2024-519201-36-00招募中2 期
Investigator initiated clinical trial of dantrolene as a treatment for Darier disease
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference.
研究概览
简要总结
To evaluate if dantrolene treatment reduce skin area affected.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria will be histopathologically verified diagnosis combined with typical skin symptoms of hyperkeratotic papules and erythema (1), or clinical symptoms combined with family history in which the relative has a histopathologically verified diagnosis (2). Specifically, we will only include patients with a Physician Global Assessment of at least
- •Written consent to participate in the study will also be an inclusion criterion as well as age at least 18 years.
排除标准
- •Liver disease including steatosis, cirrhosis and hepatitis B/C (contraindication)
- •Heart failure
- •Pulmonary disease such as COPD (but not common asthma)
- •Abnormal blood chemistry (assessed by blood samples)
- •Known or suspected allergies against dantrolene or vehicle
- •Systemic treatment for Dariers disease that cannot be paused during the study (e.g. acitretin)
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •Participation or recent participation in a clinical study with an investigational product (within 30 days).
- •Concomitant Medication that may interact (taken at least bi-weekly for medications taken on a daily basis or at all for depo medications): antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine), antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone), apalutamide, benzodiazepines (e.g., alprazolam, diazepam, lorazepam), bosentan, brimonidine, buspirone, calcium channel blockers (e.g., amlodipine, diltiazem, verapamil), cannabis, chloral hydrate, dabrafenib, dexamethasone, efavirenz, enzalutamide, etravirine, methadone, mirtazapine, mitotane, modafinil, muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine), nabilone, narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone), pramipexole, rifabutin, rifampin, ropinirole, rotigotine, St. John's wort, scopolamine, seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide), selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline), siltuximab, sodium oxybate, tapentadol, thalidomide, tocilizumab, tramadol, tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine), zolpidem, zopiclone
- •Wheat allergy (contraindication)
- •Hypersensitivity to the active substance or to any filling material (contraindication)
- •Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (contraindication)
- •Whenever spasticity is utilized to obtain or maintain increased function (contraindication)
- •Pregnancy, breastfeeding, or planned pregnancy.
- •Recent acute illness (past 4 weeks)
- •Active substance abuse
- •Kidney disease
结局指标
主要结局
The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference.
The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference.
次要结局
- As the main secondary endpoint, improvement in dermatological quality of life index (DLQI) will be used. A 4 points improvement in DLQI will be considered the minimal clinically important difference (24). We will also examine mood with the Montgomery–Åsberg Depression Rating Scale (MADRS) and treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM).
- As complementary skin assessment tools we will use the Eczema Area and Severity Index (EASI) scale and Body Surface Area (BSA).
- Number of adverse events and adverse reactions, serious and non-serious.
研究者
Dr Jakob Wikström
Scientific
Karolinska University Hospital
研究点 (1)
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