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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Clinical Research Centre (CRS)
Berlin, Germany
Incidence of the Treatment-Emergent Adverse Events (TEAEs) at each dose for dose escalation
Time frame: from baseline until the end of study (9 months)
Incidence of Serious Adverse Events (SAEs) at each dose for dose escalation
Time frame: from baseline until the end of study (9 months)
Incidence of clinically significant Adverse Events (AEs) at each dose for dose escalation
Time frame: 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
Time frame: 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)
Time frame: 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.
ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs at maximum frown and at rest where 0 is "no lines are noticeable" and 3 is "lines are extremely pronounced".
Time frame: Day 29
Response to treatment measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction.
SSA: a validated 4-point categorical scale to assess the appearance of their Glabellar Lines (GLs) at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles".
Time frame: Day 29
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Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the Subject Level of Satisfaction (SLS)
Time frame: From the baseline to the end of the study (9 months)
Duration of treatment response based on ILA and SSA at maximum contraction
Time frame: From the baseline to the end of the study (9 months)
Face-Q (overall satisfaction with facial appearance) for Upper Facial Lines (UFL)
Time frame: Visits screening, Day 1, Day 15, Day 29, 3 months, 6 months, 9 months
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines.
Time frame: From Day 1 through Day 8