Nasolabial Folds
Conditions
Brief summary
The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.
Interventions
DEVICESYB Filler (SF-01)
Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
DEVICEEllansé M
Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A Randomized, Subject & Evaluator-blind, Matched pairs, Prospective Study
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) 2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.
Exclusion criteria
1. Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening 2. Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study 3. History of bleeding disorder in past or present 4. Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening 5. Administered an hyaluronic acid filler within 24 weeks of the date of the screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed | 12months | The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome. |
Countries
South Korea
Outcome results
None listed