A Randomized, Multi-center, Patient & Evaluator-blind, Matched pairs, Active-controlled design Clinical study to Evaluate the Efficacy and Safety of Injection with Dermalax (Deep) as Compared to Restylane® in Correction of Nasolabial fold
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0001445
- Lead Sponsor
- Across
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
1.Male or female subjects no younger than 30 and no more than 65 years of age.
2.Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)
*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.
1.Subjects who show hypersensitive skin reaction to the investigational devices, confirmed by the intradermal reaction test performed at screening.
2.Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day) or NSAIDs or Vitamin E within 1 week.
3.Subjects with a liver problem and/or blood coagulation defect or subjects who require the administration of an antithrombotic agent during the clinical trial period (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group, evaluated by the independent evaluator in week 24 from the final application of the investigational device.
- Secondary Outcome Measures
Name Time Method The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group, evaluated by the independent evaluator ;The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group, evaluated by the investigator;The mean of the Global Aesthetic Improvement Scale (GAIS) scores from both the Dermalax (Deep) group and the Restylane® group, evaluated by the investigator