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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004748-62 | EudraCT Number |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alluzience | Biological | Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Needed to Prepare Alluzience and Powder BoNT A | Time to prepare Alluzience and powder Bont A according to protocol was reported. | Baseline (Day 0) |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site 2003 | Bochum | 44791 | Germany | |||
| Galderma Research Site 2001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38807515 | Derived | 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. |
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A total 153 participants were screened, of which 150 participants were randomized and enrolled, 99 participants in the Alluzience treatment group (Group 1) and 51 in the vacuum-dried botulinum neurotoxin type A (Powder BoNT-A) treatment group (Group 2).
The study was conducted at 9 centers in Germany and United kingdom from 04 February 2022 to 12 October 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Alluzience) | Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0). |
| FG001 | Group 2 (Powder BoNT-A: BOTOX/Vistabel) | Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Alluzience) | Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0). |
| BG001 | Group 2 (Powder BoNT-A: BOTOX/Vistabel) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Needed to Prepare Alluzience and Powder BoNT A | Time to prepare Alluzience and powder Bont A according to protocol was reported. | The full analysis set (FAS) population included all randomized and treated participants. | Posted | Mean | Standard Deviation | Minutes | Baseline (Day 0) |
|
Adverse events were collected from treatment until the end of the participant's participation ( for Alluzience upto 6 months and BOTOX upto 1 month)
The safety population was to include all participants who were administered study product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Alluzience) | Alluzience 0.25 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injecttion Site Pain | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Apr 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2022 | Apr 27, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| powder BoNT-A (BOTOX/Vistabel) | Biological | Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection |
|
| 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. | 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. | Baseline (Day 0) |
| Düsseldorf |
| 40212 |
| Germany |
| Galderma Research Site 2002 | Düsseldorf | 40545 | Germany |
| Galderma Research Site 1003 | Edinburgh | EH10 4BE | United Kingdom |
| Galderma Research Site 1004 | London | W1G 9PF | United Kingdom |
| Galderma Research Site 1006 | London | W1G 9PF | United Kingdom |
| Galderma Research Site 1001 | London | W1W 7JF | United Kingdom |
| Galderma Research Site 1002 | Street | BA16 0HY | United Kingdom |
Injection Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
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| Secondary | 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. | The full analysis set (FAS) population included all randomized and treated participants. | Posted | Number | percentage of participants | Baseline (Day 0) |
|
|
|
| Secondary | 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. | The full analysis set (FAS) population included all randomized and treated participants. | Posted | Number | percentage of participants | Baseline (Day 0) |
|
|
|
| Secondary | 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. | The full analysis set (FAS) population included all randomized and treated participants. | Posted | Count of Participants | Participants | Baseline (Day 0) |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 18 |
| 99 |
| EG001 | Group 2 (Powder BoNT-A: BOTOX/Vistabel) | Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0). | 0 | 51 | 0 | 51 | 0 | 51 |
| Injection Site Haematoma | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA, Version 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA, Version 24.1 | Systematic Assessment |
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Investigators agree not to present/publish any data or reports collected individually or by subgroup of trial sites prior to first publication based on data obtained from all sites. Investigators can publish results 18 months after the completion of the trial, but Sponsor shall have the right to review any proposed publication before publication/presentation to prevent the disclosure of confidential information. Sponsor can refuse the publication, delay it or request amendment of its contents
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Gave more time to explain treatment procedure using ready-to-use product than reconstituted product |
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| Could save time on the reconstitution and injection procedure to do something else |
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| Felt more relaxed/less stressed in not having to reconstitute the product to be injected |
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| Feel more secure with pre-diluted solution and don't have to reconstitute the product myself |
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| Have a good feeling about injecting a modern and innovative product than reconstituted product |
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| More precise in my injection with a ready-to-use product than reconstituted product |
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| Like to propose new innovative treatment with liquid ready-to-use product to my patient |
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| Produced less waste of non-toxin material using ready-to-use product than reconstituted product |
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| When I use a ready-to-use toxin I spend less materials for injection |
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| Believe that the use of ready-to-use toxin is better for the environment as I produce less waste |
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| Feel more confident when injecting a product free from animal and human excipients |
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