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Pruritus clinical trials

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NCT ID: NCT06446609 Recruiting - Pruritus Clinical Trials

Drug-induced Liver Injury: Itching Study

Start date: June 14, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06446310 Recruiting - Uremic Pruritus Clinical Trials

Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

NCT ID: NCT06435299 Not yet recruiting - Pruritus Clinical Trials

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

CANNABITCH
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT06366659 Not yet recruiting - Clinical trials for Intrahepatic Cholestasis of Pregnancy

Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy

Start date: April 20, 2024
Phase:
Study type: Observational

This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP.

NCT ID: NCT06334679 Recruiting - Burns Clinical Trials

The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not.

NCT ID: NCT06297499 Not yet recruiting - Clinical trials for Pruritus Caused by Drug

Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section

Start date: March 2024
Phase: Phase 1
Study type: Interventional

Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.

NCT ID: NCT06290375 Not yet recruiting - Pruritus Clinical Trials

A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population.

Start date: March 8, 2024
Phase: Phase 2
Study type: Interventional

This is a two- stage study. Stage I is a multicenter, open-label trial;Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled.

NCT ID: NCT06262607 Recruiting - Clinical trials for Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP)

A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica

Start date: January 29, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP).

NCT ID: NCT06243120 Not yet recruiting - Clinical trials for Pruritus Caused by Drug

Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

The study will assess efficacy of intravenous lidocaine 1 mg/kg diluted with 0.9% sodium chloride to a volume of 100 ml to suppress intrathecal fentanyl induced pruritus. This will be compared to control group who will receive 100 ml normal saline as placebo. The main outcome is regression of initial VAS score with incidence of pruritus.

NCT ID: NCT06226610 Not yet recruiting - Pruritis Clinical Trials

Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic

Start date: February 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.