The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender.
The main questions it aims to answer are:
* Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)? * Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection.
Participants will:
* Receive either Lafullen or Restylane via injection in the nasolabial fold area. * Optionally receive a touch-up injection at 4 weeks after the first treatment if needed. * Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment. * Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety. * Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).
Aged 18 or above, with no gender restriction.
Willing to receive treatment for correcting nasolabial fold.
Treatment investigator evaluate those with a WSRS score of 3 or 4 for bilateral nasolabial folds;
Willing to voluntarily participate in the clinical trial, accepting the obligation not toreceive all plastic surgery and cosmetic dermatology procedures or treatments during the trial。 Willing and able to undergo the required treatment and follow-up observations, and sign the informed consent form.
Allergy to polycaprolactone, hyaluronic acid products or any component of the investigational device or control device(such as streptococcal proteins), allergy to any local anesthetic (such as lidocaine or other amide-typeanesthetic), or history of severe allergic reactions and multiple severe allergic reactions.
Received permanent fillers or prostheses (such as PMMA etc.) or semi-permanent dermal fillers (such as CaHA, PLLA, PCL, etc.).
Received temporary dermal fillers (such as HA and collagen etc.) within 12 months prior to screening.
Received anti-wrinkle surgery within 12 months prior to screening.
Samyang Biopharmaceuticals Corporation
Lead sponsor
Hangzhou Inshow Biotechnology Co.,Ltd.
Collaborator