A study in people who require facial improvement through dermal filler (JEUNESSO20L)

Phase 4

Completed

• Conditions: Other disorders of the skin and subcutaneous tissue,

• Registration Number: CTRI/2023/03/050208
• Lead Sponsor: Dr. Hemant Talanikar

Brief Summary

this is prospective, single arm, investigator initiated clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler(JEUNESSO 20L) in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.

Primary Objective: 1) To Assess the safety and performance of Crosslinked HA for cheekbone Augmentation, nasolabial fold treatment and Lip Enhancement 2) Incidence of all adverse events at 6 and 12 months and any systemic adverse events.

Secondary Objective: 1) Assess dermal filler success in overall face improvement.2) Evaluate efficacy of Cross-linked HA in Cheek Bone Augmentation, nasolabial folds and Lip Enhancement3) Evaluate proportion of population reporting with dermal filler’s adverse effect during the course of the study.4) Evaluate long-term safety up to 12 Months.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• 1.The patient must be ≥ 18 and ≤ 75 years of age.
• The patient is willing and able to comply with the study protocol.
• The patient is seeking soft tissue augmentation treatment on the face.
• The patient agrees to follow-up examinations out to 12 months post final treatment.
• The patient has a pre-treatment Wrinkle Severity Rating Scale (WSRS) ≥ 2 for bilateral Nasolabial Fold (NLF) to be treated.

Exclusion Criteria

• At risk in term of precautions, warnings and contraindication 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.
• 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.
• Inolerance to antibiotics or corticosteroids.
• 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).
• A known history of keloids or bleeding disorders.
• Leukoderma (Vitiligo) or a family history of leukoderma or other pigmentary disorders.
• Severe physical, neurological or mental disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Pre-operative, Day-0, 3 Month, 6 Month and	(Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
12 Months Post-Operative Follow-up)	(Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
A. The primary efficacy endpoint is responder rate in GAIS	(Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
Score from Day 0 to 12 Months and study of the safety	(Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)
and severity of adverse events (AEs)	(Pre-operative, Day-0, 3 Month, 6 Month and | 12 Months Post-Operative Follow-up)

Secondary Outcome Measures

Name	Time	Method
A. To evaluate the Cheek bone Augmentation, the	improvement in the Nasolabial fold and Evaluate Lip

Trial Locations

Locations (3)

Dr. DY Patil medical college and research centre; 🇮🇳 Pune, MAHARASHTRA, India

Dr. Poppy Dental & Facial Aesthetic Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

May fair Aesthetic Surgery; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. DY Patil medical college and research centre

🇮🇳Pune, MAHARASHTRA, India

Dr Hemant Talanikar

Principal investigator

9422087726

hemant.vasant16@gmail.com