A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

Samyang Biopharmaceuticals Corporation

Status: Not yet enrolling

Conditions: Nasolabial Folds

Treatments: Device: Lafullen; Device: Lafullen15

Study type: Interventional

Funder types: Industry

Identifiers

NCT06295172

LF15_NLF_301

Details and patient eligibility

About

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

Enrollment: 73 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Lafullen15

Experimental group

Description:

PCL filler

Treatment:

Device: Lafullen15

Lafullen

Active Comparator group

Description:

PCL filler

Treatment:

Device: Lafullen