Romans Sur Isere

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool SALT, eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.

Researchers are evaluating the safety and effects of Abrocitinib in adults with moderate to severe atopic dermatitis, a long-lasting skin condition that causes inflammation, redness, and irritation. This observational study aims to understand how Abrocitinib works in real-life clinical settings for patients aged 18 and older who do not have other medical conditions that would prevent them from taking the medication. All participants will take Abrocitinib as a daily tablet and may also use medicated topical treatments for their condition. The study lasts 24 months, during which participants will be monitored regularly. They will visit the study clinic approximately five times, about once every 4 to 6 months, to report their experiences and health status while using the medication. Throughout the study, researchers will assess participants using various measures such as skin condition scores, itching severity scales, and sleep quality assessments. They will also track treatment adherence, any changes in medication dosage, and any side effects. The main outcome focuses on the proportion of patients achieving clear or almost clear skin after 16 weeks, with ongoing evaluations through 24 months to monitor safety and effectiveness.

Researchers are studying atopic dermatitis AD, a long-lasting inflammatory skin condition marked by itchiness and recurring eczema. They aim to assess skin changes in patients treated with tralokinumab, an antibody therapy targeting IL-13 that has shown promise for moderate-to-severe AD. Traditional assessments rely on clinical scores like Eczema Area Severity Index EASI and SCORAD, which can vary between observers. This study uses reflectance confocal microscopy RCM, a noninvasive imaging technique that examines the skin at the cellular level to better understand treatment effects. Participants with moderate-to-severe AD who are starting treatment with tralokinumab will be observed. The study will evaluate skin thickness and other structural changes before treatment begins and at 16 weeks after starting therapy using RCM. This observational study does not involve altering patient treatment but monitors skin changes during standard care with tralokinumab. During the study, participants will undergo RCM imaging to assess skin layers and inflammation. Researchers will measure the thickness of affected skin before treatment and at week 16 to track changes. Patients must provide informed consent and be able to participate for the duration of the study. The total study period extends through November 2028, with ongoing observation of skin responses to therapy.

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.

Researchers are evaluating the use of a low-protein diet LPD with specially designed low-protein foods called FLAVIS in patients with chronic kidney disease CKD stages 3A to 5 who are not on dialysis. The study aims to compare this approach to a standard low-protein diet without these low-protein foods to see if it helps patients better manage their protein intake and potentially improve their quality of life. This trial is randomized and controlled, led by Dr. Schr AG SPA, following the 2020 KDOQI nutrition guidelines for CKD. Participants are randomly assigned to one of two groups one will follow a low-protein diet according to current practice, while the other will follow the same diet but with the addition of FLAVIS low-protein products. The intervention group will receive FLAVIS products to include in their diet. The study tracks dietary adherence, protein intake, and other health measures over a 12-month period. During the study, participants will attend scheduled visits at baseline, 1, 3, 6, 9, and 12 months. Researchers will monitor protein intake, diet compliance, body mass index BMI, weight, body composition, blood and urine markers, diabetic glycemic profiles, patient quality of life, and satisfaction with the diet. Safety will be assessed by tracking adverse events throughout the 12 months. Participants will complete diet records and self-administered questionnaires as part of the data collection process.

Atopic dermatitis AD is a long-lasting inflammatory skin condition characterized by itching and recurring eczematous eruptions. Researchers are studying skin changes in patients with moderate-to-severe AD who are treated with nemolizumab, a humanized anti-IL-31 monoclonal antibody, to better understand how the skin structure changes during treatment. This research uses reflectance confocal microscopy RCM, a noninvasive technique that examines the epidermis and papillary dermis at a cellular level, to evaluate skin structure and inflammation. The study observes patients with moderate-to-severe AD who require systemic treatment with nemolizumab. Nemolizumab is being assessed for its impact on skin changes visible using RCM. The main goal is to measure the thickness of the affected skin at week 16 of treatment. Participants are monitored while receiving nemolizumab as part of their usual care. Participants will have their skin examined using RCM to observe structural and inflammatory changes during treatment. The research team will assess skin thickness at 16 weeks to evaluate treatment response. Eligible adults with moderate-to-severe AD will provide informed consent before joining. The study lasts until 2028, with follow-up assessments scheduled to understand skin modifications over time.

This trial is a rollover study for adults who previously participated in specific Incyte-sponsored clinical trials involving the drug povorcitinib. It focuses on people with Hidradenitis Suppurativa HS, a condition being studied to better understand the long-term safety and effects of continuing povorcitinib treatment. The purpose is to monitor participants who have already benefited from povorcitinib in earlier studies, now entering an extended phase to further evaluate safety and treatment outcomes. Participants will continue taking povorcitinib orally, following the same dose and schedule they had in their original parent study. This study does not test new doses or compare treatments but observes continued use of the drug under the established regimen. The study may last for up to approximately three years, reflecting extended monitoring rather than initial treatment phases. During the study, participants will attend scheduled visits for assessments, including tracking any treatment-emergent adverse events and measuring symptom counts related to HS. Researchers will collect safety data over the long term and observe clinical responses. Participants must adhere to study procedures and avoid pregnancy or fathering children as required. The study aims to provide detailed safety information over an extended period while participants remain on the drug regimen from their original trial.

Researchers are investigating the best approach to treat patients with cutaneous squamous cell carcinoma CSCC who have a high risk of the cancer returning after surgery. This study compares two strategies adding radiation therapy after surgery called adjuvant radiotherapy versus closely monitoring patients without immediate additional treatment. The goal is to see if disease-free survival DFS, which means the time patients remain free from cancer recurrence, differs between these two approaches. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy starting within 8 to 12 weeks after surgery, delivering a total dose of 45 to 50 Gy to the area where the tumor was removed. Radiation may be given externally with high-energy photons or electrons, or through brachytherapy. The other group will undergo regular monitoring without additional treatment after surgery. Both groups will continue follow-up until cancer recurrence or death, with decisions for any further treatment left to the treating physician. Participants will be followed every 4 months for the first 2 years and then every 6 months thereafter. During visits, doctors will perform clinical exams, review any other treatments the patient is receiving, conduct imaging tests, and assess quality of life through questionnaires. The study will track outcomes such as disease-free survival, local and regional recurrence, metastatic recurrence, overall survival, treatment tolerance, and quality of life. Follow-up will continue until death or progression of disease, with assessments up to 36 months for many outcomes.

Plaque psoriasis is a chronic inflammatory disease characterized by thick, red and white scaly patches on the skin. This observational study evaluates the change in quality of life for adults with moderate to severe plaque psoriasis who are treated with risankizumab in real-world clinical settings. The study will enroll about 700 participants worldwide who are prescribed risankizumab according to local medical guidelines. Participants will receive risankizumab as prescribed by their doctors following routine clinical practice and the local label. No additional treatments or procedures are imposed by the study. Participants will be followed for up to 2.5 years to observe their treatment experience and quality of life outcomes. During the study, participants will attend regular visits at hospitals or clinics as part of their usual care. Researchers will measure outcomes such as the Dermatology Life Quality Index score at 12 months to assess the impact of risankizumab on quality of life. The study does not add extra burdens beyond routine clinical visits and will monitor participants until study completion in March 2028.

Researchers are conducting a prospective non-interventional study to better understand the needs and experiences of adolescent and adult patients with atopic dermatitis AD who start or switch any systemic treatment. The study aims to assess patient journeys and evaluate the safety and clinical outcomes of systemic AD treatments in real-world settings across multiple countries and geographical regions. Patient-specific factors such as age, skin color, flare triggers, previous treatment responses, comorbid conditions, and lesion characteristics will be studied to gain a broad understanding of treatment impact. Participants in this observational study will be those who initiate or switch systemic treatments for AD, including biologics, oral Janus kinase JAK inhibitors, cyclosporine, azathioprine, methotrexate, or mycophenolate mofetil, based on country-specific prescribing information and standard of care. Treatments will be prescribed by investigators according to usual medical judgment, without any experimental intervention from the study. This study will follow participants for up to five years to observe treatment patterns and outcomes. During the study, participants will have their treatment utilization, treatment duration, switching, dose modifications, and reasons for changes recorded. Researchers will also measure changes in the severity and extent of AD using tools like the Eczema Area and Severity Index EASI, Body Surface Area BSA, Investigators Global Assessment, and patient-reported outcomes such as itch, skin pain, sleep disturbance, and overall disease control. Other assessments include quality of life, work productivity, comorbid conditions, and adverse events. The study will provide long-term observational data over a period of up to 60 months.