Ongoing Clinical Trials for Ichthyosis
Currently, there are 2 ongoing clinical trials investigating new treatments for ichthyosis. These studies are testing different medications to help improve symptoms such as dry, scaly skin, redness, and itching. Both trials are being conducted in France and focus on specific genetic forms of the condition.
Clinical trial locations
- France
Study on the Effects of Deucravacitinib for Adults with Inflammatory Skin Conditions (Epidermolysis Bullosa Simplex and Congenital Ichthyoses)
This trial is investigating whether a medication called deucravacitinib can help adults with inflammatory congenital ichthyoses. The study also includes patients with epidermolysis bullosa simplex, another inflammatory skin condition.
Who can participate: You may be eligible if you are over 18 years old and have a confirmed laboratory diagnosis of one of the following conditions: congenital ichthyosiform erythroderma, keratinopathic ichthyosis caused by mutations in the KRT1 or KRT10 genes, or epidermolysis bullosa simplex caused by mutations in the KRT5 or KRT14 genes. Both men and women can participate.
Who cannot participate: The study excludes people who do not have these specific skin conditions, those outside the adult age range, and individuals considered part of a vulnerable population who might need special protection or care.
What the trial involves: The main goal is to evaluate how effective and safe deucravacitinib is for treating these inflammatory skin conditions. Participants will take deucravacitinib as a 6 mg tablet by mouth. The study lasts 44 weeks and follows a specific pattern where the medication is given, then stopped, and then given again. This approach helps researchers understand how the medication works over time.
Throughout the study, researchers will assess how the medication affects the severity of your skin condition, the level of itching and pain you experience, and your overall quality of life. Safety will be closely monitored, and researchers will analyze certain proteins in the body to understand their role in these conditions.
The medication being tested: Deucravacitinib is a selective tyrosine kinase 2 inhibitor that works by blocking specific enzymes involved in inflammation, potentially reducing symptoms. It is taken orally and is currently in the clinical trial phase to determine its benefits and risks for inflammatory skin disorders.
Study on the Effects of Injectable Gentamicin for Patients with Moderate to Severe Congenital Ichthyosis
This clinical trial is testing whether gentamicin, a medication typically used to treat infections, can help improve skin symptoms in people with moderate to severe congenital ichthyosis caused by a specific type of genetic change known as a nonsense mutation.
Who can participate: You may be eligible if you are 18 years or older and have hereditary ichthyosis caused by a mutation in one of the following genes: TGM1, PNPLA1, ALOX12B, NIPAL4, ALOXE3, SDR9C7, ABCA12, CERS3, SPINK5, or CDSN. Your condition must be moderate to severe, determined by a VIIS score between 2 and 3 in at least two areas such as the back, upper limbs, lower limbs, or back of the foot. You must also agree to participate by providing informed consent.
What the trial involves: The study aims to evaluate how effective gentamicin injections are in reducing the severity of skin scales and redness over time. Participants will receive gentamicin injections and will be monitored at regular intervals throughout the study. Researchers will track changes in skin condition severity, assess itching levels, and evaluate overall quality of life.
Various assessments will be conducted to ensure participant safety, including checks of kidney function, hearing, and balance. At month 3, a small skin sample will be taken from the inner arm to evaluate protein expression. The study includes monthly evaluations for up to 9 months, with regular monitoring for any side effects.
The medication being tested: Gentamicin is an aminoglycoside antibiotic administered through injections. While it is primarily known for treating bacterial infections, this Phase 2 trial is investigating whether it can help reduce skin scaling and redness in patients with congenital ichthyosis caused by specific genetic mutations. The medication works by disrupting protein synthesis.
Summary
Both ongoing clinical trials for ichthyosis are currently being conducted in France, providing opportunities for patients in this region to access potential new treatments. The trials take different approaches: one focuses on an oral medication that targets inflammation, while the other tests an injectable antibiotic for its potential to improve skin symptoms in patients with specific genetic mutations.
These studies represent important research efforts to find new treatment options for people living with various forms of congenital ichthyosis. The trials are designed to carefully monitor both the potential benefits and safety of these medications over extended periods, ranging from several months to nearly a year. If you have congenital ichthyosis and meet the specific criteria for either trial, speaking with your healthcare provider about participation may be worthwhile.