Ongoing Clinical Trials for Keratosis Follicular
Currently, there is 1 ongoing clinical trial investigating new treatment options for keratosis follicular, also known as Darier disease. This trial is testing whether dantrolene sodium, a medication typically used for muscle spasms, can help reduce the skin area affected by this rare genetic skin disorder. The trial is being conducted in Sweden and is expected to continue until 2026.
Clinical trial locations
Study on Dantrolene Sodium for Treating Darier Disease in Affected Patients
This clinical trial is investigating whether dantrolene sodium can provide relief for people living with Darier disease, a rare genetic skin condition characterized by rough bumps and red patches on the skin. The medication is taken orally in capsule form.
Who can participate?
To join this study, participants must meet specific criteria:
- Have a confirmed diagnosis of Darier disease, either through a skin sample examination called histopathology, or have typical skin symptoms such as small rough bumps and skin redness along with a family history of the disease
- Have a Physician Global Assessment score of at least 3, indicating a certain level of disease severity
- Be at least 18 years old
- Provide written consent after understanding what participation involves
- Both men and women can participate
Who cannot participate?
The study excludes:
- People who do not meet the age requirement
- Individuals who do not have Darier disease
- People who belong to vulnerable populations that might need special protection or care
What is the trial investigating?
The main goal of this trial is to determine whether dantrolene sodium can reduce the area of skin affected by Darier disease. Researchers will use a 5-point Physician Global Assessment scale to measure changes, with a 20% reduction considered meaningful. The study will also examine whether the treatment improves quality of life related to skin health, mood, and overall satisfaction with the medication. Additionally, researchers will monitor the skin using other assessment tools and carefully track any side effects or reactions to the medication.
The investigational drug
Dantrolene sodium is the medication being tested in this trial. While it is typically used to treat muscle spasms, researchers are exploring whether it can help with Darier disease. The medication works at the cellular level by interfering with calcium release in cells, which helps relax muscles and may also benefit skin cells. In this study, participants will take Dantrium Capsules containing 25mg of dantrolene sodium. The trial is expected to run until June 2026.
Summary
Currently, only one clinical trial is actively recruiting patients with Darier disease. This trial, located in Sweden, represents an important step in exploring new treatment options for this rare genetic skin condition. The use of dantrolene sodium, a medication already approved for other conditions, demonstrates a repurposing approach that may offer hope to patients who have limited treatment options. The trial’s comprehensive assessment approach, including quality of life and mood measurements alongside physical skin evaluations, reflects a patient-centered focus on overall wellbeing rather than just physical symptoms.