Healthy Nasolabial Fold corrections Nasolabial Fold corrections Dermal filler Hyaluronic acid Revolax Deep with Lidocaine
Conditions
Interventions
This product is dermal filler which is used for correct medium size and deep wrinkles of the nasolabial fold by injection middle part or dermis layer.,Restylane Defyne is sterile transparent gels comp
Experimental Device,Active Comparator Device
Revolax Deep with Lidocaine,Restylane Defyne
Sponsors
ACROSS Co., Ltd. (in HUGEL Inc.)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged 30-65 years. 2) Subjects with WSRS of 3 or 4 for both sides of their face that want to improve the appearance of their nasolabial folds. The scores do not have to be the same on both sides, but the two nasolabial folds should be visually symmetrical within the specified range of 3-4. 3) Subjects who have discontinued the use of any dermatological procedure(s) or therapies (i.e., facial wrinkle reduction) prior to enrollment. 4) Subjects who are capable of comprehending and abiding by protocol instructions. 5) Subjects who are available throughout the trial period. 6) Subjects who are willing to provide written inform consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who received, or plan to receive coronavirus (MERS-CoV, SARS-CoV, or SARS-CoV-2) vaccination less than 2 weeks from screening. 2) Subjects administered antithrombotic agent(s) less than or equal 2 weeks prior to screening, require antithrombotic agents during the trial period (excluding low dose Aspirin of 100 mg, maximum of 300 mg/day), or nonsteroidal anti-inflammatory drugs (NSAIDs) or Vitamin E less than or equal 1 week prior to screening. Subjects administered Vitamin E should be assessed on a case-by-case basis by the investigator to confirm dosage. Investigators may decide to exclude high-dose Vitamin E subjects to avoid potential antiplatelet effects and bleeding. 3) Subjects with liver problems and/or blood coagulation defects. 4) Subjects with a history of facial topical drug or treatment use less than or equal 4 weeks prior to screening (e.g., steroids, retinoids) or required topical drug or treatment use during the trial period. However, subjects using cosmetic products and devices are not included in this exclusion criteria. 5) Subjects undergoing treatment for wrinkles or acne, facial (chemical) peels, skin rejuvenation procedures, plastic surgeries, and/or botulinum toxin administrations less than or equal 24 weeks prior to screening. 6) Subjects with permanent skin expanders (e.g. soft form or silicone facial implants). 7) Subjects with facial scarring that require medical treatment but have not received any for more than 1 year. 8) Subjects with a history of scars or wounds (e.g., hypertrophic or keloid type scarring) where the investigational device will be administered. 9) Subjects with facial skin diseases or infectious wounds. 10) Subjects with a history of immunodeficiencies or immunocompromise. 11) Subjects with a history of anaphylaxis or severe allergic reactions, or side effects from EMLA cream or other Lidocaine drugs (i.e., during past use of either investigational device). 12)Subjects with severe cardiovascular, digestive, pulmonary, endocrine, or central nerve system illness. 13) Subjects with past or present history of mental illness or disorder. 14) Subjects with records of participation in other clinical trials less than 30 days prior to screening. Subjects who have participated in a clinical trial for aesthetic purposes less than 6 months are permitted to enroll at the investigator discretion. 15) Women of child-bearing potential that do not consent to the use of medically approved methods of contraception over the course of the trial. Medically approved methods of contraception include, but are not limited to, condoms, sustained oral contraceptives use more than or equal 3 months, contraceptive shots or suppositories, or IUDs. 16) Women who are pregnant and/or lactating. 17) Subjects with other clinically significant reason(s) as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean WSRS scores as evaluated by the independent evaluator in week 24 after final administration of Revolax Deep with Lidocaine and Restylane Defyne. week 24 after final administration mean WSRS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean WSRS scores as evaluated by the independent evaluator in week 8, 16, 36, and 48 after final administration of Revolax Deep with Lidocaine and Restylane Defyne. week 8, 16, 36, and 48 after final administration mean WSRS score,Mean WSRS scores as evaluated by the investigator in week 8, 16, 24, 36, and 48 after final administration of Revolax Deep with Lidocaine and Restylane Defyne administration week 8, 16, 24, 36, and 48 after final administration Mean WSRS score,Mean GAIS scores as evaluated by the investigator in week 8, 16, 24, 36, and 48 after final administration of Revolax Deep with Lidocaine and Restylane Defyne week 8, 16, 24, 36, and 48 after final administration mean GAIS score,Mean GAIS scores as evaluated by the subject in week 8, 16, 24, 36, and 48 after final administration of Revolax Deep with Lidocaine and Restylane Defyne week 8, 16, 24, 36, and 48 after final administration mean GAIS score,Proportion of subjects with decreased WSRS scores by equal or greater than 1 level evaluated by the independent evaluator in week 24, 36, and 48 compared with baseline. week 24, 36, and 48 after final administration WSRS scores,Proportion of subjects with decreased WSRS scores by equal or greater than 1 level evaluated by the investigators in week 24, 36, and 48 compared with baseline. week 24, 36, and 48 after final administration WSRS scores | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital
Outcome results
None listed