Active clinical trials for "Hidradenitis"

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.

Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.

With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.

The purpose of this study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa

To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic (long lasting) skin disorder that mostly affects the armpits and groin area. It appears as blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus. Scarring may result after several attacks of the disease. The exact cause of HS isn't known. However, it is believed that the plugging of hair follicles and bacterial infection that occur in acne also occur in HS. Many of the medications used for treating acne are also used for HS. However, none of the medications are consistently effective. YAZ is a combination birth control pill. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen) and drospirenone (a progestin). People who develop acne have sebaceous glands that are over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the male sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the condition occurs after puberty. It affects more women than men and HS often gets worse around the time a women has her menstrual period. YAZ has been approved by the U.S. Food and Drug Administration (FDA) to treat moderate acne in women who desire an oral contraceptive for birth control. This study uses a placebo. A placebo looks like the study drug but contains no active drug. We use placebos in research studies to learn if the effects seen in research subjects are truly from the study drug or from other reasons.

The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting. By regularly measuring outcomes longitudinally in patients treated in a real-world setting, this study will provide valuable and necessary information as to the impact of both the disease and its treatments on patients over time and will inform the optimal clinical management of patients with living with dermatological disease.

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.

Hidradenitis Suppurativa is a recurrent chronic inflammatory follicular occlusive disease affecting hair follicles. HS is notoriously difficult and challenging to treat with a high morbidity impact and could be classified as an unmet medical need with no efficient therapeutic options. Objective: Investigators previously showed that Outer Root Sheath Cells (ORS) isolated from hair follicle of HS patients (HS-ORS) have a pro-inflammatory phenotype and secrete spontaneously IP-10 and RANTES. To identify the mechanisms involved in the pro-inflammatory phenotype of HS-ORS, investigators performed a transcriptomic analysis in healthy and HS patients. This revealed: (i) an IFN signature, (i) a dysregulation of genes involved in cell proliferation and differentiation, and (iii) an upregulation of DNA damage response and cell cycle G2/M checkpoint pathways in HS-ORS. These findings support the notion that, in HS patients, a perturbation of HF-SC homeostasis leading to an increased proliferation induces a replicative stress and an accumulation of cytoplasmic ssDNA, stimulating IFN synthesis through IFI16-STING pathway. Interestingly, replicative stress in ORS were present in some but not all patients with Hidradenitis Suppurativa. The goal of study is to determine replicative stress in ORS in a large cohort of HS patients. Method Patients will be enrolled in the Mondor Dermatology department, during routine care. A dermatologist will check all inclusion and exclusion criteria with the technical support of a research technician of the Henri Mondor Clinical Investigation Center. Medical history, clinical data, comorbidities and concomitant therapies will be prospectively recorded in a dedicated case report form. Skin biopsies will be performed in perilesional zone rich in hair follicles. mRNA will be extracted from freshly isolated hair follicle cells and some slides will be prepared and stored at -80°C to perform immunohistochemistry analysis on freshly isolated hair follicle cells. PBMC and serum will be collected. All these biological samples will allow us to quantify the replicative stress in HS-ORS of each patient, and to quantify several cytokine of interest : IFN de type 1, IL-17, IL-6, TNF-α, IL-10 This study will allow investigators to evaluate the rate of patients with replicative stress in hair follicle stem cells in Hidradenitis Suppurativa. The investigator will also determine whether HF-SC replication stress correlates with clinical characteristics and/or with clinical course and/or comorbidities.