Alluzience
BiologicalBotulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
NCT Number: NCT05277337
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).
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Notify Me18 year–65 year
Female
Interventional
Phase 4
Galderma Research Site 2003, Bochum, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Time frame: Baseline (Day 0)
Time to prepare Alluzience and powder Bont A according to protocol was reported.
Time frame: Baseline (Day 0)
Percentage of participants injected with Alluzience for whom investigator did not face technical issue/problems when using a ready-to-use product as compared to a product to be reconstituted, assessed using answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree) was reported.
Time frame: Baseline (Day 0)
Percentage of participants injected with Powder Bont-A for whom investigator experienced issues while reconstitution was assessed using a questionnaire (Yes/No). Percentage of participants with answer "Yes" was reported.
Time frame: Baseline (Day 0)
Treating investigators who injected participant with Alluzience answered questions 1 through 12 of the investigator treatment questionnaire for each participant at baseline. The options for each question were strongly agree, agree, neither agree nor disagree, disagree and strongly disagree.
Galderma R&D
Industry
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
Acronym: STAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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