RESTRUCTURING THE MANDIBULAR ANGLE IN FACIAL AGING: A NOVEL TECNIQUE USING POLY-L-LACTIC ACID

Launched by DORIS HEXSEL · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new method for improving the appearance of the lower part of the face, specifically the area around the jawline, which can sag as we age. The study will test a substance called poly-L-lactic acid (PLLA), which helps the body produce collagen—a protein that keeps skin firm and youthful. Unlike traditional facelift surgery, which is more invasive, this technique is less invasive and aims to give a natural lift to the face while enhancing its overall shape.

To participate, individuals must be between 18 and 65 years old and in good health. Participants will receive injections of PLLA at three different visits over a few months, and their progress will be monitored through questionnaires and photographs. This trial is a great opportunity for those looking to rejuvenate their facial appearance without major surgery. Please note that certain medical conditions or recent cosmetic treatments may exclude some potential participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female individuals aged between 18 and 65 years of age.
• • 2. Immunocompetent individuals.
• • 3. Medical history and physical examination that, in the opinion of the investigator, do not prevent or contraindicate participation in the study or the use of the investigational product.
• • 4. Female research participants of childbearing potential with a negative UPT at baseline (Day 1). These participants must use a highly effective contraceptive method throughout the study: combined oral contraceptives (estrogen and progesterone) or implanted/injectable contraceptives (with a stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month before entering the study), strict abstinence (at least 1 month prior to study entry and agreeing to continue throughout the study duration), vasectomized partner (at least 3 months before study entry), or condom use.
• • 5. Women not of childbearing potential (e.g. postmenopausal with no menstrual bleeding for 1 year prior to study entry, hysterectomy, or bilateral oophorectomy).
• • 6. Research participants who are willing and able to comply with the duration and procedures required by the study protocol.
• • 7. Research participants who understand and sign the ICF and the ICF for image use authorization upon entering the study, before any investigational procedures are performed.
• Exclusion Criteria:
• • 1. Participants unable to understand the research protocol and/or follow the study schedule.
• • 2. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
• • 3. History of treatment in the past 6 months or planning to undergo procedures with lasers, intense pulsed light, radiofrequency, microfocused ultrasound, or deep chemical peels.
• • 4. History of treatment with botulinum toxin on the face in the past 6 months or planning to undergo this procedure.
• • 5. History of treatment with hyaluronic acid-based or other non-permanent dermal fillers on the face in the past 12 months, or planning to undergo this procedure.
• • 6. History of treatment with collagen biostimulators on the face, such as poly-L-lactic acid (PLLA), calcium hydroxyapatite, or polycaprolactone, in the past 36 months, or planning to undergo this procedure.
• • 7. History of treatment with or planning to use permanent fillers on the face.
• • 8. Current use, use within the past 3 months, or planned use of collagen-based supplements.
• • 9. Any surgical procedure or other treatment previously performed that has affected the area to be assessed in this study.
• • 10. Active inflammation or infections in the facial region.
• • 11. Severe psychiatric disorders.
• • 12. Any other uncontrolled, chronic, or severe medical condition that, in the investigator's opinion, may interfere with the interpretation of the clinical study results or pose significant risk to the research participant.
• • 13. History of sensitivity to any component of the product used in the study.
• • 14. Vulnerable participants (such as those deprived of liberty), as defined in Section 1.61 of the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
• • 15. History of poor treatment adherence or demonstrated lack of cooperation in adhering to the study protocol.
• • 16. Current participation in any other drug or device clinical study OR participation within 30 days prior to Day 1 or within an exclusion period of a previous clinical study.