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

Q-Med AB, part of the Galderma Group0 sites150 target enrollmentNovember 2, 2021

ConditionsModerate to severe glabellar lines (GL).MedDRA version: 21.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858 Therapeutic area: Not possible to specify

DrugsAlluzience®Vistabel® (OnabotulinumtoxinA)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate to severe glabellar lines (GL).
Sponsor: Q-Med AB, part of the Galderma Group
Enrollment: 150
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 2, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Q-Med AB, part of the Galderma Group

Eligibility Criteria

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. A highly effective method of contraception is defined as:
•Bilateral tubal ligation;
•Combined (estrogen and progesterone containing) oral, intravaginal or transdermal contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit;
•Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
•Partner vasectomized for at least three months prior to screening visit;
•Progestogen\-only oral, injectable or implantable contraceptives that inhibit ovulation as the primary mode of action, on a stable dose for at least 28 days prior to screening visit; or
•Strict abstinence (i.e., refraining from heterosexual intercourse for the entire duration of the subject's participation in the study).
•4\.Time and ability to complete the study and comply with instructions.

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.