Gradignan

Researchers are studying moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI) to compare the effects of oral isotretinoin against the current standard treatment on acne-related pigmentation (ARP). ARP affects about 65% of these patients and impacts quality of life by causing discoloration. The study aims to see if isotretinoin, usually prescribed only after antibiotics fail, is better as a first-line treatment for ARP severity after six months. This is a Phase 3, multicenter, randomized controlled trial involving 420 subjects. Participants will receive either oral isotretinoin starting at 0.5 mg/kg daily (adjusted based on tolerance and response, with a total cumulative dose target of 120 to 150 mg/kg) or a topical cream (retinoic acid or adapalene) combined with oral antibiotics (doxycycline or lymecycline) for the first three months. After three months, the effectiveness will be checked; if acne improves, antibiotics stop but topical treatment continues. If acne remains moderate or severe, isotretinoin may be started. The study compares these approaches over six months. During the study, participants will be monitored for acne severity and pigmentation changes. They must have a cell phone capable of taking high-quality selfie pictures for monitoring. Safety tests include blood work for liver function and lipids. Women of childbearing potential will have pregnancy tests and require effective contraception. Researchers will assess the severity of acne-related pigmentation at six months as the primary outcome. The study will last six months with close follow-up and clinical evaluations to track treatment response and safety.

End-stage renal disease (ESRD) affects many people in France, with nearly 170 new cases per million inhabitants each year and about 92,500 patients undergoing dialysis or kidney transplantation. The treatment for chronic renal failure is costly and patients on dialysis often experience poor health-related quality of life (HRQoL), with severe symptoms that are not always properly addressed. This study evaluates whether regular symptom monitoring and feedback to dialysis patients and their care teams can improve their quality of life over an 18-month period. The trial is a large, multi-center, randomized controlled study nested within a national dialysis patient registry in France. Patients in the experimental group will have their symptoms measured monthly using the IPOS-Renal questionnaire, with severe or overwhelming symptoms automatically reported to healthcare staff. Additionally, their quality of life will be assessed every six months through validated questionnaires over 18 months. Half of the dialysis units will have support from a clinical research nurse for patient inclusion and follow-up during the first 12 months, transitioning to local healthcare teams thereafter. The control group will receive usual care without systematic symptom monitoring but will also complete quality of life assessments every six months. Participants will be monitored through regular questionnaires assessing symptoms and HRQoL, with data collected and analyzed by clinical research teams and social science experts. The study includes a qualitative process evaluation involving interviews with patients and healthcare professionals to understand factors affecting implementation. Outcomes focus on health-related quality of life measured by the physical health score of the KDQoL-36 questionnaire over 12 months. Data on treatment practices and healthcare resource use will also be studied for cost-effectiveness. The total participation lasts 18 months, with ongoing safety and process monitoring.