A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

Launched by SAMYANG BIOPHARMACEUTICALS CORPORATION · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new product called Lafullen15 to see if it can safely and effectively improve the appearance of nasolabial folds, which are the lines that run from the sides of your nose to the corners of your mouth. The study aims to find out if Lafullen15 is a better option compared to the original Lafullen. The trial is not yet recruiting participants, but it's open to anyone aged between 18 and 65 who has noticeable nasolabial folds and is looking for improvement.

To be eligible for this study, participants should have a moderate to severe score on a wrinkle scale, indicating they want to reduce the appearance of these lines. They must also agree not to undergo any other skin treatments during the study. However, people with certain health conditions, recent treatments, or those who have taken specific medications in the weeks leading up to the study may not qualify. Participants can expect to receive the treatment and will be monitored for safety and effectiveness throughout the trial.

Gender

ALL

Eligibility criteria

• 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