Lichen Sclerosus

Researchers are evaluating the effectiveness of delgocitinib cream applied twice daily compared to a non-active cream (cream vehicle) in treating adults with mild to severe lichen sclerosus (LS), a skin condition mainly affecting females in the anogenital area. The study is conducted in two parts: Part 1 enrolls female participants to determine the best dose, and Part 2 will include both females and males to further assess efficacy and safety, including a substudy for males. This is a phase 3, double-blinded, vehicle-controlled trial led by LEO Pharma. Participants will be randomly assigned to receive different doses of delgocitinib cream (20 mg/g or 8 mg/g) or cream vehicle, applied twice daily during an initial 12-week treatment period. This is followed by a 40-week continuation period where participants may continue with the same treatment or switch between delgocitinib cream and cream vehicle depending on their assigned group. The trial includes multiple treatment arms to compare the effects of the cream at selected doses and vehicle over these periods. During the trial, participants will attend clinic visits for assessments of skin condition severity, pain, itch, and quality of life using specific scales such as IGA-LS, CLISSCO, Skin Pain Numerical Rating Scale, and Vulvar Quality of Life Index. Safety will be monitored through reports of adverse events and clinical evaluations. The total participation time for each individual ranges from 55 to 60 weeks, including both treatment periods and follow-up assessments.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

Researchers are evaluating noninvasive imaging methods to study the appearance of skin and mucosal lesions to improve diagnostic accuracy before a biopsy is needed and to help guide treatment planning. This study involves creating an Image Repository to store these images for clinical practice, teaching, training, and future research. It uses a high-resolution Optical Coherence Tomography (OCT) device called ApolloVueae S100 Image System that provides detailed cross-sectional and en-face images with cellular information. Participants with muco-cutaneous lesions, including normal skin, benign lesions, or neoplastic conditions, identified during routine clinical care will undergo various non-invasive imaging tests. These include dermoscopic imaging, 3-dimensional total body photography, confocal microscopy, OCT imaging, ultrasound, hyperspectral imaging, electrical impedance spectroscopy, and patient self-imaging using mobile phone technology with dermatoscope attachments. Images will be collected of untreated and treated lesions over a period of 7 years. Participants will have their lesions imaged using these non-invasive tools, with images collected and stored in the Image Repository. Assessments include capturing detailed images using specialized devices to evaluate lesion morphology, depth, vascular features, and biochemical information. Researchers will monitor the imaging data to support clinical decisions, teaching, and future research. Participation may involve multiple imaging sessions over time, and safety monitoring includes ensuring no allergic reactions to imaging materials. The study welcomes healthy volunteers and all ages, with informed consent or parental consent and patient assent as applicable.

Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the intervention's impact.

Researchers are studying the management of Genitourinary Syndrome of Menopause (GSM), a condition causing symptoms like vaginal atrophy that affects quality of life in postmenopausal women. This trial aims to assess the safety and effects of a new hormone-free gel called XCMIM20m applied topically to the vulvovaginal area. The study uses a patient-reported outcome measure called the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire to compare symptoms before and after treatment. Participants will apply 2 ml of the XCMIM20m gel daily, divided into two 1 ml doses taken about 12 hours apart, preferably morning and bedtime, for 8 weeks. The gel is manually applied to the vulvar area, including the vaginal opening, without an intravaginal applicator. Adverse effects like irritation or infections will be monitored and recorded throughout the study. Women will self-assess their symptoms using the DIVA questionnaire at the start and end of the 8-week treatment to evaluate changes in GSM symptoms and quality of life. Researchers will track any side effects and collect detailed information if any occur. The primary measurement is the change in symptom impact on quality of life after 8 weeks of using the gel, with additional focus on the most affected quality of life areas.

Researchers are evaluating the effect of laser maintenance therapy compared to the standard maintenance treatment with clobetasol propionate in female patients with vulvar lichen sclerosus, a chronic inflammatory skin disorder that can cause scarring, sexual dysfunction, and risk of malignancy. This trial aims to compare the effectiveness and duration of benefits of fractional CO2-laser treatment against topical corticosteroid maintenance therapy. Participants receive either three monthly sessions of fractional laser treatment using the Monalisa Glide device along with daily drug-free skin care, or maintenance treatment with topical clobetasol applied twice weekly, also combined with daily drug-free skin care. The clobetasol group receives instruction at trial start and monthly checks to monitor treatment adherence. During the study, participants will undergo assessments including the Lichen Score at 3 months as the primary outcome, and follow-up measures at 15 months such as the Lichen Score, Vulva Assessment Scale, and German Pelvic Floor Questionnaire. The trial is randomized and single-blinded, with ongoing monitoring of treatment effects over the study period. Participation involves regular visits for treatment and evaluations to track skin condition and quality of life.

Researchers are investigating the best ways to detect recurrence in women with vulva cancer. This Danish nationwide multicenter study aims to improve treatment and follow-up programs by combining patient-reported outcomes with clinical data. The team also plans to explore if circulating tumor-DNA (ctDNA) can be found in blood samples, which may help identify early signs of cancer returning. The study includes 295 patients in the clinical group and compares results to a historical control group of 1,000 patients diagnosed between 2011 and 2022. All participants will undergo regular collection of patient-reported outcome measures every four months during their surveillance period, along with liquid biopsies to measure ctDNA at baseline and throughout follow-up. Based on patient responses, nurse telephone interviews will be conducted using an algorithm to guide care. The historical control group data will be obtained from the Danish Gynecological Cancer Database for comparison. The study is non-randomized and open-label. Participants will be followed for up to two years or until cancer recurrence. Data collected will include symptom reports, ctDNA levels, and procedural actions taken during their care pathway. The study will assess recurrence-free survival and overall survival over two years, along with quality of life and symptom management. This comprehensive monitoring aims to detect relapse early and improve management of late effects from treatment.

Researchers are evaluating deucravacitinib in adults with two types of scarring hair loss: Central Centrifugal Cicatricial Alopecia (CCCA) and Frontal Fibrosing Alopecia (FFA). This phase 2, open-label study involves about 20 participants to assess the effects of this treatment over 48 weeks. The study is conducted at the Icahn School of Medicine at Mount Sinai and aims to understand changes in specific biological markers in affected scalp areas. All participants receive deucravacitinib orally at a dose of 12 mg once daily for 48 weeks, starting from the baseline visit. There are two groups based on diagnosis: one with CCCA and one with FFA. The treatment phase lasts for the full 48 weeks with no placebo or comparison group, allowing researchers to monitor the treatment's impact over time. Participants will be involved in regular study visits to assess changes in various immune and fibrotic markers in scalp tissue from baseline through week 48. Researchers will also measure clinical outcomes like hair loss severity, quality of life, itch severity, and hair count characteristics. Safety and adherence are monitored throughout, and the primary results focus on changes in inflammatory and fibrotic markers by week 24, with further assessments up to week 48.

Researchers are evaluating treatments for vulvar lichen sclerosus in women of reproductive age. This prospective, randomized study compares the effects of combined dynamic quadripolar radiofrequency (DQRF) therapy plus topical high-potency corticosteroids with topical corticosteroid therapy alone. The study aims to assess clinical outcomes, patient-reported symptoms, and tissue-level changes in vulvar skin using histology and immunohistochemistry. Safety will be monitored throughout the study period. Participants will be randomly assigned to one of two groups. One group will receive topical corticosteroid therapy following a standardized regimen, followed by four sessions of DQRF therapy every two weeks starting two weeks after corticosteroid initiation. The other group will receive only the topical corticosteroid treatment. Tissue biopsies will be taken from a subset of participants before treatment and three months after treatment completion to analyze estrogen and androgen receptor expression, elastin fibers, and superoxide dismutase 2 (SOD2) levels. During the study, participants will have regular clinical assessments at baseline, end of treatment, and at 3, 6, and 12 months after treatment completion. These visits include vulvar examinations, documentation of skin changes and symptoms, and patient questionnaires on itching, pain, burning, dryness, sexual function, and quality of life. Safety and adverse events related to treatments will be tracked throughout. The main outcome measured is the change in clinical severity of vulvar lichen sclerosus over time, alongside patient-reported outcomes and tissue biomarker changes.

This clinical trial studies fractional ablative laser treatment for women with Lichen Sclerosus lesions. It aims to evaluate the safety and effectiveness of a 2940 nm fractional laser device in treating these lesions. The study focuses on women aged 18 years or older who have biopsy-proven vulvar lichen sclerosus and symptoms such as dryness, itching, burning, bleeding, blistering, soreness, bruising, tearing, ulcerated lesions, or painful intercourse. Participants are randomly assigned to one of two groups: one receiving the fractional 2940 nm laser treatment combined with platelet-rich plasma (PRP), and the other receiving the laser treatment alone. The treatments are delivered using the fractional laser device, and the study compares these two approaches to assess their effects. The study does not mention specific dosing schedules but involves follow-up visits and assessments. Throughout the study, participants will undergo various evaluations including clinical photographs and ultrasound imaging of the treatment area. Researchers will measure histological clearance of the lesions at 16 weeks as the primary outcome. Participants must be able to follow the treatment and follow-up schedule and provide informed consent. Safety monitoring includes exclusion of participants with infections or conditions that may affect wound healing, and pregnancy testing before enrollment. The study duration extends to at least 16 weeks for primary outcome assessment.