Investigator initiated clinical trial of dantrolene as a treatment for Darier disease
This study is looking at a medicine called dantrolene (brand name Dantrium) to treat Darier disease, a condition that affects the skin. Doctors want to see if taking 25mg capsules of dantrolene can help make the affected skin areas smaller and improve how participants feel about their skin and their overall life. It's a phase II study, meaning researchers are exploring if it works and is safe. They will check how much the skin improves using a doctor's assessment and also look at how it affects daily life, mood, and how satisfied people are with the treatment. The study is open to both men and women aged 18 and older.
At a glance
What is this study about?
This research study is focused on finding new ways to treat Darier disease, a genetic skin condition. The specific medicine being tested is called dantrolene, which is already used for other medical conditions but hasn't been widely studied for Darier disease. Researchers are hoping to find out if this medicine can help reduce the areas of skin affected by the condition.
The main goal of the study is to see if dantrolene can visibly improve your skin. Doctors will use a special scale to judge if the patches of affected skin get smaller. They believe that even a small improvement, like a 20% reduction, could make a meaningful difference to patients.
Beyond just looking at the skin, the study also wants to understand how the treatment affects your daily life. They'll ask about your quality of life, your mood, and how you feel about the treatment overall. This helps them get a complete picture of whether the medicine is truly beneficial for people living with Darier disease. They'll also carefully track any side effects to make sure the treatment is safe.
Key takeaways
- This study is testing a known medicine (Dantrium/dantrolene) for Darier disease.
- The main goal is to see if it can reduce affected skin and improve quality of life.
- It's a Phase II study, exploring effectiveness and safety.
- Open to adults aged 18 and over, both men and women.
- Participation involves taking capsules and attending regular assessments.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
The researchers are specifically looking for people who have Darier disease and want to explore a new potential treatment. It's important that participants are able to understand and follow the study instructions.
There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet the age and sex criteria. These details would be discussed with you by the study team.
- Are you 18 years old or older?
- Do you have Darier disease?
- Are you willing to take capsules as part of the study?
- Are you able to attend regular check-ups and complete questionnaires?
- Do you understand that this is a research study for a new use of a medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would be taking 25mg capsules of Dantrium (dantrolene). This is an investigational drug for Darier disease, meaning it's being studied for this use. Throughout the study, you'll have regular check-ups where doctors will assess your skin using a special scale. You'll also be asked to fill out questionnaires about how your skin condition affects your daily life, your mood, and how satisfied you are with the treatment. The study team will also monitor you closely for any unwanted side effects. The total length of your participation would be explained by the study team.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is Darier disease?
Darier disease is a genetic skin condition that causes rough, wart-like bumps and patches on the skin, often in oily areas.
What is dantrolene?
Dantrolene is a medicine that's used for some muscle conditions, and in this study, it's being tested to see if it can help with Darier disease.
What does 'Phase II' mean for a study?
A Phase II study means researchers are exploring if a treatment works and is safe for a specific condition, after initial safety tests have been done.
Will I know if the medicine is helping my skin?
Yes, doctors will regularly assess your skin and you'll complete questionnaires about how you feel, so you'll have an idea of any changes.
Do I have to pay to be in the study?
No, you should not have to pay for the study medication or study-related visits. Any other costs would be explained upfront.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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