Study Comparing Treatment With Alluzience vs Reconstituted Toxin

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2022-10-12

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).

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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).

Conditions

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Glabellar Frown Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (Alluzience)

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.

Group Type EXPERIMENTAL

Alluzience

Intervention Type BIOLOGICAL

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Group 2 (powder BoNT-A: BOTOX/Vistabel)

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.

Group Type ACTIVE_COMPARATOR

powder BoNT-A (BOTOX/Vistabel)

Intervention Type BIOLOGICAL

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Interventions

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Alluzience

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Intervention Type BIOLOGICAL

powder BoNT-A (BOTOX/Vistabel)

Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Female 18 to \< 65 years of age.
2. Moderate to severe GL at maximum frown as assessed by the Investigator.
3. 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.
4. Time and ability to complete the study and comply with instructions.
5. Understands the study requirements and signed the informed consent form (ICF).
6. Subjects who have planned to undergo aesthetic facial treatment with powder toxin at the study site.
7. Previous use of any approved botulinum toxin in facial areas.

Exclusion Criteria

1. Previous use of any botulinum toxin in facial area within 6 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the study product or any botulinum toxin serotype.
4. Any known contraindication such as subject with bleeding disorder or subject currently using anticoagulants.
5. Previous use of any hyaluronic acid soft tissue augmentation therapy in the treated area within 3 months before baseline.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No