A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

NCT06295172 | Not Yet Recruiting

• 1 other identifier: LF15_NLF_301
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lafullen15

EXPERIMENTAL

PCL filler

Device: Lafullen15

Lafullen

ACTIVE COMPARATOR

PCL filler

Device: Lafullen

Interventions

Lafullen15 DEVICE

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).

Lafullen15

Lafullen DEVICE

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

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
• 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
• History of bleeding disorder in past or present
• 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
• Administered an hyaluronic acid filler within 24 weeks of the date of the screening

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Officials

• Jongho KIM, M.D.,Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gyeongsoon Kim

CONTACT

+82-2-2157-9851; gyeongsoon.kim@samyang.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: May 27, 2024
• Primary Completion: September 30, 2025
• Study Completion: April 30, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-02