Study Comparing Treatment With Alluzience vs Reconstituted Toxin (STAR)

June 22, 2023 updated by: Galderma R&D

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44791
        • Galderma Research Site 2003
      • Düsseldorf, Germany, 40212
        • Galderma Research Site 2001
      • Düsseldorf, Germany, 40545
        • Galderma Research Site 2002
  • United Kingdom
      • Edinburgh, United Kingdom, EH10 4BE
        • Galderma Research Site 1003
      • London, United Kingdom, W1G 9PF
        • Galderma Research Site 1004
      • London, United Kingdom, W1G 9PF
        • Galderma Research Site 1006
      • London, United Kingdom, W1W 7JF
        • Galderma Research Site 1001
      • Street, United Kingdom, BA16 0HY
        • Galderma Research Site 1002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: Alluzience
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Active Comparator: 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.
Biological: powder BoNT-A (BOTOX/Vistabel)
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0)
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.
Baseline (Day 0)
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.
Baseline (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05PF2005
  • 2021-004748-62 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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