Study Comparing Treatment With Alluzience vs Reconstituted Toxin

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: Alluzience
* Biological: powder BoNT-A (BOTOX/Vistabel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 18 to < 65 years of age. Moderate to severe GL at maximum frown as assessed by the Investigator. Female of non-childbearing potential (i.e., postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], or has undergone hysterectomy or bilateral oophorectomy). OR Female of childbearing potential with a negative urine pregnancy test at screening and baseline, and agrees to use a highly effective and approved contraceptive method for the duration of the study. Time and ability to complete the study and comply with instructions. Understands the study requirements and signed the informed consent form (ICF). Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site. Previous use of any approved botulinum toxin in facial areas. Exclusion Criteria: Previous use of any botulinum toxin in facial area within 6 months prior to study treatment. Female who is pregnant, breast feeding, or intends to conceive a child during the study. Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype. Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants. Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline. Previous soft tissue augmentation with any permanent (non-biodegradable such as silicone, polyacrylamide, etc) or semi-permanent (i.e., calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) product; lifting threads, or autologous fat in the treatment area. Subject has any prior or current psychiatric illness (e.g. Psychosis, depression, anxiety), alcohol or drug abuse, or is taking antidepressant, anxiolytic, or antipsychotic medication that, in the Investigator's opinion, could affect the subject's safety and/or participation in the study. Other concurrent medical conditions, therapy, or other condition that, in the Investigator's opinion, would interfere with the evaluation of the study medication, safety or efficacy, and/or put the subject at risk if he/she participates in the study. Participation in an investigational device or drug study within 30 days prior to study treatment or plans to enroll in any other investigational study during participation in this study. Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees or close relatives of employees at the Sponsor company.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Alluzience)<br>Single treatment at the baseline visit with Alluzience. Glabellar lines will be treated with 10 U/0.05 mL per injection point. In total 50 s.U in 0.25 mL for 5 injection points. | Biological: Alluzience<br>* Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection<br>|
| Active Comparator: Group 2 (powder BoNT-A: BOTOX/Vistabel)<br>Single treatment at the baseline visit with powder BoNT-A (BOTOX/Vistabel). Glabellar lines will be treated with 4 U/0.1 mL per injection point. In total 20 U in 0.5 mL for 5 injection points. | Biological: powder BoNT-A (BOTOX/Vistabel)<br>* Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to prepare Alluzience and powder BoNT A. | Time to prepare study product according to protocol | Baseline/Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate preparation/reconstitution experience of Alluzience and powder BoNT-A | Proportion of answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree). | Baseline/Treatment | 
| To describe Investigator treatment experience when using Alluzience for the treatment of GL. | Proportion of answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree). | Baseline/Treatment |