Health Condition 1: 8- Other Procedures Health Condition 2: null- Patients with facial wrinkles and lip augmentation
Conditions
Interventions
Intervention1: Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection: 2 Ml Prefilled Syringe
Control Intervention1: NA: NA
Sponsors
Biotech Vision Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient must be >= 18 and 2. The patient must be willing to comply with the requirement of the study, including sequential photography or imaging for which copyright will be held by the Sponsor. 3. The patient is willing and able to comply with the study protocol. 4. The patient is seeking soft tissue augmentation treatment on the face. 5. The patient with folds, lines, wrinkles like Malar area, perioral line, Nasolabial fold, marionette Lines, jaw lines. 6. The patient has a pre-treatment Wrinkle Severity Score (WSS) >= 2 for bilateral NLF to be treated 7. The patient agrees to follow-up examinations out to 6 months post final treatment and willing to give written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. At risk in term of precautions, warnings and contra-indication referred in the package insert of the Study devices, 2. Who underwent previous injection of permanent filler in the injected area. 3. Pregnant/lactating women 4. Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic 5. 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. 6. Had any treatment with Botox® injections: a) In the upper 1/3 of the face within 2 weeks prior to entry into the Study, or b) 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. 7. Had a history of hypo- or hyperpigmentation of the skin. 8. Tolerance to antibiotics or corticosteroids. 9. 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). 10. Immunocompromised/immunosuppressed (e.g., HIV-positive, transplant recipient, or presently receiving chemotherapy). 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. 16. Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain assessment during the injection and after the treatment, i.e. at 15, 30, 45 and 60 minutes after injectionTimepoint: Pain assessment during the injection and after the treatment, i.e. at 15, 30, 45 and 60 minutes after injection | — |
Secondary
| Measure | Time frame |
|---|---|
| To access the change in Perioral and Lip Area, from Day 0 to 3 and 6 Months To access Nasolabial fold, from Day 0 to 3 and 6 Months To access Malar Area, from Day 0 to 3 and 6 Months To access Marionette lines severity from Day 0 to 3 and 6 Months To access Jaw Line Severity from Day 0 to 3 and 6 Months To access Global Aesthetic Assessment score from Day 0 to 3 and 6 Months To access the frequency and severity of adverse events (AEs) documented at each study visitTimepoint: Day 0 to 3 and 6 Months | — |
Countries
India
Contacts
Public ContactGirish Hirpara
Apollo Research and Innovations (ARI)
Outcome results
None listed