Glabellar Frown Lines
Conditions
Brief 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).
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).
Interventions
BIOLOGICALAlluzience
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
BIOLOGICALpowder BoNT-A (BOTOX/Vistabel)
Botulinum Toxin Type A (BoNT-A) for treatment of glabellar lines; Mode of administration: intramuscular injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Needed to Prepare Alluzience and Powder BoNT A | Baseline (Day 0) | Time to prepare Alluzience and powder Bont A according to protocol was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution | 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. |
| Investigator Treatment Session Questionnaire | 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. |
Countries
Germany, United Kingdom
Participant flow
Recruitment details
The study was conducted at 9 centers in Germany and United kingdom from 04 February 2022 to 12 October 2022.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 99 |
| Group 2 (Powder BoNT-A: BOTOX/Vistabel) 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). | 51 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 (Alluzience) | Group 2 (Powder BoNT-A: BOTOX/Vistabel) | Total |
|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 10.27 | 44.6 years STANDARD_DEVIATION 10.91 | 45.4 years STANDARD_DEVIATION 10.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 46 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 94 Participants | 49 Participants | 143 Participants |
| Sex: Female, Male Female | 99 Participants | 51 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 51 |
| other Total, other adverse events | 18 / 99 | 0 / 51 |
| serious Total, serious adverse events | 0 / 99 | 0 / 51 |
Outcome results
Primary
Time Needed to Prepare Alluzience and Powder BoNT A
Time to prepare Alluzience and powder Bont A according to protocol was reported.
Time frame: Baseline (Day 0)
Population: The full analysis set (FAS) population included all randomized and treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Alluzience) | Time Needed to Prepare Alluzience and Powder BoNT A | 0.55 Minutes | Standard Deviation 0.414 |
| Group 2 (Powder BoNT-A: BOTOX/Vistabel) | Time Needed to Prepare Alluzience and Powder BoNT A | 1.57 Minutes | Standard Deviation 0.831 |
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.
Time frame: Baseline (Day 0)
Population: The full analysis set (FAS) population included all randomized and treated participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Prefer to utilize ready-to-use product than reconstituted product | Strongly Agree/Agree | 80 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Prefer to utilize ready-to-use product than reconstituted product | Neither Agree nor Disagree | 19 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Prefer to utilize ready-to-use product than reconstituted product | Disagree/Strongly disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Gave more time to explain treatment procedure using ready-to-use product than reconstituted product | Strongly Agree/Agree | 96 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Gave more time to explain treatment procedure using ready-to-use product than reconstituted product | Neither Agree nor Disagree | 2 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Gave more time to explain treatment procedure using ready-to-use product than reconstituted product | Disagree/Strongly disagree | 1 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Could save time on the reconstitution and injection procedure to do something else | Strongly Agree/Agree | 92 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Could save time on the reconstitution and injection procedure to do something else | Neither Agree nor Disagree | 7 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Could save time on the reconstitution and injection procedure to do something else | Disagree/Strongly disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Felt more relaxed/less stressed in not having to reconstitute the product to be injected | Strongly Agree/Agree | 68 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Felt more relaxed/less stressed in not having to reconstitute the product to be injected | Neither Agree nor Disagree | 24 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Felt more relaxed/less stressed in not having to reconstitute the product to be injected | Disagree/Strongly disagree | 7 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more secure with pre-diluted solution and don't have to reconstitute the product myself | Strongly Agree/Agree | 64 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more secure with pre-diluted solution and don't have to reconstitute the product myself | Neither Agree nor Disagree | 25 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more secure with pre-diluted solution and don't have to reconstitute the product myself | Disagree/Strongly disagree | 10 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Have a good feeling about injecting a modern and innovative product than reconstituted product | Strongly Agree/Agree | 81 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Have a good feeling about injecting a modern and innovative product than reconstituted product | Neither Agree nor Disagree | 17 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Have a good feeling about injecting a modern and innovative product than reconstituted product | Disagree/Strongly disagree | 1 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | More precise in my injection with a ready-to-use product than reconstituted product | Strongly Agree/Agree | 75 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | More precise in my injection with a ready-to-use product than reconstituted product | Neither Agree nor Disagree | 12 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | More precise in my injection with a ready-to-use product than reconstituted product | Disagree/Strongly disagree | 12 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Like to propose new innovative treatment with liquid ready-to-use product to my patient | Strongly Agree/Agree | 86 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Like to propose new innovative treatment with liquid ready-to-use product to my patient | Neither Agree nor Disagree | 11 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Like to propose new innovative treatment with liquid ready-to-use product to my patient | Disagree/Strongly disagree | 2 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Produced less waste of non-toxin material using ready-to-use product than reconstituted product | Strongly Agree/Agree | 96 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Produced less waste of non-toxin material using ready-to-use product than reconstituted product | Neither Agree nor Disagree | 3 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Produced less waste of non-toxin material using ready-to-use product than reconstituted product | Disagree/Strongly disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | When I use a ready-to-use toxin I spend less materials for injection | Strongly Agree/Agree | 98 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | When I use a ready-to-use toxin I spend less materials for injection | Neither Agree nor Disagree | 1 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | When I use a ready-to-use toxin I spend less materials for injection | Disagree/Strongly disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Believe that the use of ready-to-use toxin is better for the environment as I produce less waste | Strongly Agree/Agree | 99 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Believe that the use of ready-to-use toxin is better for the environment as I produce less waste | Neither Agree nor Disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Believe that the use of ready-to-use toxin is better for the environment as I produce less waste | Disagree/Strongly disagree | 0 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more confident when injecting a product free from animal and human excipients | Strongly Agree/Agree | 82 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more confident when injecting a product free from animal and human excipients | Neither Agree nor Disagree | 17 Participants |
| Group 1 (Alluzience) | Investigator Treatment Session Questionnaire | Feel more confident when injecting a product free from animal and human excipients | Disagree/Strongly disagree | 0 Participants |
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.
Time frame: Baseline (Day 0)
Population: The full analysis set (FAS) population included all randomized and treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Alluzience) | 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 | Strongly Agree | 91.9 percentage of participants |
| Group 1 (Alluzience) | 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 | Agree | 8.1 percentage of participants |
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.
Time frame: Baseline (Day 0)
Population: The full analysis set (FAS) population included all randomized and treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (Alluzience) | Percentage of Participants Injected With Powder Bont-A for Whom Investigator Experienced Issues While Reconstitution | 2 percentage of participants |