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Hidradenitis clinical trials

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NCT ID: NCT05927948 Completed - Clinical trials for Hidradenitis Suppurativa

Evaluating the Safety and Efficacy of Laight®-Therapy Treatment in Subjects With Hidradenitis Suppurativa

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

Hidradenitis suppurativa (HS) is a debilitating and chronic condition characterized by recurrent episodes of inflammation associated with the formation of abscesses, inflammatory nodules, pain, and drainage ultimately culminating in the formation of scarring in moderate to severe disease.1 HS affects more women than men in a ratio of approximately 3:1, and onset of the disease is typically after puberty.2 The axillae, breasts, groin, buttocks, and lower abdomen are common intertriginous regions which are affected by HS, and significant impacts on quality of life are reported in the literature.1 The Hurley Staging system is commonly utilized to classify the severity of a patient's hidradenitis suppurativa. Stage 1 disease consists of one or more abscesses with no sinus tract formation or scarring. Stage 2 disease involves one or more widely separated recurrent abscesses, with formation of a sinus tract and/or scarring. Stage 3 involves multiple interconnected sinus tracts and/or abscesses throughout an anatomical area. Histologic studies of HS suggest that follicular hyperkeratosis and obstruction is the primary event in the pathogenesis. Subsequently, there is rupture of the follicular infundibulum and a resulting inflammatory cascade. Despite recurrent episodes of purulent drainage, bacteria do not appear to play a primary role in the pathogenesis.3 The traditional repertoire of treatment options for HS can be divided into medical and surgical options, however there is currently no cure for HS and treatments focus on symptomatic control. Medical treatments including topical and systemic antibiotics, hormonal agents, and biologic medications can successfully control symptoms however discontinuation of many of these is associated with relapses in disease symptoms.4,5 Conversely, surgical interventions such as traditional surgical excision performed in an operating room, or carbon dioxide laser excision performed under local anesthetic in an outpatient setting can induce long term symptom control however may not be appropriate for all patients considering the risk of general anesthesia, high cost of inpatient hospitalizations, and cumbersome healing process for procedures which heal by secondary intention.6 Despite numerous treatment options for HS, efficacious and non-invasive treatment options which result in long term remission of disease are needed to meet the needs of HS patients.

NCT ID: NCT05663268 Completed - Clinical trials for Hidradenitis Suppurativa

Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa

Start date: October 1, 2022
Phase: Early Phase 1
Study type: Interventional

The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are: - how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa - Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy

NCT ID: NCT05635838 Completed - Clinical trials for Hidradenitis Suppurativa

Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Start date: December 7, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.

NCT ID: NCT05355805 Completed - Clinical trials for Hidradenitis Suppurativa

Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS). This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.

NCT ID: NCT05322473 Completed - Clinical trials for Hidradenitis Suppurativa

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Start date: April 25, 2022
Phase: Phase 2
Study type: Interventional

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

NCT ID: NCT05286567 Completed - Clinical trials for Hidradenitis Suppurativa

A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.

Start date: September 1, 2021
Phase: Phase 1
Study type: Interventional

This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy Phase 2 trials. Male or female subjects aged 18 years or older with moderate to severe hidradenitis suppurativa will be included in this study. Objectives are to determine the efficacy and safety of RGRN-305 in patients with moderate to severe hidradenitis supppurativa.

NCT ID: NCT05216224 Completed - Clinical trials for Hidradenitis Suppurativa

ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

Start date: December 29, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).

NCT ID: NCT05194969 Completed - Clinical trials for Hidradenitis Suppurativa

Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

Hidradenitis suppurativa (HS) is a chronic, severe, inflammatory skin disease associated with pain, drainage, odor, and disability characterized by recurring abscesses, nodules, and tunneling sinuses in intertriginous locations such as the groin, buttocks, and axillae. HS has more negative impact on patients' quality of life than all other common dermatologic diseases and is common, affecting ~1% of the general population, with higher risk for females (3:1) and Black patients. The onset is often in adolescence. As HS has been under-studied historically, there is an unmet medical need to develop more effective treatment for this disease. While many patients are managed with medications and lifestyle modifications alone, a subset of HS patients benefit from surgical intervention. Proper wound care following HS surgery is paramount, as facilitating proper healing and minimizing infection can prevent post-operative complications, morbidity and the need for future procedures. While many physicians continue to use wet-to-dry dressings as the standard of care for HS patients post-operatively, it is likely that the drawbacks of this dressing technique outweigh the benefits. This study hopes to answer the question of whether or not wet-to-dry dressings should truly be standard of care or whether an alternate form of wound dressings, such as petrolatum with non-stick bandaging, is at least equitable if not superior in effect, and associated with fewer drawbacks such as associated pain and time dedicated to dressing changes. This study will be a randomized, single-blind trial of two postoperative bandaging techniques: wet-to-dry dressings vs. petrolatum with non-stick bandaging. Primary outcomes will be tracked using the photographic wound assessment tool (PWAT), pressure ulcer scale of healing (PUSH) tool, and Wound Quality of Life (QOL) Survey. There is potential for this study to apply to surgical interventions outside of HS, as the study addresses the bandaging technique (wet-to-dry) that is standard of care after many surgical procedures.

NCT ID: NCT05125458 Completed - Hiv Clinical Trials

Relationships Among Inflammation, Physical and Mental Health in Subjects With Chronic Inflammatory Physical Diseases.

InflaMent
Start date: April 1, 2021
Phase:
Study type: Observational

The prevalence of common mental disorders is high in patients with chronic inflammatory physical diseases(e.g., autoimmune or infectious diseases). The traditional explanatory causation model in which physical symptoms and related disability drive mental health problems is now called into question, and evidence has accumulated supporting more complex interactions whereby psychiatric disorders can both result from and contribute to the progression of physical diseases. In the present project, the investigators will focus on comorbidity of depression and anxiety symptoms or syndromes with chronic inflammatory skin diseases (psoriasis, hidradenitis suppurativa and atopic dermatitis) or chronic infectious diseases (chronic HBV and HIV infection). The study is aimed to clarify the mechanisms underlying the high frequency of those comorbidities. It will overcome the main limitations of previous investigations and use innovative statistical tools to model complex interrelationships and causal links among the assessed variables. The identification of key variables driving the causal chain of determinants of poor global health and quality of life may impact treatment outcome and models of care.

NCT ID: NCT05103423 Completed - Clinical trials for Hidradenitis Suppurativa

Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

Start date: June 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).