Skin Aging of Dorsal Hands
Conditions
Brief summary
This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects.
Interventions
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
DEVICERestylane Vital
Each subject will receive treatment on Day 1 with Restylane Vital in one hand and the experimental device in the opposite hand, as randomly assigned
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine® in one hand and Restylane Vital in the opposite hand, as randomly assigned. Subject was kept bline is that he/she does not know which product treatment their hands received separately
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent to participate in the study 2. Chinese origin 3. Age at least 18 years 4. The subject is willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions 5. Subjects eligible for treatment to improve appearance of the dorsal hand by increasing tissue volume 6. Same grade of tissue degeneration and need for treatment in both hands
Exclusion criteria
1. Any previous non-permanent or permanent implant/filler in the hands, including autologous fat 2. Any mesotherapy or resurfacing procedure (laser, chemical peels or other ablative or non-ablative treatment) in the hands within 6 months prior to baseline 3. Any previous hand surgery including sclerotherapy 4. Any fibrosis or scarring or deformities on the hands 5. Advanced photoaged/ photodamaged skin (e.g. advanced skin elastosis, multiple lentigo solaris lesions) or skin condition with very crinkled or fragile skin on the dorsal hands 6. Subjects with active skin disease, inflammation or related conditions in the hand 7. Subjects with a history of precancerous (e.g. actinic keratosis) or cancerous lesions in the hands 8. Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation 9. History of neurological disease that may affect peripheral neurological function 10. Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g. rheumatoid arthritis, lupus, scleroderma etc) 11. Subjects with known hypersensitivity to any ingredient of the study product or anesthesia used in the study or with a history of any significant Adverse Events caused by dermal fillers 12. Use of topical retinoids on the dorsal hands within 6 weeks prior to baseline or use of systemic retinoids within 6 months prior to baseline 13. History of chronic lymph edema or breast cancer /mastectomy with potential to cause edema 14. Concomitant thrombolytic or anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriod anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders. Cyclooxygenase-2 (COX-2) inhibitors are allowed 15. Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (dorsal hands) corticosteroids (inhaled corticoids are allowed) within three months before study treatment 16. History of untreated epilepsy or other significant medical conditions 17. Women who are pregnant or breast feeding, or Woman of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period. 18. Subjects participating in another interventional clinical study within 30 days of baseline 19. Subjects with unattainable expectation with regard to the aesthetic results of the treatment 20. Subjects who are involved in conducting the study (e.g. colleagues within the same department) or close relatives to any of the study staffs (e.g. parents, children, siblings or spouse ) as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company 21. Subjects with any other condition which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0). | End of Injection (T0) | The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled no pain at the left end and the worst pain you can imagine at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently. |
Countries
China
Participant flow
Pre-assignment details
Total 90 participants were enrolled in this study, each participant received Restylane Skinbooster vital lidocaine treatment on one hand, and Restylane Vital on his/her other hand.
Participants by arm
| Arm | Count |
|---|---|
| Restylane Skinboosters Vital Lidocaine and Restylane Vital Subjects' hands treated by Restylane Skinboosters Vital Lidocaine and Restylane Vital
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned. | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | Restylane Skinboosters Vital Lidocaine and Restylane Vital |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants |
| Age, Continuous | 40.2 years |
| Race/Ethnicity, Customized Chinese Origin | 90 Participants |
| Region of Enrollment China | 90 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 3 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled no pain at the left end and the worst pain you can imagine at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.
Time frame: End of Injection (T0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Restylane Skinboosters Vital Lidocaine | The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0). | 32.5 score on a scale | Standard Deviation 19.41 |
| Restylane Vital | The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0). | 46.9 score on a scale | Standard Deviation 23.43 |
Comparison: Within-Subject Difference in VAS Score at the End of Injection (FAS)p-value: <0.0001t-test, 1 sided