Not recruitingRare disease

Study on Dantrolene Sodium for Treating Darier Disease in Affected Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called dantrolene sodium on a skin condition known as Darier disease. Darier disease is a genetic disorder that affects the skin, leading to the development of rough bumps and red patches. The medication being tested, dantrolene sodium, is provided in the form of capsules and is taken orally. The purpose of the study is to determine if dantrolene sodium can reduce the area of skin affected by Darier disease.

Participants in the study will take dantrolene sodium over a period of time, and researchers will monitor changes in their skin condition. The main goal is to see if there is a reduction in the affected skin area. Additionally, the study will look at improvements in the quality of life related to skin health and assess mood and satisfaction with the treatment. The study will also keep track of any side effects or reactions to the medication.

The trial is expected to run until 2026, and it aims to provide valuable information on whether dantrolene sodium can be an effective treatment for those living with Darier disease. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the medication's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed through a diagnosis of Darier disease. This includes either a verified diagnosis with typical skin symptoms or clinical symptoms with a family history of the disease.
Participants must be at least 18 years old and provide written consent to participate.
Step 2
Medication administration
The treatment involves taking Dantrium Capsules 25mg, which contain the active substance dantrolene sodium.
The medication is administered orally in the form of hard capsules.
Step 3
Treatment duration
The trial is expected to continue until June 8, 2026. The specific duration of medication administration for each participant will be determined by the study protocol.
Step 4
Primary assessment
The main goal is to evaluate the reduction in the skin area affected by Darier disease using the 5-point Physician Global Assessment (PGA) scale.
A reduction of 20% (1 point) on this scale is considered the minimal clinically important difference.
Step 5
Secondary assessments
Secondary assessments include improvement in the Dermatological Quality of Life Index (DLQI), with a 4-point improvement being significant.
Mood is evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), and treatment satisfaction is measured with the Treatment Satisfaction Questionnaire for Medication (TSQM).
Additional skin assessments are conducted using the Eczema Area and Severity Index (EASI) scale and Body Surface Area (BSA).
The number of adverse events and reactions, both serious and non-serious, are monitored.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of **Darier disease**. This can be done through a special test called **histopathology**, which examines a small sample of skin under a microscope.
The patient should have typical skin symptoms, such as **hyperkeratotic papules** (small, rough bumps on the skin) and **erythema** (redness of the skin).
If the patient does not have a confirmed diagnosis, they can still participate if they have typical symptoms and a family history of the disease, where a relative has a confirmed diagnosis.
The patient must have a **Physician Global Assessment** score of at least 3. This is a way doctors rate the severity of the skin condition.
The patient must be at least 18 years old.
The patient must provide written consent to participate in the study, meaning they agree to join the trial after understanding what it involves.
Both male and female patients can participate in the study.

Who cannot join the trial?

3 criteria

Individuals who are not within the specified age range for the study.
Individuals who do not have the specific medical condition being studied, which is **Darier disease**.
Individuals who are part of a vulnerable population, meaning groups that might need special protection or care.

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Verified sites

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Karolinska University Hospital
Verified
Solna, Sweden

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Investigated drugs

Dantrolene is being studied as a treatment for Darier disease. This medication is typically used to treat muscle spasms, but in this trial, researchers are investigating whether it can help reduce the skin area affected by Darier disease.

Dantrolene Sodium

What is already known about the treatment

Dantrolene – Dantrolene is administered orally in the form of capsules. It is currently being investigated in clinical trials as a potential treatment for Darier disease, a rare skin disorder. The main therapeutic indication for dantrolene in this context is to reduce the skin area affected by the disease. At the molecular level, dantrolene works by interfering with calcium release from the sarcoplasmic reticulum in muscle cells, which helps to relax muscles and may have beneficial effects on skin cells. It is classified pharmacologically as a muscle relaxant.

Investigated diseases

Darier disease – Darier disease is a rare genetic skin disorder characterized by wart-like blemishes on the body. These blemishes often appear as greasy, scaly patches that can be yellow-brown in color. The condition typically begins in adolescence and can vary in severity. It is caused by a mutation in a gene responsible for skin cell adhesion and integrity. The affected areas are usually found on the scalp, forehead, upper arms, chest, back, knees, and elbows. The disease can also lead to nail abnormalities and mucous membrane involvement.