Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects intent to undergo facial filler treatment for either volume loss or contouring * Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin) * Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance * Facial appearance as Han Chinese * Non-pregnant, non-breast feeding female * Signed informed consent
Exclusion criteria
* Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated. * History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose). * Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose). * Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area. * Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment. * Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment. * Previous revitalization with neurotoxin in the facial area within six (6) months before treatment. * Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment. * Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Improved in Global Facial Aesthetic Appearance - Judged by Participant | 6 Months | Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered improved if she answers Very much improved, Much improved, or Improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 6 and 12 Months after first and second treatment, respectively | The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is No folds and 4 is Very severe folds. A participant is considered improved if she scores at least one grade improvement from baseline. |
| Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 6 and 12 Months after first and second treatment, respectively | The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is Full upper cheek and 4 is Very severely sunken upper cheek. A participant is assessed as improved if she scores at least one grade improvement from baseline. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intradermal Injection Restylane and/or Perlane
Restylane: Facial tissue augmentation
Perlane: Facial tissue augmentation | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| First Treatment | Adverse Event | 1 |
| First Treatment | Withdrawal by Subject | 1 |
| Second Treatment | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Intradermal Injection |
|---|---|
| Age, Continuous | 39.7 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment Taiwan | 100 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 34 / 100 |
| serious Total, serious adverse events | 5 / 100 |
Outcome results
Primary
Percentage of Participants Improved in Global Facial Aesthetic Appearance - Judged by Participant
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered improved if she answers Very much improved, Much improved, or Improved.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intradermal Injection | Percentage of Participants Improved in Global Facial Aesthetic Appearance - Judged by Participant | 95 percentage of participants |
Secondary
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is No folds and 4 is Very severe folds. A participant is considered improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
Population: In total, 88 participants were injected in the right NLF and 86 participants were injected in the left NLF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intradermal Injection | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 6 Months after first treatment | 54 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 12 Months after first treatment | 47 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 6 Months after second treatment | 65 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 12 Months after second treatment | 54 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 12 Months after second treatment | 55 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 6 Months after first treatment | 65 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 6 Months after second treatment | 62 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator | 12 Months after first treatment | 46 percentage of participants |
Secondary
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is Full upper cheek and 4 is Very severely sunken upper cheek. A participant is assessed as improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
Population: All 100 participants were injected in the upper cheeks, but 1 participant was not injected in left upper cheek at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intradermal Injection | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 6 Months after first treatment | 66 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 12 Months after first treatment | 38 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 6 Months after second treatment | 77 percentage of participants |
| Intradermal Injection | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 12 Months after second treatment | 69 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 12 Months after second treatment | 71 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 6 Months after first treatment | 67 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 6 Months after second treatment | 78 percentage of participants |
| Left Nasolabial Fold | Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator | 12 Months after first treatment | 43 percentage of participants |