Clinical Research Directory

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A. For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale \[WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.

Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

Rationale: * People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy. * Difelikefalin is a medicine that can treat the itching related to long term kidney disease. * Clinical studies have shown difelikefalin to reduce itching in adults on haemodialysis, while being safe and tolerable. * The current study is being done in adolescents aged 12 to 17 years on haemodialysis who have moderate to severe itching related to long term kidney disease to assess if difelikefalin is safe in this age group. The aims of the study are: Main aim: To assess the safety of difelikefalin in adolescents who are on haemodialysis and have itching related to long term kidney disease Secondary aim: To measure the amount of difelikefalin that enters the blood in adolescents who are on haemodialysis and have itching related to long term kidney disease Study Design At least 18 adolescents, aged 12 to 17 years, who are on haemodialysis and have itching related to long term kidney disease will take part in this study. All study participants will receive difelikefalin 3 (or up to 4) times weekly for up to 12 weeks. The study duration for a participant is up to 17 to 18 weeks; during this period, participants will visit the clinic 3 times weekly (during their haemodialysis visits).

VR-PMR for Post-Burn Symptoms

The goal of this clinical trial is to learn whether progressive muscle relaxation (PMR), delivered either alone or enhanced with virtual reality (VR), can help treat chronic symptom, such as pain, itch, anxiety, sleep disturbances, and fatigue, in adult burn survivors. The main questions it aims to answer are: * Does VR-enhanced PMR (VR-PMR) reduce chronic pain, anxiety, itch, sleep disturbances, and fatigue more effectively than standard PMR? * Is VR-PMR a feasible and acceptable self-administered home-based intervention for burn survivors? Researchers will compare two self-administered intervention conditions, VR-enhanced PMR and standard PMR, using a randomized to sequence crossover design to see if VR technology enhances the therapeutic effects of PMR on chronic symptom management in burn survivors. Participants will: * Complete home-based sessions of VR-enhanced PMR * Complete home-based sessions of standard PMR * Report symptoms such as pain, itch, anxiety, sleep disturbances, and fatigue throughout the study * Use VR equipment provided for the intervention period (during the VR-PMR arm)

Assessing the Efficacy and Safety of Photobiomodulation for the Treatment of Pruritus

This study is designed to evaluate the safety and effectiveness of a low-level near-infrared LED light device for relieving itch. The device is non-invasive, does not break the skin, and does not produce heat. Near-infrared light has been used in other medical settings and is known to interact with skin and nerve pathways. In this study, researchers are examining whether this light can be safely applied to the skin and whether it may help reduce itch by affecting signals involved in itch sensation.

Methotrexate Versus Apremilast for Pruritus in Psoriasis

This randomized controlled trial aims to compare the efficacy of Methotrexate versus Apremilast in reducing pruritus and improving quality of life in patients with psoriasis. Eighty patients aged 20 to 60 years with psoriasis involving more than 8% body surface area and associated pruritus will be enrolled and randomly assigned into two groups. Group A will receive oral Apremilast titrated to 30 mg twice daily, while Group B will receive oral Methotrexate 10 mg once weekly for 8 weeks. The primary outcome will be change in Dermatology Life Quality Index (DLQI) score at 8 weeks. Secondary outcomes include change in numerical rating scale for pruritus and assessment of adverse effects. The study will be conducted at Pakistan Emirates Military Hospital Rawalpindi.

Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch

The purpose of this study is to determine if cervical traction is an effective treatment to reduce GABAergic medication use for scalp, arm, and upper back neuropathic itch.

TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.

Drug-induced Liver Injury: Itching Study

Idiosyncratic drug-induced liver injury (DILI) is an unpredictable adverse hepatic reaction to a medication used in its therapeutic dose. DILI is the second most common cause of itching in adult Hepatology after biliary obstruction. In particular cholestatic or mixed pattern types of DILI (in which bile flow from the liver is impaired) are associated with long-lasting effects as well as reduced quality of life. There is therefore an urgent need to determine the incidence and natural history of itching in DILI and establish a network of centres that will form a basis for a clinical trial to investigate a novel intervention to treat these.

A Clinical Study to Assess the Safety and Effectiveness of Utixira Lotion and Utixira Tablet in Healthy Adult Human Subjects With Dry or Sensitive Skin Prone to Mild to Moderate Pruritus and Urticaria

This exploratory, prospective, open-label, single-centre, safety, efficacy and in-use tolerability study of the Utixira Lotion + Utixira Lotion as regimen in healthy adult human subjects with dry or sensitive skin and prone to mild to moderate pruritus or urticaria

Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus in Solid Cancer Patients

Pruritus, commonly known as itching, is an unpleasant sensation that triggers the urge to scratch, which may provide temporary relief. Pruritus can be intermittent or persistent, localized or widespread, and may be associated with medication use. Chronic pruritus, defined as lasting more than six weeks, can significantly affect sleep and quality of life. Dermatologic toxicities are among the most common immune-related adverse events (irAEs), reported in 43-45% of patients receiving ipilimumab and approximately 34% of those treated with nivolumab or pembrolizumab. Combination therapies (ipilimumab+ nivolumab or pembrolizumab) tend to elevate the incidence of potential irAEs to 41%. These toxicities typically emerge within the first few weeks of treatment, though delayed-onset cases have been documented. Cutaneous irAEs occur more rapidly in patients receiving combination therapy compared to anti-PD1 monotherapy. Pruritus is one of the most frequently observed cutaneous irAEs. Current treatments for pruritus are often inadequate, leaving many patients suffering from persistent and debilitating symptoms. Despite available therapies, a significant number of individuals continue to experience chronic itch that negatively impacts their quality of life. Substance P (SP) functions as a neurotransmitter and neuromodulator in the central and peripheral nervous systems of mammals. It is produced by both neuronal and non-neuronal cells and plays a role in various physiological responses, including nausea, depression, vomiting, pain, neurogenic inflammation, and, more recently, pruritus. SP exerts its biological effects primarily through neurokinin receptors (NKRs), also known as tachykinin receptors. When SP binds to NK1R in the skin, it triggers mast cell degranulation, leading to the release of pruritogenic and proinflammatory mediators such as histamine, interferon-γ, leukotriene B4, vascular endothelial growth factor (VEGF), and nerve growth factor (NGF). This results in vasodilation and neurogenic inflammation, manifesting clinically as pruritus, erythema, and edema. NK1R antagonists are a class of drugs with antiemetic, antidepressant, anxiolytic, and antipruritic properties, though they have not been effective as analgesics in humans. These drugs act centrally by crossing the blood-brain barrier and selectively blocking NK1R activation by SP in the central nervous system, particularly in vomiting centers. Aprepitant has also demonstrated efficacy in treating pruritus induced by anticancer therapies. This study is a pilot, single-center open label study evaluating the safety and efficacy of single course of EMEND® (aprepitant) capsules (80mg +125mg) in treating pruritus (new onset and/or refractory) induced by immune checkpoint inhibitors in patients with solid tumors.

Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus

The product RL3020-DP0364 developed by Pierre Fabre Laboratories moisturizes durably and repairs dry or atopic skin, especially in the case of certain dermatoses (atopic dermatitis, ichthyosis, etc ...) and erythema induced by radiotherapy. Its unique formula treats the symptoms of dry skin by creating a protective film that prevents dehydration and helps protect the skin from external aggressions. Through this study, the efficacy of this medical device will be evaluated specifically in subjects presenting stable psoriasis, dry skin and pruritus with an application on the whole body (excluding the head).

Reducing Itch With Hypnosis and Virtual Reality

Chronic itch is a disabling condition with currently limited treatment options. Virtual reality (VR) is a relatively new approach that provides immersion in another environment and has been shown to have a temporary itch mitigating potential. Hypnosis, which is a state of relaxation, has been successfully applied with more long-term treatment effects in the specific case of itch as a result of severe atopic dermatitis. However, hypnosis tends to depend on an individual's susceptibility, or ease, to come into a hypnotic state. A combination of VR and hypnosis (VRH) has been put forward since it may combine the longer lasting effects of hypnosis with VR making the hypnosis more accessible by facilitating imagination. Even though VRH is a promising avenue, it has never been investigated in the context of itch. In this randomized controlled trial, comparing a VRH treatment with a waiting list control group after 6 sessions and at follow-up, it is aimed to assess the effectiveness of VRH in reducing itch along with its psychological burden in adult individuals with therapy-resistant disabling itch.

Efficacy and Tolerance of Cannabidiol in Patients with Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study

Pruritus is defined as an unpleasant sensation leading to the need to scratch. Medications for pruritus are much less effective than those used for pain and it is imperative to find new therapeutic options. Over the last 20 years, the understanding of the pathophysiology of pruritus has progressed significantly, opening new possible therapeutic fields. Among these, cannabinoids seem very promising because the physiological inhibitory role of endocannabinoids, mainly produced by neurons, has been well demonstrated. Data from the literature suggest that the antipruritic effects of cannabinoids are due to a combination of effects on neuronal activation, transmission along the afferent pathway, and local modulation of keratinocytes and mast cells. The antipruritic effect is peripheral and central, through modulation of CB1, CB2 or TRPV1 channels. CB1 and CB2 receptors are specific cannabinoid receptors, CB1 being present at the central and peripheral level while CB2 is only peripheral and very present in the skin. Cannabinoids can also bind to TRPV1, and thus inhibit neurogenic inflammation by antagonizing or stabilizing this ion channel, which prevents neuronal activation by pruritogenic mediators. Phytocannabinoids are derived from cannabis and are used for a variety of purposes, with their development for medical purposes expanding rapidly. The two best known are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC binds to TRPV1, CB2 and CB1, the activation of the latter being at the origin of parallel psychotropic effects. CBD binds mainly to TRPV1, which allows us to expect very favorable effects on pruritus, neurogenic inflammation and skin pain, without fearing side effects of this type. A limited number of studies suggest that cannabinoids may be useful topically or systemically, in humans or animals, but no comparative study with placebo has been performed. These encouraging results have been observed in cases of induced pruritus, idiopathic pruritus, eczema, uremic pruritus, cholestatic pruritus, prurigo, sensitive skin or even epidermolysis bullosa. Currently, the ANSM is conducting an evaluation of the effects of medical cannabis on severe pain. We propose to evaluate the effects on severe pruritus in a randomized placebo-controlled study one of the products chosen by the ANSM in this context, the oil LITTLE GREEN PHARMA, which we choose for its dominant CBD ratio (THC \< 5 mg/ml, CBD \> 5 mg/ml).

Swiss Itch Registry

This project is to develop a national registry for CP patients. Patients admitted to this registry will be examined and documented with PROs, physician-based assessments, blood tests, 3D photodocumentation and, if indicated, by skin biopsies, neurophysiological testing and radiological imaging at defined timepoints. The data collection will allow deepened insights into patient needs, different mechanisms and courses of pruritic conditions, treatment outcomes and treatment-related safety issues. In addition, the collection of clinical, biological and image-based data may be used for retrospective analyses.

Meditation in Inflammatory Dermatosis

Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. The objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.

The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis

Atopic dermatitis is a common disease affecting millions worldwide. A common associated symptom in this population is pruritus. We seek to investigate the use of an natural, over-the-counter cosmeceutical to help this population

Establishment of a Patient Library in Patients With Pruritus Sine Materia

Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.