A study in people who require facial enhancement through dermal filler (JEUNESSO 30L).

Phase 4

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

• Registration Number: CTRI/2021/12/039025
• Lead Sponsor: Dr Debraj Shome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

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 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified