Glabellar Frown LinesPhase 4STARNCT05277337
Study Comparing Treatment With Alluzience vs Reconstituted Toxin
A Phase 4 study testing Alluzience and powder BoNT-A (BOTOX/Vistabel) in people with Glabellar Frown Lines, run by Galderma R&D at 8 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Alluzience and powder BoNT-A (BOTOX/Vistabel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Feb 2022to 12 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United Kingdom5 sites
Galderma Research Site 1003
Edinburgh, EH10 4BE
Galderma Research Site 1004
London, W1G 9PF
Galderma Research Site 1006
London, W1G 9PF
Galderma Research Site 1001
London, W1W 7JF
Galderma Research Site 1002
Street, BA16 0HY
Germany3 sites
Galderma Research Site 2003
Bochum, 44791
Galderma Research Site 2001
Düsseldorf, 40212
Galderma Research Site 2002
Düsseldorf, 40545
About this study
Official 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
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).
Read the 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).
- Conditions
- Glabellar Frown Lines
- Being tested
- Alluzience, powder BoNT-A (BOTOX/Vistabel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlluzienceBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Alluzience) | Experimental | 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. Receives: Biological: Alluzience |
| Group 2 (powder BoNT-A: BOTOX/Vistabel) | Active comparator | 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. Receives: Biological: powder BoNT-A (BOTOX/Vistabel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Needed to Prepare Alluzience and Powder BoNT A
Time to prepare Alluzience and powder Bont A according to protocol was reported.
Measured: Baseline (Day 0)
Secondary outcomes (3)
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
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.
Measured: Baseline (Day 0)
Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution
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.
Measured: Baseline (Day 0)
Investigator Treatment Session Questionnaire
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.
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Feb 2022
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277337
- Sponsor's protocol ID
- 05PF2005
- Other IDs
- 2021-004748-62
- Acronym
- STAR
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2022
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chadha P, Gerber PA, Hilton S, Molina B, Haq S, Partridge J, Wong V, Hoffmann K, Persson C, Prygova I. Ready-to-use abobotulinumtoxinA solution versus powder botulinumtoxinA for treatment of glabellar lines: Investigators' and subjects' experience in a Phase IV study. J Cosmet Dermatol. 2024 Sep;23(9):2857-2866. doi: 10.1111/jocd.16359. Epub 2024 May 28.
PubMed 38807515
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05277337
- Acronym / sponsor ID
- STAR / 05PF2005
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Posted 16 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Alluzience) | Experimental | Biological: AlluzienceSingle 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 2 (powder BoNT-A: BOTOX/Vistabel) | Active comparator | Biological: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlluzienceBotulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection | Biological | Group 1 (Alluzience) |
| powder BoNT-A (BOTOX/Vistabel)Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection | Biological | Group 2 (powder BoNT-A: BOTOX/Vistabel) |
Primary outcome
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.
3 secondary outcomes
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 Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution
Time frame: Baseline (Day 0)
Investigator Treatment Session Questionnaire
Time frame: Baseline (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38807515Chadha P, Gerber PA, Hilton S, Molina B, Haq S, Partridge J, Wong V, Hoffmann K, Persson C, Prygova I. Ready-to-use abobotulinumtoxinA solution versus powder botulinumtoxinA for treatment of glabellar lines: Investigators' and subjects' experience in a Phase IV study. J Cosmet Dermatol. 2024 Sep;23(9):2857-2866. doi: 10.1111/jocd.16359. Epub 2024 May 28.
- Individual participant dataSharing planned: No
Related trials for Glabellar Frown Lines
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Active, not recruitingPhase 1
Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
Glabellar Frown Lines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alluzience and powder BoNT-A (BOTOX/Vistabel) in people with Glabellar Frown Lines, run by Galderma R&D at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Needed to Prepare Alluzience and Powder BoNT A (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.