Stopped: Sponsor terminated the study due to strategic considerations
The purpose of the protocol, is to assess the safety and efficacy profile of IPN59011 compared to a placebo. IPN59011 is expected to work longer than product already marketed in the treatment of subjects with moderate to severe facial wrinkles.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation
Timeframe: from baseline until the end of study (9 months)
Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation
Timeframe: from baseline until the end of study (9 months)
Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation
Timeframe: from baseline until the end of study (9 months)
Incidence of AEs (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) for dose escalation
Timeframe: from baseline until the end of study (9 months)
Presence of botulinum neurotoxin serotype A (BoNT-A) antibodies and IPN59011 antibodies and titres (binding and neutralizing)
Timeframe: from baseline until the end of study (9 months)
Response to treatment measured by the composite response of 2-grade improvement on investigator's live assessment (ILA) at maximum contraction.
Timeframe: Day 29
Response to treatment measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction.
Timeframe: Day 29