Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: JEUNESSO 30L (0.5 ml / 0.8 ml / 1.0 ml) Cross-Linked Sodium Hyaluronate Solution 3% W/V
Composition: Each ml contains:
Cross-Linked Sodium Hyaluronate��..30mg: Dose: Not applicable
Sponsors
Dr Debraj Shome
Eligibility
Inclusion criteria
Inclusion criteria: 1.The patient must be >= 18 and 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 Score (WSS) >= 2 for bilateral 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 NLF area within 4 weeks prior to study entry. In addition, subjects were restricted from undergoing chemical peels at the NLF area for the duration of the study. 7. Had any treatment with Botox® injections: 8. In the upper 1/3 of the face within 2 weeks prior to entry into the study, or 9. In the lower 2/3 of the face within 24 weeks prior to entry. In addition, subjects were restricted from receiving Botox injections in the face for the duration of the study. 10. Had a history of hypo- or hyperpigmentation of the skin. 11. Tolerance to antibiotics or corticosteroids. 12. 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). 13. A known history of keloids or bleeding disorders. 14. Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary disorders. 15. Patient on Medication with blood thinners. 16. Severe physical, neurological or mental disease. 17. Excessive facial hair that might interfere with the study of the wrinkle assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Time points:(Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up)Timepoint: Pre-operative, Day-0, 3 Month, 6 Month & 12 Months Post-Operative Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.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 2. To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 Months 3. 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 Debraj Shome
Esthetic Centers International Pvt. Ltd.
Outcome results
None listed