Randomized Double Blind Placebo Controlled Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient reported improvement after invention with Botulinum toxin B
研究概览
简要总结
Randomized double blind placebo controlled pilot study/proof of concept-study to see if intradermal injection with Botulinum toxin B is an effective treatment of Hidradenitis suppurativa
详细描述
Twenty patients with hidradenitis suppurativa will be enrolled and randomised to treatment with either botulinum toxin B or placebo (saline) in affected areas.
Intervention and recording of data will be performed every three months. After three months, all patients will receive active substance. After six months, randomization will revealed. Patients with clinical improvement will be given the opportunity to continue treatment for additional six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Partcipant and investigator/outcomes assessor are blinded. Treatment will be given after randomization by a secondary investigator.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active hidradenitis in the stage I-III according to Hurleys classification. Patients are referred to a dermatology out-patient clinic or patients already in an established treatment program, where there is indication for new or different treatment, or surgical intervention. Patients must have typical affection of the disease of either axillae, groins, and/or perigenital/perianal area
排除标准
- •Patients in need of emergency medical or surgical treatment of hidradenitis will be excluded until the disease is in a quiet, controlled phase.
- •Pregnant or lactating, as well as patients with neurological disease such as myasthenia gravis or motor neuron disease.
研究组 & 干预措施
Botulinum B Toxin
Botulinum toxin B (Neurobloc(R)) 50 Units (U)/ml 0,05-0,1 ml/injection intradermally in a grid with 1- 1 1/2 cm between every injection in affected areas A maximum of 4000 U/patient/treatment Treatment every three months
干预措施: Botulinum B Toxin (Drug)
Placebo
Saline (NaCl 0,9%) 0,05-0,1 ml/injection intradermally in a grid With 1- 1 1/2 cm between every injection in affected areas Treatment in placebo group (n=10) only at first intervention
干预措施: Placebo Saline (Other)
结局指标
主要结局
Patient reported improvement after invention with Botulinum toxin B
时间窗: End point analysis 6 months
Outcome measured by Dermatological Life Quality Index (DLQI)-scores
次要结局
- Identification of clinical subgroups with best response to intervention as assessed by patient reported improvement(Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months)
- Identification of clinical subgroups with best response to intervention as assessed by clinically scored measures(Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months)
- Identify if covariates such as age, disease duration, smoking state, BMI and sweating influence patient reported improvement(Interim analysis after 6 weeks- 3 months. End point analysis 6 months and sub group analysis 12 months)
研究者
Øystein Grimstad
Md PhD
University Hospital of North Norway