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This study will aim to assess the safety and how effective the next generation of BTX-AHAC (BTX-A-HAC NG) with an injectable liquid formulation is for improving the appearance of lines (wrinkles) betw...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-003841-86

This study will aim to assess the safety and how effective the next generation of BTX-AHAC (BTX-A-HAC NG) with an injectable liquid formulation is for improving the appearance of lines (wrinkles) between the eyebrows (glabellar area) after repeated treatment

Femme et Homme

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Extrait

The objective of the study is to assess short-term efficacy and safety of a single treatment of BTX-A-HAC NG over placebo for the improvement in the appearance of glabellar lines and to assess the long term safety and efficacy of BTX-A-HAC NG after repeated injections. The primary objective will be met by demonstrating the superiority of BTX-A-HAC NG over placebo as measured by the ILA of the appearance of the subject’s glabellar lines at maximum frown on Day 29 of the DB period.

Critère d'inclusion

  • moderate-to-severe glabellar lines

Liens