A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

Nasolabial Folds Clinical Trial

Official title:

A Randomized, Evaluator-blind, Matched Pairs, Prospective, Non Inferiority, Confirmatory Study to Compare the Safety and Efficacy Between Lafullen15 and Lafullen in the Correction of Nasolabial Folds

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295172
• Other study ID #: LF15_NLF_301
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2024
• Source: Samyang Biopharmaceuticals Corporation
• Contact: Gyeongsoon Kim
• Phone: +82-2-2157-9851
• Email: gyeongsoon.kim[@]samyang.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Est. completion date: April 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Lafullen15
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).
• Lafullen
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samyang Biopharmaceuticals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12months