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Investigator initiated clinical trial of dantrolene as a treatment for Darier disease
EU CTIS ID: 2024-519201-36-00
What this study is testing
To evaluate if dantrolene treatment reduce skin area affected.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 3. Written consent to participate in the study will also be an inclusion criterion as well as age at least 18 years.
You likely can't join if
- 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)
See the full eligibility criteria
- 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 3. Written consent to participate in the study will also be an inclusion criterion as well as age at least 18 years.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.