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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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
Galderma Research Site 2003
Bochum, Germany
Galderma Research Site 2001
Düsseldorf, Germany
Galderma Research Site 2002
Düsseldorf, Germany
Galderma Research Site 1003
Edinburgh, United Kingdom
Time Needed to Prepare Alluzience and Powder BoNT A
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
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
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)
Investigator Treatment Session Questionnaire
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.
Time frame: Baseline (Day 0)
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Galderma Research Site 1004
London, United Kingdom
Galderma Research Site 1006
London, United Kingdom
Galderma Research Site 1001
London, United Kingdom
Galderma Research Site 1002
Street, United Kingdom