Study on Dantrolene Sodium for Treating Darier Disease in Affected Patients

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	08.06.2022

Trial locations

Investigated drugs:

Dantrolene Sodium

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.

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.

Trial ID:

2024-519201-36-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dantrolene Sodium for Treating Darier Disease in Affected Patients

What is this study about?

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