Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: 2%Sodium Hyaluronate: Subjects will receiveSodium hyaluronate 2% on one side of dorsum of the hand as per the randomization
Control Intervention1: Restylane Vital: Subjects will receive
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained 2. Male or female subjects 25-60 years of age, inclusive. 3. Visible signs of skin aging in the hands (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion. 4. Subjects must be cooperative and willing to comply with the instructions and procedures.
Exclusion criteria
Exclusion criteria: 1. Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage. 2. History of or active collagenosis (e.g. systemic lupus, erythematosis, rheumatic arthritis, skin or systemic sclerosis). 3. Previous hypersensitivity to hyaluronic acid. 4. Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the baseline visit. 5. History of cancerous or pre-cancerous lesions in the face, hands and décolletage. 6. Previous tissue augmenting therapy with non-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit. 7. Use of injectable revitalization preparations (e.g. Hyal System®, Restylane Vital, Hyfil) within 12 months prior to the baseline visit. 8. Use of retinoic acid within 6 months prior to the baseline visit. 9. Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids. 10. History of treatment with permanent filling materials. 11. Pregnancy or breast feeding woman or woman of childbearing potential not practicing adequate contraception. 12. Participation in any other clinical study within 30 days prior to the baseline visit or plan to participate in another clinical study during this study period. 13. Unrealistic expectation with regard to the esthetic results of the treatment. 14. Alcohol or drug or medication abuse; 15. Protocol non-compliant subjects; 16. Any significant laboratory findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in elasticity and skin structure from baseline to each treatment session and 3 and 6 months after the last treatment session assessment by investigator.Timepoint: 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in global aesthetic improvement scale (GAIS) from baseline to each treatment session and 3 and 6 months after the last treatment session - assessment by investigator;Timepoint: 3 and 6 months;2. Changes in global aesthetic improvement scale (GAIS) from baseline to each treatment session and 3 and 6 months after the last treatment session - assessment by patientTimepoint: 3 and 6 months;4. Physician satisfaction score with regard to Device usage (Sodium hyaluronate 2%/Restylane Vital)Timepoint: 3 and 6 months;Patient satisfaction scoreTimepoint: 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed