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The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azzalure alone as single treatment | Experimental | Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
|
| Filler alone as single treatment | Experimental | HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azzalure | Drug | Glabellar lines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) | To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs) | To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits. | 1, 7 and 13 months |
| Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Kestemont, MD | Clinique Science et Beauté, Antibes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mediti Center | Paris | Antibes | 06160 | France | ||
| Centre Medical Saint-Jean |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azzalure Alone as Initial Treatment | Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
| FG001 | Filler Alone as Initial Treatment | HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant withdrew consent after randomization and prior to first treatment. That participant is not included in the analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Azzalure Alone as Initial Treatment | Azzalulre alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
| BG001 | Filler Alone as Initial Treatment |
| 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 | Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs) | To evaluate "Global facial aesthetic appearance" at 7 months compared to at 1 month, blinded evaluator review of photographs. | Posted | Count of Participants | Participants | 7 months |
|
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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 A (Azzalure): After Single Treatment | Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site bruising | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Norberg | Galderma | +46184891267 | maria.norberg@galderma.com |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Restylane/Emervel filler | Device | Facial tissue augmentation |
|
|
| Restylane Skinbooster | Device | Facial skin rejuvenation |
|
|
The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance, compared to the photographs taken before treatment at baseline?" The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved. |
| Month 1, Month 7, and Month 13 |
| Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire) | Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied". | Month 7 and Month 13 |
| Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome | The Investigator answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is met for those subjects that the Investigator answered "Very/somewhat satisfied". | Month 7 and Month 13 |
| Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales) | The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline. | Month 7 and Month 13 |
| Change in Perceived Age of Subjects | To evaluate First impression and perceived age of subjects by evaluation of photos. Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment. | 1 and 7 months, and 1 and 13 months |
| Injected Filler Volume | To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment | Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12) |
| Adverse Event Reporting | To evaluate safety throughout the study period | 0-18 months |
| Arras |
| 62000 |
| France |
| Akademikliniken | Stockholm | 115 42 | Sweden |
| Pregnancy |
|
| Lost to Follow-up |
|
| Medical reason |
|
Filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data on ethnicity only collected for the Swedish site. | Count of Participants | Participants |
|
| Smoking | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs) | To evaluate "Global facial aesthetic appearance" at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits. | Incorrectly taken photographs for six participants were excluded from analysis. Additionally two participants excluded because they were assessed different by all three evaluators. | Posted | Count of Participants | Participants | 1, 7 and 13 months |
|
|
|
| Secondary | Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator | The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: "How would you describe the subject's global facial aesthetic appearance, compared to the photographs taken before treatment at baseline?" The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved. | Number of analyzed subjects decreased over time due to drop-out of study subjects. Data not presented "Per Arm", since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment). | Posted | Number | participants | Month 1, Month 7, and Month 13 |
|
|
|
| Secondary | Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire) | Subjects answered the question "How satisfied are you today with the appearance of your face?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Number of subjects satisfied are those that answered "Very/somewhat satisfied". | Posted | Number | participants | Month 7 and Month 13 |
|
|
|
| Secondary | Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome | The Investigator answered the question "How satisfied are you with the overall facial aesthetic outcome for the subject?" with "Very/somewhat satisfied", "Neither/nor", or "Very/somewhat dissatisfied". Satisfied criteria is met for those subjects that the Investigator answered "Very/somewhat satisfied". | Posted | Number | participants | Month 7 and Month 13 |
|
|
|
| Secondary | Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales) | The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline. | Posted | Number | participants | Month 7 and Month 13 |
|
|
|
| Secondary | Change in Perceived Age of Subjects | To evaluate First impression and perceived age of subjects by evaluation of photos. Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment. | Five participants excluded from analysis due to incorrectly taken photographs. | Posted | Mean | Standard Deviation | years | 1 and 7 months, and 1 and 13 months |
|
|
|
| Secondary | Injected Filler Volume | To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment | For the initial single treatment, only the "Filler alone as initial treatment" participants received filler. At the two combination treatments, all subjects received filler. Data from the "Filler alone as initial treatment" participants are presented for the single treatment while data for all subjects are presented for the combination treatments. | Posted | Mean | Standard Deviation | mL | Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12) |
|
|
|
| Secondary | Adverse Event Reporting | To evaluate safety throughout the study period | Safety population | Posted | Number | Treatment related AEs | 0-18 months |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Group B (Filler): After Single Treatment | Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the single treatment was given but before the 1st combined treatment was given. | 1 | 31 | 4 | 31 |
| EG002 | Group A: After 1st Combined Treatment | Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given. | 0 | 28 | 15 | 28 |
| EG003 | Group B: After 1st Combined Treatment | Group B received filler alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 1st combined treatment was given. | 0 | 28 | 13 | 28 |
| EG004 | Group A: After 2nd Combined Treatment | Group A received Azzalure alone as initial single treatment, and thereafter two combined treatments. Events reported in this section occurred after the 2nd combined treatment was given. | 0 | 28 | 9 | 28 |
| EG005 | Group B: After 2nd Combined Treatment | Group B received filler alone as initial single treatment, and thereafter two combined treatments.Events reported in this section occurred after the 2nd combined treatment was given. | 0 | 28 | 9 | 28 |
| Implant site oedema | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| VII nerve paralysis | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Haematoma | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Inflammatory reaction | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Lump | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nephritic colic | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment | Redness |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Common cold | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
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| 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 |
| Superior Month 13 |
|
|
| Improved Month 13 |
|
|
| Differerence Month 13/Month 1 |
|
|
| Second combined treatment |
|
|