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Ongoing Clinical Trials Related to Skin Disorders

This article provides information about 8 ongoing clinical trials investigating treatments for various skin-related conditions, including autoimmune diseases affecting the skin, bacterial infections, and chronic inflammatory conditions. The trials are being conducted across multiple European countries and are testing different medications, from antibiotics to immunomodulatory drugs and bio-engineered skin substitutes.

Clinical trial locations

Study of Hydroxychloroquine Safety and Effectiveness in Patients with Early Systemic Sclerosis

This trial is being conducted in Italy and focuses on testing hydroxychloroquine as an additional treatment for people with early-stage systemic sclerosis, a rare autoimmune disease that causes hardening of the skin and internal organs.

Main inclusion criteria: Participants must be adults aged 18 or older who have been diagnosed with systemic sclerosis according to specific medical criteria. The disease must have been present for 5 years or less from the first symptom that is not related to Raynaud’s phenomenon. Patients must be on stable treatment for at least 4 weeks before starting the study and must either have never taken hydroxychloroquine or stopped taking it at least 16 weeks before joining.

Main exclusion criteria: People under 18 or over 65 years old cannot participate. Those with known allergies to hydroxychloroquine, pregnancy or breastfeeding, significant heart problems, severe kidney or liver disease, eye problems affecting the retina, uncontrolled diabetes, active infections, history of seizures, or those currently participating in other clinical trials are excluded.

Focus and goals: The study will evaluate whether adding hydroxychloroquine to standard treatments helps reduce symptoms in early systemic sclerosis. The medication will be taken daily for 52 weeks, with the dose calculated based on body weight (up to 400 mg per day). Doctors will monitor various aspects including skin changes, blood vessel function, pain levels, morning stiffness, and fatigue throughout the year-long study period.

Investigational drug: Hydroxychloroquine is a medication commonly used for malaria and autoimmune conditions. It works by reducing inflammation and modifying immune system function. The trial also involves continuing standard therapies including immunosuppressive medications and vasoactive medications that improve blood flow.

Study of single-dose oritavancin safety and tolerability in children with acute bacterial skin and skin structure infections

This trial is taking place in Lithuania, Romania, Bulgaria, Portugal, Latvia, Greece, Poland, and Spain. It examines the use of oritavancin in treating serious bacterial skin infections in children.

Main inclusion criteria: Children aged between 3 months and 12 years old with diagnosed skin infections such as wound infections, cellulitis, erysipelas, or major skin abscesses. The infection must show at least two signs like pus drainage, redness, swelling, warmth, or pain, plus at least one sign of body-wide infection such as swollen lymph nodes, fever, low temperature, or abnormal blood test results.

Main exclusion criteria: Children younger than 3 months, those with known allergies to oritavancin or similar antibiotics, active heart valve infections, severe kidney or liver problems, bone or joint infections, suspected bloodstream infections, recent use of other antibiotics, or those unable to comply with study procedures cannot participate.

Focus and goals: The study aims to determine if oritavancin is safe and well-tolerated by children. Participants will receive a single dose through intravenous infusion, and doctors will monitor how well the infection heals and track any side effects. Follow-up visits will assess the recovery progress over a period that may last up to 14 days.

Investigational drug: Oritavancin (also known as ORBACTIV and KIMYRSA) is an antibiotic given through an IV infusion. It is special because it only needs to be given once as a single dose, unlike many antibiotics that require multiple doses.

Study on Long-Term Safety and Efficacy of Litifilimab for Adults with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy

This study is being conducted across Slovakia, Portugal, Italy, Sweden, France, Spain, Hungary, Poland, Germany, and Bulgaria. It focuses on evaluating litifilimab for adults with lupus-related skin conditions.

Main inclusion criteria: Participants must have completed a previous study involving litifilimab and attended their last assessment at week 52. They must be able to understand the study purpose and provide informed consent. The study is open to both male and female participants.

Main exclusion criteria: Patients with active uncontrolled infections, serious allergic reactions to similar medications, unstable autoimmune diseases, current use of interfering treatments, pregnancy or breastfeeding, substance abuse history, uncontrolled severe mental health conditions, or recent participation in other clinical trials cannot join.

Focus and goals: The trial evaluates the long-term safety and effectiveness of litifilimab (BIIB059) over up to 128 weeks. Participants receive the medication as injections under the skin, with regular monitoring to assess symptom improvements using measures like the Cutaneous Lupus Erythematosus Disease Area and Severity Index.

Investigational drug: BIIB059 (litifilimab) is being studied for its potential to help people with certain types of lupus affecting the skin. It is particularly aimed at people who have not had success with traditional antimalarial treatments.

Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis

This trial is being conducted in Bulgaria, Czechia, Spain, Poland, Portugal, and Italy. It assesses the long-term safety of secukinumab for patients with various inflammatory conditions.

Main inclusion criteria: Participants must have completed treatment in a previous Novartis study involving secukinumab. They must be benefiting from the treatment, and the study doctor must believe that continuing is more beneficial than risky. Participants must not have access to secukinumab through local prescription or reimbursement. Both adults and children can participate, with appropriate consent procedures.

Main exclusion criteria: Patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, or juvenile idiopathic arthritis cannot participate according to the exclusion criteria provided.

Focus and goals: The study focuses on long-term safety monitoring of secukinumab over up to 104 weeks. Participants receive the medication through subcutaneous injections, and researchers observe for any adverse events or injection site reactions. The study aims to ensure that patients who benefit from secukinumab can continue to receive it safely.

Investigational drug: Secukinumab is a biologic medication targeting interleukin-17A, which plays a role in inflammation. It is administered as an injection under the skin and is used to help reduce inflammation and improve symptoms in patients with various inflammatory conditions.

Study on Metreleptin for Children Under 6 with Generalized Lipodystrophy and Related Diabetes or High Triglycerides

This trial is taking place in France, Italy, Germany, and Belgium. It studies metreleptin for young children with generalized lipodystrophy, a rare condition affecting fat storage.

Main inclusion criteria: Children younger than 6 years old who have never been treated with metreleptin before. They must have a confirmed diagnosis of generalized lipodystrophy through genetic testing, imaging tests, or clinical diagnosis supported by low leptin levels and signs of insulin resistance. Children must have high blood sugar levels or high triglyceride levels and be on stable treatment plans for at least 90 days (for diabetes) or 6 weeks (for high triglycerides).

Main exclusion criteria: Patients not diagnosed with generalized lipodystrophy, those 6 years or older, or those without associated diabetes or high triglyceride levels cannot participate.

Focus and goals: The study evaluates how effective and safe metreleptin is for managing symptoms over 12 months. Researchers will monitor changes in blood sugar levels and fat levels in the blood. Participants receive metreleptin as injections under the skin, with regular follow-up visits to assess health status and any side effects.

Investigational drug: Metreleptin works by replacing leptin, a hormone usually low in people with generalized lipodystrophy. It helps control blood sugar levels and reduce fat levels in the blood, aiming to improve overall health.

Study on the Effectiveness and Safety of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

This trial is being conducted in France, Germany, Czechia, Romania, Spain, Hungary, Greece, Belgium, Poland, and Austria. It examines remibrutinib for adults with moderate to severe hidradenitis suppurativa.

Main inclusion criteria: Participants must be 18 years or older with a diagnosis of hidradenitis suppurativa for at least 6 months. They must have moderate to severe disease, meaning at least 5 abscesses or inflammatory nodules affecting at least 2 different areas of the body.

Main exclusion criteria: Patients with other interfering skin conditions, recent infections requiring antibiotics, history of cancer (except certain treated skin cancers), heart problems, liver or kidney disease, current use of interfering medications, pregnancy or breastfeeding, recent participation in other trials, or known allergies to the study medication are excluded.

Focus and goals: The study compares remibrutinib to placebo over 68 weeks, evaluating whether it can reduce the number of painful lumps and abscesses. The main goal is to achieve at least a 50% reduction in symptoms by week 16. Additional medications like clindamycin and triamcinolone may be used to help manage symptoms.

Investigational drug: Remibrutinib is a medication taken as a tablet that targets specific inflammatory pathways. It is classified as a Bruton’s tyrosine kinase inhibitor, working to reduce inflammation and symptoms associated with hidradenitis suppurativa.

Study on the Effects of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

This trial is taking place in Germany, Slovakia, Bulgaria, Spain, Italy, Poland, Portugal, Greece, and Denmark. It is another study examining remibrutinib for hidradenitis suppurativa.

Main inclusion criteria: Adults aged 18 or older with hidradenitis suppurativa diagnosed for at least 6 months. They must have moderate to severe disease with at least 5 abscesses or inflammatory nodules affecting at least 2 different body areas.

Main exclusion criteria: Similar to the previous remibrutinib trial, patients with other skin conditions, recent infections, cancer history, heart/liver/kidney disease, pregnancy, breastfeeding, recent trial participation, or medication allergies are excluded.

Focus and goals: This 68-week study aims to achieve at least a 50% reduction in abscesses and nodules by week 16 without worsening other symptoms. The study includes regular assessments to monitor condition improvements and side effects. Additional treatments like triamcinolone, salicylic acid, and clindamycin may be used alongside remibrutinib.

Investigational drug: Remibrutinib is an oral tablet that works by interfering with inflammatory signaling pathways. It targets specific proteins involved in the inflammatory process to help reduce symptoms.

Study on the Safety and Effectiveness of EHSG-KF for Treating Full-Thickness Skin Defects in Adults and Children

This trial is being conducted in Italy and the Netherlands. It tests a new bio-engineered skin graft for treating deep skin wounds.

Main inclusion criteria: Patients must be at least 1 year old with large full-thickness skin defects requiring coverage after removal of scars, non-cancerous skin growths, skin moles, or tissue damage from injury or infection. Minimum coverage areas vary by age: 9 cm² for ages 1-5, 25 cm² for ages 6-16, and 45 cm² for those over 16.

Main exclusion criteria: Patients with infections at the defect site, autoimmune diseases, pregnancy, breastfeeding, active cancer, recent trial participation, allergies to treatment materials, blood clotting disorders, or severe organ diseases cannot participate.

Focus and goals: The study compares EHSG-KF (a bio-engineered skin substitute made from the patient’s own cells) to traditional split-thickness skin grafts. Healing quality is monitored using tools like the POSAS questionnaire over follow-up periods of up to one year. The study aims to determine if EHSG-KF offers better outcomes for healing deep skin wounds.

Investigational drug: EHSG-KF is an autologous bio-engineered skin substitute created from the patient’s own keratinocytes and fibroblasts embedded in a collagen hydrogel. It is designed to improve scar quality and promote natural healing. Traditional STSG involves taking thin skin layers from another body part to cover the wound.

Summary

These 8 clinical trials cover a diverse range of skin-related conditions, from autoimmune diseases to bacterial infections and chronic inflammatory conditions. Several notable patterns emerge from this overview.

Geographically, trials are concentrated in Western and Central European countries, with Germany, Italy, Spain, and Poland appearing most frequently as trial locations. This concentration may reflect the strength of clinical research infrastructure and regulatory frameworks in these regions.

Two trials focus specifically on remibrutinib for hidradenitis suppurativa, conducted across multiple countries, indicating strong research interest in this treatment approach for a challenging chronic skin condition. Both trials share similar designs, comparing remibrutinib to placebo over 68 weeks with goals of achieving at least 50% symptom reduction.

Several trials address rare conditions such as generalized lipodystrophy and systemic sclerosis, highlighting the ongoing need for treatment options for patients with uncommon diseases. Other studies focus on long-term safety monitoring of established medications like secukinumab and litifilimab, ensuring continued patient safety beyond initial approval studies.

The trials span a wide age range, from infants as young as 3 months to adults, demonstrating the broad impact of skin disorders across different life stages. Some studies, such as the EHSG-KF trial, include both children and adults, reflecting the universal need for effective treatments for severe skin defects.

Overall, these trials represent important steps forward in understanding and treating various skin conditions, offering hope for improved outcomes for patients dealing with challenging dermatological issues.

Ongoing Clinical Trials on Skin disorder

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