BOTULINUM TOXIN TYPE A for Dystrophic scar | Post-sternotomy scarring

Inclusion criteria

• {"criterion_text":"- Patient aged 18 years old or over\n- Surgery with sternotomy\n- Covered by medical insurance\n- Patient able to attend follow-up visits\n- Patient able to sign informed consent"}

Exclusion criteria

• {"criterion_text":"- Known allergy to botulinum toxin type A or to one of BOTOX®'s excipients (human albumin, sodium chloride)\n- Subclinical or clinical manifestations of abnormal neuromuscular transmission (myasthenia or Lambert-Eaton syndrome)\n- Peripheral motor neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)\n- Treatment with drugs that interfere directly or indirectly with neuromuscular transmission (aminoglycosides, curares, anticholinesterase agents, aminoquinoline, cyclosporine, etc.)\n- History of neuromuscular disorders\n- Injection site infection\n- Previous surgery with general anesthesia (curarization) in the month prior to inclusion\n- Pregnancy or breastfeeding\n- Persons under court protection, guardianship or conservatorship"}

Primary endpoints

• {"endpoint_text":"- Comparison of means of the Stony Brook Scar Evaluation Scale (SBSES) at 6 months (M6) (collected by a dermatology team assessor, blinded to randomization) for each scar half (treated with botulinum toxin injection or placebo).","definition_or_measurement_approach":"SBSES score at 6 months collected by a dermatology team assessor blinded to randomization; comparison of means between scar halves treated with botulinum toxin versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for scar width (mm)","definition_or_measurement_approach":"Scar width measured in mm at months 3, 6, 12 and 18 by a dermatology observer blinded to treatment; comparison of mean values between treated and placebo halves."}
• {"endpoint_text":"- Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for the Patient and Observer Scar Assessment Scale (POSAS): observer scale","definition_or_measurement_approach":"POSAS observer scale scores at months 3, 6, 12 and 18 collected by blinded dermatology observer; comparison of mean scores between treated and placebo halves."}
• {"endpoint_text":"- Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M6, M12 and M18 for the Physician's Global Assesment.","definition_or_measurement_approach":"Physician's Global Assessment scores at months 3, 6, 12 and 18 by blinded dermatology observer; comparison of mean scores between treated and placebo halves."}
• {"endpoint_text":"- Comparison of mean scores collected for each scar half (toxin-treated vs. placebo) by a dermatology team observer blinded to randomization at M3, M12 and M18 for Stony Brook Scar Evaluation Scale","definition_or_measurement_approach":"SBSES scores at months 3, 12 and 18 collected by blinded dermatology observer; comparison of mean SBSES between treated and placebo halves."}

France

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

9

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France