UnknownNot Applicable

A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement

73 participantsStarted 2024-05-27

Plain-language summary

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

Who can participate

Age range19 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 12months

Trial details

NCT IDNCT06295172

SponsorSamyang Biopharmaceuticals Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Gyeongsoon Kim

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

View on ClinicalTrials.gov More Nasolabial Folds trials