Aging
Conditions
Brief summary
The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers. This will be an open, multi-centre study.
Interventions
DRUGBotulinum Toxin Type A (Azzalure)
Powder for solution for injection
DEVICERestylane ranges
Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria Main
Exclusion criteria
* Female subject who is pregnant, nursing or planning a pregnancy during the study * Subject with any contraindications to the injection of hyaluronic acid (see package inserts) * Subject with any contraindications to the injection of botulinum toxin (see package insert) * Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin * Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments * Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations * Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction for the Full Face | Month 6 | based on the subject's satisfaction questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement From Baseline | Week 3 | The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved. |
| Related Adverse Event | Month 6 | Number of subjects reporting related adverse events |
Countries
France, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azzalure and Restylane All subjects will be injected with Azzalure and Restylane
Botulinum Toxin Type A (Azzalure): Powder for solution for injection
Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh) | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Azzalure and Restylane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 47.6 years STANDARD_DEVIATION 7.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment France | 20 participants |
| Region of Enrollment Spain | 20 participants |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
Subject Satisfaction for the Full Face
based on the subject's satisfaction questionnaire
Time frame: Month 6
Population: only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azzalure and Restylane | Subject Satisfaction for the Full Face | neutral | 7.1 percentage of total subjects |
| Azzalure and Restylane | Subject Satisfaction for the Full Face | satisfied or very satisfied | 92.9 percentage of total subjects |
Secondary
Global Aesthetic Improvement From Baseline
The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved.
Time frame: Week 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azzalure and Restylane | Global Aesthetic Improvement From Baseline | Improved | 0 percentage of total subjects |
| Azzalure and Restylane | Global Aesthetic Improvement From Baseline | Much or very much improved | 100 percentage of total subjects |
Secondary
Related Adverse Event
Number of subjects reporting related adverse events
Time frame: Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Azzalure and Restylane | Related Adverse Event | 14 participants |