Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand

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