Moderate to Severe Upper Facial Lines Clinical Trial
Official title:
A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults
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 547 participants. The protocol is currently approved up to stage 1, step 1 and stage 1/ step 2. 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 finding step in participants with moderate to severe GL as compared with Dysport Stage 2 (phase II) - An evaluation of efficacy and safety of IPN10200 in one of the following regions: GL + 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)
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