Healthy Nasolabial Fold corrections Nasolabial Fold corrections, Dermal filler, Hyaluronic acid, Revolax Fine with Lidocaine
Conditions
Interventions
REVOLAX Fine with Lidocaine is a dermal filler which is used for correct medium size and deep wrinkles of the face by injection middle part or dermis layer which is supplied in a disposable glass syri
Experimental Device,Active Comparator Device
Revolax Fine with Lidocaine,Restylene Refyne
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 aged 30-65 years. 2) Subject with a WSRS score of 3 or 4 for both sides of their face who wants 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) Subject has discontinued the use of any dermatological procedure(s) or therapies (i.e., facial wrinkle reduction) before screening and enrollment. Discontinuation is defined by at least 1 year of discontinued use for dermal fillers and at least 6 months for any other dermatological procedure. 4) Subject is capable of comprehending and abiding by protocol instructions. 5) Subject is available throughout the trial period. 6) Subject is willing to provide written inform consent.
Exclusion criteria
Exclusion criteria: 1) Subject who received, or plans to receive, coronavirus (MERS-CoV, SARS-CoV, or SARS-CoV-2) vaccination within 2 weeks of screening. 2) Subject administered antithrombotic agent(s) within 2 weeks before screening, who requires antithrombotic agents during the trial period (not including low dose Aspirin within 300 mg/day,), or nonsteroidal anti-inflammatory drugs (NSAIDs) or Vitamin E within 1 week before 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) Subject has liver problems and/or blood coagulation defects. 4) Subject has facial topical drug or treatment (e.g., steroids, retinoids) use within 4 weeks of screening or requires topical drug or treatment use during the trial period. Subjects using cosmetic products and devices are not included in this criteria. 5) Subject received treatment for wrinkles or acne (e.g., facial [[chemical]] peels, skin rejuvenation procedures, plastic surgeries, and/or botulinum toxin administrations) within 24 weeks of screening. 6) Subject receives fillers, other soft tissue augmentation, or biostimulator injections in their nasolabial fold(s) within 12 months before screening. 7) Subject has permanent skin expanders (e.g., soft form or silicone facial implants). 8) Subject has facial scarring that require medical treatment but shas not received any treatments for more than 1 year. 9) Subject has a history of scars or wounds (e.g., hypertrophic or keloid type scarring) where the investigational device will be administered. 10) Subject has facial skin diseases or infectious wounds. 11) Subject has a history of immunodeficiencies or immunocompromise. 12) Subject has a history of anaphylaxis or severe allergic reactions, or side effects from eutectic mixture of local anesthetics (EMLA) cream or other Lidocaine drugs (i.e., during past use of either investigational device). 13) Subject has severe cardiovascular, digestive, pulmonary, endocrine, or central nerve system illness. 14) Subject has a past or present history of mental illness or disorder. 15) Subjects has a record of participating in another clinical trials within 30 days of screening. Subjects who have participated in a clinical trial for aesthetic purposes within 6 months are permitted to enroll at the investigators discretion. 16) Subject is a woman of child-bearing potential who does not consent to abstaining from sexual intercourse or using 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 at least 3 months, contraceptive shots or suppositories, or IUDs. 17) Subject is a woman who is pregnant and/or lactating. 18) Subjects has some other clinically significant reason, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WSRS scores week 24 after final administration. Mean WSRS scores as evaluated by the independent evaluator | — |
Secondary
| Measure | Time frame |
|---|---|
| WSRS scores week 8, 16, 36, and 48 after final administration. Mean WSRS scores as evaluated by the independent evaluator,WSRS scores week 8, 16, 24, 36, and 48 after final administration. Mean WSRS scores as evaluated by the investigator,GAIS scores week 8, 16, 24, 36, and 48 after final administration. Mean GAIS scores as evaluated by the investigator ,GAIS scores week 8, 16, 24, 36, and 48 after final administration. Mean GAIS scores as evaluated by the subject,The proportion of subjects with decreased WSRS scores by at least 1 level compared with baseline week 24, 36, and 48 after final administration The proportion of subjects with decreased WSRS scores by at least 1 level as evaluated by the independent evaluator,The proportion of subjects with decreased WSRS scores by at least 1 level compared with baseline week 24, 36, and 48 after final administration The proportion of subjects with decreased WSRS scores by at least 1 level as evaluated by the investigator | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital
Outcome results
None listed