The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines. This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants. Stage 1 (phase Ib \& II) * Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL) * Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport * Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of IPN10200. In the OL phase, participants may receive repeat administrations of IPN10200 for up to three additional cycles (up to four treatment cycles in total during the study). Stage 2 (phase II) - An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL) Stage 3 (phase II) \- A safety and efficacy evaluation of IPN10200 in all three regions (GL, FHL and LCL)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
727
Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
Single administration of study intervention in stage 1 / step 2 and 3 only
MEDITI - Clinique Del Mar
Antibes, France
RECRUITINGAimed S.A.S
Lyon, France
RECRUITINGClinique de Chirurgie Esthétique Iéna
Paris, France
RECRUITINGCRS Clinical Research Services Berlin GMBH
Berlin, Germany
COMPLETEDInterdisciplinary Study Association
Berlin, Germany
ACTIVE_NOT_RECRUITINGROSENPARK RESEARCH GmbH
Darmstadt, Germany
RECRUITINGPrivatpraxis Dr. Hilton & Partner
Düsseldorf, Germany
RECRUITINGFachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Hamburg, Germany
RECRUITINGDermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Mahlow, Germany
RECRUITINGIncidence of treatment emergent adverse events (TEAEs) at each dose
At Stage 1/Step 1, Stage 3
Time frame: From the baseline to the end of the study (9 months)
Incidence of serious adverse events (SAEs) at each dose
At Stage 1/Step 1, Stage 3
Time frame: From the baseline to the end of the study (9 months)
Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
At Stage 1/Step 1, Stage 3
Time frame: From the baseline to the end of the study (9 months)
Response to treatment as measured by the composite response of 2-grade improvement on Investigator's Live Assessment (ILA) at maximum contraction
At stage 1/Step 2, Step 3; 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: At Week 4
Response to treatment as measured by the composite response of 2-grade improvement on subject's self-assessment (SSA) at maximum contraction
At Stage 1/Step 2 and Step 3; 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: At Week 4
Response to treatment as measured by the composite response of 2-grade improvement on ILA at maximum contraction on the forehead lines (FHL) area
At Stage 2 for the glabellar lines (GL)+ FHL group
Time frame: At Week 4
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the forehead lines (FHL) area
At Stage 2 for the glabellar lines (GL)+ FHL group
Time frame: At Week 4
Response to treatment as measured by the composite response of 2-grade improvement ILA at maximum contraction on the lateral canthal lines (LCL) area
At stage 2 for the LCL group
Time frame: At Week 4
Response to treatment as measured by the composite response of 2-grade improvement on SSA at maximum contraction on the LCL area
At stage 2 for the LCL group
Time frame: At Week 4
Response to treatment measured by the composite response of 2-grade improvement on ILA
For all stages. 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: From the baseline to the end of the study (9 months)
Response to treatment measured by the composite response of 2-grade improvement on SSA
For all stages. 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: From the baseline to the end of the study (9 months)
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)
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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)
Time to onset of treatment response based on subject diary cards to evaluate the appearance of their lines
Time frame: From the baseline to the end of the study (9 months)
Satisfaction with facial appearance scale score on the Face-Q satisfaction scale
Face Q is a participant-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the participant's perspective. The Face Q is composed of over 40 scales, covering four domains (Satisfaction with Facial Appearance, Health Related Quality of Life, Adverse Effects, and Process of Care).
Time frame: From the baseline to the end of the study (9 months)
Incidence, severity and nature of treatment emergent adverse events (TEAEs)
Time frame: From baseline to the end of the study (9 months)
Incidence, severity and nature of serious adverse events (SAEs)
Time frame: From baseline to the end of the study (9 months)
Incidence, severity and nature of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs)
Time frame: From baseline to the end of the study (9 months)
Presence of IPN10200 antibodies and titres (binding and neutralizing)
Time frame: At Week 4 , Week 24 and Week 36
Presence of BoNT-A antibodies and titres (binding and neutralizing)
Time frame: At Week 4 , Week 24 and Week 36