The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient. Participants will: * Take drug every day for up to 52 weeks * Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable). * Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of AEs, TEAEs, ADRs, SAEs
Timeframe: From enrollment to the end of treatment at 52 weeks
Frequency of discontinuation of treatment due to TEAEs
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of systolic blood pressure during the study
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of diastolic blood pressure during the study
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of heart rate during the study
Timeframe: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (height)
Timeframe: From enrollment to the end of treatment at 52 weeks
Change from baseline of local tolerability- Application site signs/symptoms during the study
Timeframe: From enrollment to the end of treatment at 52 weeks
Assessment of overall application site irritation over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (weight)
Timeframe: From enrollment to the end of treatment at 52 weeks
Physical examination during the study (BMI)
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of RBC over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of WBC over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Haematocrit over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Haemoglobin over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCV over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCH over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of MCHC over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Platelets over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of neutrophils over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Lymphocytes over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Monocytes over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Eosinophils over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Basophils over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline of Differential blood count over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in AST (GOT) over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in ALT (GPT) over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Triglycerides over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Total cholesterol over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in HDL-C (high-density lipoprotein cholesterol) over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in LDL-C (low-density lipoprotein cholesterol) over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Plasma glucose over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in HbA1c (glycated haemoglobin) over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in Insulinemia over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks
Changes from baseline in beta-HCG over the study duration
Timeframe: From enrollment to the end of treatment at 52 weeks