skin(Baseline and Visit 4 (week 8))
- HS Patient Local Improvement Assessment - Odor(Baseline and Visit 4 (week 8))
- HS Patient Local Improvement Assessment - Tenderness(Baseline and Visit 4 (week 8))
- HS Patient Local Improvement Assessment - Swelling(Baseline and Visit 4 (week 8))
- HS Patient Local Improvement Assessment - Hardness of Skin(Baseline and Visit 4 (week 8))
- Numeric Rating Scale for Stinging(Baseline and visit 4 (week 8))
- Numeric Rating Scale for Pain(Baseline and visit 4 (week 8))
- Length of Fistula(Baseline and visit 4 (week 8))
- HS Patient Local Improvement Assessment - Fluid From Fistula(Baseline and Visit 4 (week 8))
- HS Patient Local Improvement Assessment - Erythema(Baseline and Visit 4 (week 8))
- Dermatology Life Quality Index(Baseline and visit 4 (week 8))
- HS Patient Local Improvement Assessment - Pain(Baseline to Visit 4 (week 8))
研究者
Martina Porter
Instructor in Dermatology
Beth Israel Deaconess Medical Center