View clinical trials related to Hidradenitis Suppurativa.
Filter by:This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
Hidradenitis suppurativa (HS) is a chronic, socially and cosmetically debilitating disease. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. The lesions are often very painful and can chronically drain malodorous fluid, which can leave affected individuals uncomfortable and self-conscious, or even debilitated. Treatment presents significant challenges and frustration to both the patient and the provider. Measures such as topical antibiotic and antiseptic washes are generally thought to be beneficial for the treatment of early stage HS. When this is not efficacious, systemic antibiotics are prescribed. In some patients, disease remains refractory to these treatments and their fistulas and tracts progress to scarring. In some patients, the disease continues to progress. In these patients who fail conservative medical management and minimally invasive procedures, such as deroofing, is the next step in the therapeutic ladder. In deroofing, the skin overlying the sinus tract is cut, exposing the floor of the tract. These wounds are left open to heal by secondary intention. Also with this technique, recurrence is common. In this study, investigators propose the use of cryoinsufflation for management of the sinus tracts in hidradenitis suppurativa. In this technique, local anesthesia will be administered to the tract area with lidocaine hydrochloride 1% or a similar numbing medication. A needle will be mounted on a cryosurgical unit. The needle will be instered into the tracts at one location on one side of the body and liquid nitrogen will be administered. This will result in obliteration of the sinus tract. This intervention may prevent disease progression and ameliorate the need for these patients to surgically intervene on their disease. Overall, this would result in improved cosmesis, decreased pain, and improved patient satisfaction. The objective of this prospective, randomized controlled clinical trial is to compare the efficacy of cryoinsufflation in patients with draining sinus tracts versus deroofing while keeping the patients on the medications that they currently on for hidradenitis suppurativa. In deroofing, the sinus tract is found. Local anesthesia is administered to numb the area of the sinus tract. The sinus tract is probed. Then the skin overlying the sinus tract is cut, exposing the floor of the tract. These wounds are then left open to heal by secondary intention. Patients with one anatomic location having Hurley stage 2 disease with at least one recurrent sinus tract will be included in the study. Cryoinsufflation will be compared to deroofing. Patients will be randomized into either the group receiving cryoinsufflation (Group A) or deroofing (Group B). The distribution of patients will be completely random similar to a coin toss. Patients will remain on all systemic hidradenitis suppurativa medications throughout the entire duration of the study. The primary endpoint of the study will be time to obliteration of the sinus tract and pain tolerance of cryoinsufflation. Secondary endpoints will include cosmesis (identified through patient photography) and patient satisfaction (identified through study surveys) as well as comparison to deroofing. Patients in group A will be treated with cryoinsufflation at up to five study visits. If it is determined that the patient's sinus tract has scarred over, that will be the patient's final study visit and cryoinsufflation will not be performed. Patients in group B will be treated with deroofing at the first visit and will return for 2 future visits at 28 day intervals. At the study visits the investigators will examine the site of intervention, take clinical photographs, measure the tract, ultrasound the tract, the study doctor will perform visual assesments of the area, the interventions (both cryoinsufflation and deroofing) will be timed, and patients will complete the survey questionnaires. If determined to be superior in efficacy, the addition of cryoinsufflation as an adjuvant therapy to hidradenitis suppurativa could influence treatment guidelines in hidradenitis management, leading to an improvement in the quality of care delivered, especially in terms of cosmetic outcomes, prevention of disease progression, and patient satisfaction.
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disorder, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds such as the axilla, inguinal region and gluteal area. The primary event in HS is occlusion of the hair follicle. HS is a notoriously difficult to treat disease, because treatment options are limited and evidence based treatments are scarce. Prevention of diseases is an important topic in medicine. However, current clinical trials in HS are focusing on anti-inflammatory drugs in patients with severe HS, whereas prevention and treatment of patients with more common mild HS is neglected. Laser hair removal therapy is a non-invasive procedure with minimal treatment discomfort for patients. Previous limited studies have suggested positive results in favor of laser hair removal therapy in HS. We therefore hypothesize that hair depilation using laser hair removal therapy may prevent the formation of new lesions and flares of the disease. The objective is to assess the efficacy of laser hair removal therapy in patients with mild to moderate HS.
Hidradenitis Suppurativa (HS) is a chronic disabling inflammatory skin disorder associated with the development of painful and purulent lesions of the folds (armpits, inguinal folds, sub-mammary glands). HS most often develops in adolescence or young adulthood and is characterized by inflammation of the pilo-sebaceous system, of progressive severity (folliculitis, nodule, abscess, fistula). The pathogenesis of HS is still poorly understood: the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggests that the disease could be due to a dysregulated immune response against microbial skin flora. Unconventional lymphocytes (UL), classically considered being at the interface of innate and adaptive immunity, play an important role in immune protection against microbial flora. But UL dysfunction has also been reported in many autoimmune diseases involving various tissues (joints, digestive tract, skin). The uncontrolled and chronic activation of these UL by skin microbiota could therefore play a role in the pathogenesis of HS.
The pathogenesis of HS is still poorly understood: the pilosebaceous tropism and the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggest the involvement of 3 factors that would be intimately linked: the presence of (i) a microbial dysbiosis, (ii) a dysfunction of the pilosebaceous apparatus and (iii) an inappropriate immune response. But how these 3 elements interact with each other remains unestablished, with few studies that have analyzed them from a kinetic point of view. Beyond a possible dysfunction of the pilosebaceous apparatus, we hypothesize a bacterial dysbiosis in connection with abnormalities of autophagy function with secondary development of an inappropriate immune response. Because of its functions of bacterial clearance and activation of local immune response, a defect in the autophagic process may be associated with the development of inflammatory pathologies related to microbial dysbiosis. Crohn's disease (CD), an inflammatory pathology of the gastrointestinal tract associated with intestinal dysbiosis, has been associated with alterations in autophagy, with approximately 50% of patients having single nucleotide polymorphisms (SNPs) associated with autophagy deficiency (Ellinghaus et al., 2013). The epidemiological association of CD/HS, the presence of skin dysbiosis and a chronic inflammatory response during HS, make us suspect a deficit of autophagic function in these patients, in a similar way to what is observed during Crohn's disease. The aim of this study is to analyze the frequency of 100 SNPs, reported to be associated with autophagy deficiency, in a cohort of moderate-to-severe HS patients.
The aim of this study is to find a genetic link or family trait connecting persons with Hidradenitis Suppurativa (HS) to each other. As a result, discover the cause and perhaps treatment for Hidradenitis Suppurativa (HS).
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
The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.