Comparative clinical study of efficacy and safety between GESELLELIGNE and Juvederm Voluma for restoration of mid-face volume deficit; A multi-center, randomized, single-blinded, investigator initiated trial

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 17, 2022

Last Updated

3 years ago

Study Type

Interventional Study

Sex

All

Sponsor

•1\) Men and women between the ages of 30 and 65
•2\) Those who need correction of mid\-face volume deficit scale (MFVDS) grade 2 or higher facial volume
•3\) Those whose face volume is bilaterally symmetrical
•4\) Those who agreed not to undergo other facial correction procedures during the clinical trial period
•5\) A person who is willing to participate in a clinical trial, comply with treatment and procedures, and visit a hospital for all observation evaluations
•6\) A person who voluntarily signed a written consent after hearing the explanation about the purpose and method of this clinical trial

•1\) Those who have taken anticoagulants within 2 weeks before participating in the clinical trial (however, low\-dose (300 mg/day or less) aspirin administration is allowed.)
•2\) Those who have applied calcium hydroxyapatite (CaHA) to the target area of this study within 1 year before participating in the clinical trial
•3\) Those who administer immunosuppressants
•4\) Those who have undergone permanent filler treatment or fat grafting in the area subject to this study
•5\) Those who have undergone wrinkle correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, middle skin peel, dermal photorejuvenation, etc.) within 6 months prior to participation in the clinical trial
•6\) Those with a history of hypersensitivity to lidocaine or hyaluronic acid
•7\) Those with a history of keloid formation or hypertrophic scars on the face
•8\) Those with a history of streptococcal infectious disease on the face
•9\) Subjects with wounds, scars, skin disorders or infections around the area subject to this study that may affect efficacy evaluation
•10\) If those are pregnant or lactating, or if those are a woman of childbearing age, those do not agree to maintain contraception during the clinical trial period (\*Medically accepted contraception methods: use condoms, oral contraception continued for at least 3 months, or injection or insertion contraceptives) If those do, if those have an intrauterine contraceptive device installed, etc.)