Aging
Conditions
Brief summary
IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a stamp-type electronic multineedle injector. OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic multineedle injector, and if changes in skin physiology occur earlier than in previous trials. DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Twenty-four participants completed the study, and no participants withdrew due to adverse effects. INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. The cheek side to which the treatment was applied was chosen randomly.
Detailed description
Twenty-five patients were recruited to this single-center, evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial. Twenty-four participants completed the study, and no participants withdrew due to adverse effects. Each participant submitted to a single treatment with a NASHA injection to one side of the lower cheek. One dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks postinjection). The subjects and two independent investigators assessed the clinical improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit. Adverse events were self-reported by the patients completing a questionnaire.
Interventions
DEVICERestylane Vital
stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Sponsors
Konkuk University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy people older than 25 years
Exclusion criteria
* known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or significant renal, hepatic, or other medical diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydration Level | 12 weeks | We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) \ 120 AU (Arbitrary Unit)(most moist possible) |
| Elasticity | 12 weeks | We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) \ 400 AU(Arbitrary Unit) (inelastic as possible) |
| Melanin Index | 12 weeks | We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) \ 999 AU (Arbitrary Unit) (most dark possible). |
| Erythema Index | 12 weeks | We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of erythema index is 0\ 999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) \ 999 AU (most erythematous possible) |
| Global Aesthetic Improvement Scale (Investigator) | 12 weeks | The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. |
| Global Aesthetic Improvement Scale (Subject) | 12 weeks | The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Vital stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Restylane Vital |
|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 8 |
| Age, Customized 20-29 years | 4 participants |
| Age, Customized 30-39 years | 14 participants |
| Age, Customized 40-49 years | 5 participants |
| Age, Customized 50-59 years | 2 participants |
| elasticity treated side | 294.32 AU (arbitrary unit) STANDARD_DEVIATION 90.25 |
| elasticity untreated side | 272.70 AU (arbitrary unit) STANDARD_DEVIATION 96.89 |
| erythema index treated side | 292.74 AU(arbitrary unit) STANDARD_DEVIATION 71.64 |
| erythema index untreated side | 290.50 AU(arbitrary unit) STANDARD_DEVIATION 59.35 |
| hydration treated side | 45.47 AU (Arbitrary Unit) STANDARD_DEVIATION 10.53 |
| hydration untreated side | 46.21 AU (Arbitrary Unit) STANDARD_DEVIATION 11.35 |
| melanin index treated side | 133.97 AU(arbitrary unit) STANDARD_DEVIATION 25.56 |
| melanin index untreated side | 133.66 AU(arbitrary unit) STANDARD_DEVIATION 27.68 |
| Region of Enrollment Korea, Republic of | 25 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Elasticity
We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany). The range of elasticity was 0 (most elastic possible as) \ 400 AU(Arbitrary Unit) (inelastic as possible)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Elasticity | 242.33 AU (arbitrary unit) | Standard Deviation 72.21 |
| Untreated Side | Elasticity | 271.15 AU (arbitrary unit) | Standard Deviation 86.1 |
Comparison: The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Erythema Index
We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of erythema index is 0\ 999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) \ 999 AU (most erythematous possible)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Erythema Index | 253.66 AU (arbitrary unit) | Standard Deviation 58.19 |
| Untreated Side | Erythema Index | 243.53 AU (arbitrary unit) | Standard Deviation 51.65 |
Comparison: The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Global Aesthetic Improvement Scale (Investigator)
The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Global Aesthetic Improvement Scale (Investigator) | 1.38 scores on a scale | Standard Deviation 0.77 |
| Untreated Side | Global Aesthetic Improvement Scale (Investigator) | 0 scores on a scale | Standard Deviation 0 |
Comparison: The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Global Aesthetic Improvement Scale (Subject)
The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Global Aesthetic Improvement Scale (Subject) | 1.33 scores on a scale | Standard Deviation 1.05 |
| Untreated Side | Global Aesthetic Improvement Scale (Subject) | 0 scores on a scale | Standard Deviation 0 |
Comparison: The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Hydration Level
We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany). The range of hydration level was 0 (as dry as possible) \ 120 AU (Arbitrary Unit)(most moist possible)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Hydration Level | 53.19 AU (arbitrary unit) | Standard Deviation 9.08 |
| Untreated Side | Hydration Level | 46.75 AU (arbitrary unit) | Standard Deviation 9.24 |
Comparison: The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).p-value: <0.05Wilcoxon (Mann-Whitney)
Primary
Melanin Index
We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany). The range of melanin index was 0 (as bright as possible) \ 999 AU (Arbitrary Unit) (most dark possible).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Side (Restylane Vital) | Melanin Index | 147.25 AU (arbitrary unit) | Standard Deviation 27.46 |
| Untreated Side | Melanin Index | 149.00 AU (arbitrary unit) | Standard Deviation 26.86 |
Comparison: The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).p-value: <0.05Wilcoxon (Mann-Whitney)