A study in people who require facial improvement through dermal filler (JEUNESSO20L)
- Conditions
- Health Condition 1: L80-L99- Other disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2023/03/050208
- Lead Sponsor
- Dr. Hemant Talanikar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (Pre-operative, Day-0, 3 Month, 6 Month and <br/ ><br>12 Months Post-Operative Follow-up) <br/ ><br>A. The primary efficacy endpoint is responder rate in GAIS <br/ ><br>Score from Day 0 to 12 Months and study of the safety <br/ ><br>and severity of adverse events (AEs)Timepoint: (Pre-operative, Day-0, 3 Month, 6 Month and <br/ ><br>12 Months Post-Operative Follow-up) <br/ ><br>
- Secondary Outcome Measures
Name Time Method A. To evaluate the Cheek bone Augmentation, the <br/ ><br>improvement in the Nasolabial fold and Evaluate Lip <br/ ><br>Enhancement from Day 0 to 3, 6 and 12 Months <br/ ><br>B. To access Global Aesthetic Improvement Scale from Day <br/ ><br>0 to 3, 6 and 12 Months <br/ ><br>C. To access the frequency and severity of adverse events <br/ ><br>(AEs) documented at each study visitTimepoint: (Pre-operative, Day-0, 3 Month, 6 Month & <br/ ><br>12 Months Post-Operative Follow-up): <br/ ><br>