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

Galderma R&D8 sites in 2 countries150 target enrollmentFebruary 4, 2022

ConditionsGlabellar Frown Lines

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Glabellar Frown Lines
Sponsor: Galderma R&D
Enrollment: 150
Locations: 8
Primary Endpoint: Time Needed to Prepare Alluzience and Powder BoNT A
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

February 4, 2022

End Date

October 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Time Needed to Prepare Alluzience and Powder BoNT A

Time Frame: Baseline (Day 0)

Time to prepare Alluzience and powder Bont A according to protocol was reported.

Secondary Outcomes

Investigator Treatment Session Questionnaire(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(Baseline (Day 0))
Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution(Baseline (Day 0))