Health Condition 1: L80-L99- Other disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Jeunesso 20L (0.5 ml / 0.8 ml / 1.0 ml)
Cross-Linked Sodium Hyaluronate
Solution 2% W/V
Each ml contains:
Cross-Linked
Sodium Hyaluronate……..20mg
Phosphate Buffer
Saline...........
Sponsors
Dr. Hemant Talanikar
Eligibility
Inclusion criteria
Inclusion criteria: 1.The patient must be = 18 and = 75 years of age. 2. The patient is willing and able to comply with the study protocol. 3. The patient is seeking soft tissue augmentation treatment on the face. 4. The patient agrees to follow-up examinations out to 12 months post final treatment. 5. The patient has a pre-treatment Wrinkle Severity Rating Scale (WSRS) = 2 for bilateral Nasolabial Fold (NLF) to be treated
Exclusion criteria
Exclusion criteria: 1. At risk in term of precautions, warnings and contra indication referred in the package insert of the study dermal filler 2. Who underwent previous injection of permanent filler in the injected area 3. Pregnant/lactating women 4. Participation in any other Clinical trial. 5. Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic 6. Had a chemical peel at the Nasolabial Fold (NLF) area within 4 weeks prior to study entry. In addition, subjects were restricted from undergoing chemical peels at the Nasolabial Fold (NLF) area for the duration of the study 8. Had a history of hypo- or hyperpigmentation of the skin. 9. Inolerance to antibiotics or corticosteroids. 10. Had any infection, unhealed wound, or active inflammatory process (e.g., skin eruptions such as cysts, pimples, rashes, or hives) at the injection site(s). 11. A known history of keloids or bleeding disorders. 12. Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary disorders. 13. Patient on Medication with blood thinners. 14. Severe physical, neurological or mental disease. 15. Excessive facial hair that might interfere with the study of the wrinkle assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Pre-operative, Day-0, 3 Month, 6 Month and 12 Months Post-Operative Follow-up) A. The primary efficacy endpoint is responder rate in GAIS Score from Day 0 to 12 Months and study of the safety and severity of adverse events (AEs)Timepoint: (Pre-operative, Day-0, 3 Month, 6 Month and 12 Months Post-Operative Follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| A. To evaluate the Cheek bone Augmentation, the improvement in the Nasolabial fold and Evaluate Lip Enhancement from Day 0 to 3, 6 and 12 Months B. To access Global Aesthetic Improvement Scale from Day 0 to 3, 6 and 12 Months C. To access the frequency and severity of adverse events (AEs) documented at each study visitTimepoint: (Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up): | — |
Countries
India
Contacts
Public ContactDr Hemant Talanikar
Dr.D.Y.Patil medical college
Outcome results
None listed