A Randomized, Single-center, Subject and Evaluator-blind, Matched-pair, Active-control, Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Revolax Deep with Lidocaine Administrations Compared to Restylane Defyne for Nasolabial Fold Corrections.
- Conditions
- HealthyNasolabial Fold correctionsNasolabial Fold correctionsDermal fillerHyaluronic acidRevolax Deep with Lidocaine
- Registration Number
- TCTR20240626005
- Lead Sponsor
- ACROSS Co., Ltd. (in HUGEL Inc.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method