Skip to main content
OpenTrials
Completed

NCT Number: NCT05277337

Study Comparing Treatment With Alluzience vs Reconstituted Toxin

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Galderma Research Site 2003, Bochum, Germany

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alluzience

Biological

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

powder BoNT-A (BOTOX/Vistabel)

Biological

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

Primary outcomes

  1. 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

  1. 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

    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, assessed using answers within each answer option (strongly agree, agree, neither agree nor disagree, disagree and strongly disagree) was reported.

  2. Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution

    Time frame: Baseline (Day 0)

    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.

  3. Investigator Treatment Session Questionnaire

    Time frame: Baseline (Day 0)

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.