To assess the safety and performance of Cross-linked Hyaluronic Acid- Dermalfiller in people with all skin types, who need Lip Enhancement, Cheek boneAugmentation and Nasolabial fold improvement

Phase 4

• Conditions: Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue

• Registration Number: CTRI/2019/09/021257
• Lead Sponsor: Biotech Vision Care Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 needing Cheek bone Augmentation will be enrolled in arm 1 of the

trial.

5. The patient with deep depression of the Nasolabial folds will be enrolled in arm

2 of the trial.

6. The patient needing Lip Enhancement will be enrolled in arm 3 of the trial.

7. The patient agrees to follow-up examinations out to 6 months post final

treatment.

8. The patient has a pre-treatment Wrinkle Severity Score (WSS) >= 2 for bilateral

NLF to be treated

Exclusion Criteria

1. At risk in term of precautions, warnings and contra-indication referred in the

package insert of the study dermal fillers,

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:

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.

8. Had a history of hypo- or hyperpigmentation of the skin.

9. Tolerance 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: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is responder rate in GAIS Score from Day 0 to 12 Months and <br/ ><br>study of the safety and severity of adverse events (AEs).Timepoint: Day 0 to 12 Months

Secondary Outcome Measures

Name	Time	Method
To evaluate the Cheek bone Augmentation, the improvement in the Nasolabial <br/ ><br>fold and Evaluate Lip Enhancement from Day 0 to 3, 6 and 12 Months <br/ ><br> <br/ ><br> <br/ ><br>To access Global Aesthetic Improvement scale from Day 0 to 3, 6 and 12 <br/ ><br>Months <br/ ><br>To access the frequency and severity of adverse events (AEs) documented at <br/ ><br>each study visitTimepoint: Day 0 to 3, 6, & 12 months