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

Not Applicable

Completed

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

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

Brief Summary

This is a prospective, randomized, comparative, clinical study to assess the safety and performance of Cross-linked Hyaluronic Acid- Dermal filler in people with all skin types, who need Lip Enhancement, Cheek bone Augmentation and Nasolabial fold improvement.

Primary objective of this study

1) To Assess and compare the safety and performance of

Crosslinked HA (Biotech’s Dermal filler compared to

Juvederm Voluma XC for cheekbone Augmentation,

Juvederm Ultra Plus XC for nasolabial fold treatment and

Juvederm Volift for Lip Enhancement) for subjects with

a) Cheek bone Augmentation

b) Nasolabial fold improvement

c) Lip Enhancement



2) Incidence of all adverse events at 6 and 12 months and any

systemic adverse events



and Secondary Objectives of this study

1) Assess dermal filler success in overall face improvement.



2) Evaluate and compare efficacy of Cross-linked HA

(Biotech’s dermal filler and Juvederm Voluma XC in Cheek

Bone Augmentation, Juvederm Ultra plus XC in treatment of

nasolabial folds and Juvederm Volift in Lip Enhancement).



3) Evaluate proportion of population reporting with dermal

filler’s adverse effect and during the course of the study.



4) Evaluate and compare long-term safety of Crosslinked HA

(Biotech’s Dermal filler and Juvederm Voluma XC,

Juvederm Ultra Plus XC and Juvederm Volift) up to 12

Months

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• 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 needing Cheek bone Augmentation will be enrolled in arm 1 of the trial.
• The patient with deep depression of the Nasolabial folds will be enrolled in arm 2 of the trial.
• The patient needing Lip Enhancement will be enrolled in arm 3 of the trial.
• The patient agrees to follow-up examinations out to 6 months post final treatment.
• The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for bilateral NLF to be treated.

Exclusion Criteria

• 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.
• 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 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.
• 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.
• Had a history of hypo- or hyperpigmentation of the skin.
• Tolerance 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: 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	Day 0 to 12 Months
study of the safety and severity of adverse events (AEs).	Day 0 to 12 Months

Secondary Outcome Measures

Name	Time	Method
To evaluate the Cheek bone Augmentation, the improvement in the Nasolabial	fold and Evaluate Lip Enhancement from Day 0 to 3, 6 and 12 Months

Trial Locations

Locations (1)

Esthetic Centers International Pvt Ltd; 🇮🇳 Mumbai, MAHARASHTRA, India

Esthetic Centers International Pvt Ltd

🇮🇳Mumbai, MAHARASHTRA, India

Dr Debraj Shome

Principal investigator

9987398578

debraj.shome@theestheticclinic.com