Lichen Sclerosus

Researchers are evaluating the effectiveness of delgocitinib cream applied twice daily compared to a cream vehicle for treating adults with mild to severe lichen sclerosus LS, a skin condition affecting mostly 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 includes both female and male participants to further assess the chosen dose and safety in males. Participants receive different dosing regimens of delgocitinib cream or cream vehicle applied twice daily during a 12-week initial treatment period, followed by a 40-week continuation treatment period. Different groups receive varying doses or sequences of delgocitinib cream and cream vehicle to compare effects. A substudy evaluates male participants separately to assess safety and efficacy. During the trial lasting between 55 and 60 weeks, participants undergo regular assessments including clinical evaluations of LS severity using IGA-LS scores, pain and itch numerical rating scales, and quality of life indexes. Safety is monitored through adverse event tracking and laboratory tests. The main outcome measured is the number of participants achieving a specific improvement in LS severity at Week 12, with additional evaluations continuing through Week 52.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

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 interventions 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 as a treatment for two types of scarring hair loss conditions Central Centrifugal Cicatricial Alopecia CCCA and Frontal Fibrosing Alopecia FFA. This open-label, phase 2 clinical trial will include about 20 adults diagnosed with moderate-to-severe forms of these conditions. The study is conducted by the Icahn School of Medicine at Mount Sinai and aims to assess changes in various inflammatory and fibrotic markers in the scalp over time. Participants will receive deucravacitinib orally at a dose of 12 mg once daily for 48 weeks. The study groups consist of individuals diagnosed with either CCCA or FFA. Treatment begins at the baseline visit Day 0 and continues daily without a placebo comparison. The full treatment period lasts 48 weeks, during which participants will be monitored for biological and clinical changes related to their hair loss. Throughout the study, participants will attend scheduled visits to evaluate changes in immune and fibrotic markers in the scalp at weeks 24 and 48. Clinical assessments will include hair loss severity scores, quality of life indexes, itch severity scales, and hair density and thickness measurements. Safety and adherence will be monitored through medical histories, physical exams, and laboratory tests. The total commitment for participants is approximately 48 weeks of treatment and follow-up assessments.

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.

Researchers are evaluating the safety and effectiveness of the Cutera 1726 nm laser system, also known as AviClear, for treating facial papules in people with frontal fibrosing alopecia FFA. This study focuses on measuring changes in the size and appearance of these papules to better understand this treatment approach. Participants will receive three laser treatments spaced about four weeks apart. After the treatment sessions, they will be followed for approximately 12 weeks. The study lasts about 30 weeks in total, during which participants will attend up to five visits to receive treatments and assessments. Throughout the study, researchers will measure changes in papule size using dermatoscopy and ultrasound, count lesions through physical exams, and assess lesion depth with optical coherence tomography or ultrasound. Standardized photographs and physician global assessments will also evaluate changes. A blinded dermatologist will review data after completion. Participants will be monitored closely during this period to evaluate treatment effects and safety.