Nasolabial Folds
Conditions
Brief summary
The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds
Interventions
DEVICELafullen15
Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen).
DEVICELafullen
Apply a maximum of 1.0 ml for each side of the nasolabial fold using both the test device (Lafullen15) and the control device (Lafullen).
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study
Eligibility
Sex/Gender
ALL
Age
19 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 |
|---|---|---|
| Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator | 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. |
Contacts
Primary ContactGyeongsoon Kim
Outcome results
None listed