NCT05277337

Study Comparing Treatment With Alluzience vs Reconstituted Toxin

A Phase IV, Randomized, Interventional, Study to Assess Subject Treatment Session Perception and Investigator Treatment Experience of Alluzience and Vacuum-Dried Botulinum Neurotoxin Type A for Aesthetic Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).

Detailed description

This is a Phase IV, open-label, randomized, interventional, two-armed, multi-centre study to investigate subject treatment perception and Investigator treatment experience when using Alluzience or vacuum-dried botulinum neurotoxin type A (powder BoNT-A) for treatment of glabellar lines (GL).

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	Alluzience	Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
BIOLOGICAL	powder BoNT-A (BOTOX/Vistabel)	Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Timeline

• Start date: 2022-02-04
• Primary completion: 2022-10-12
• Completion: 2022-10-12
• First posted: 2022-03-14
• Last updated: 2024-02-16
• Results posted: 2024-02-16

Locations

8 sites across 2 countries: Germany, United Kingdom