A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

Not Applicable

Not yet recruiting

• Conditions: Nasolabial Folds
• Interventions: Device: Lafullen; Device: Lafullen15

• Registration Number: NCT06295172
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Study Start: 2024-05-27
• Primary Completion: 2025-09-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lafullen	Lafullen	PCL filler
Lafullen15	Lafullen15	PCL filler

Primary Outcome Measures

Name	Time	Method
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.