A Randomized, Split-Hand, Subject-Blinded Study Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital Without Lidocaine for Improved Appearance of the Dorsal Hand in Chinese Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Aging of Dorsal Hands
- Sponsor
- Galderma R&D
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
- Status
- Completed
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated informed consent to participate in the study
- •Chinese origin
- •Age at least 18 years
- •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
- •Subjects eligible for treatment to improve appearance of the dorsal hand by increasing tissue volume
- •Same grade of tissue degeneration and need for treatment in both hands
Exclusion Criteria
- •Any previous non-permanent or permanent implant/filler in the hands, including autologous fat
- •Any mesotherapy or resurfacing procedure (laser, chemical peels or other ablative or non-ablative treatment) in the hands within 6 months prior to baseline
- •Any previous hand surgery including sclerotherapy
- •Any fibrosis or scarring or deformities on the hands
- •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
- •Subjects with active skin disease, inflammation or related conditions in the hand
- •Subjects with a history of precancerous (e.g. actinic keratosis) or cancerous lesions in the hands
- •Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
- •History of neurological disease that may affect peripheral neurological function
- •Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g. rheumatoid arthritis, lupus, scleroderma etc)
Outcomes
Primary Outcomes
The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
Time Frame: 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.