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)
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of treatment emergent adverse events (TEAEs) at each dose
Timeframe: From the baseline to the end of the study (9 months)
Incidence of serious adverse events (SAEs) at each dose
Timeframe: 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)
Timeframe: From the baseline to the end of the study (9 months)
Response to treatment at Stage 2 for the FHL group
Timeframe: At Week 4
Response to treatment at Stage 2 for the glabellar lines (GL)+ FHL group
Timeframe: At Week 4
Response to treatment at Stage 2 for the LCL group
Timeframe: At Week 4
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Timeframe: From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings
Timeframe: From the baseline to the end of the study (6 years, 5 months)
Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination.
Timeframe: From the baseline to the end of the study (6 years, 5 months)