View clinical trials related to Nasolabial Fold.
Filter by:The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.
The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.
The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated.
This is a randomized, controlled, single-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA®4 injected in NLFs with a cannula is non-inferior to RHA®4 injected in NLFs with a sharp needle (27G x ½") for the correction of moderate to severe NLFs as determined by the Blinded Live Evaluator (BLE) using the Teoxyne NLF-WSRS (proprietary, validated NLF Wrinkle Severity Rating Scale) at 12 weeks from last treatment. At Visit 1 (Week 0), RHA®4 injected with cannula will be administered in a random sequence (first or second injection) and side of the face (left or right NLF) and RHA®4 injected with a sharp needle will be administered to the other side. The TI will administer study devices and will be unblinded to treatment allocation. Blinded assessments of effectiveness will be conducted by the BLE (Blinded Live Evaluator). 4 weeks following initial treatment, subjects will attend Visit 2 and receive, if necessary, touch-up treatments (using a needle or cannula as per the subject's initial treatment assignment). Subjects receiving touch-up treatments at Week 4 (Visit 2) will attend a new Visit 2b (4 weeks following touch-up treatment); subject not receiving touch-up treatment will not attend Visit 2b. After each injection (initial treatment or touch-up), subjects will receive a safety follow-up call from the study site within 3-day. Subjects will then attend scheduled in-office study visits at 8 (Visit 3) and 12 weeks (Visit 4) following last treatment (initial treatment or touch-up) where safety and effectiveness assessments will be conducted.
The aim of this study is to evaluate the safety and effectiveness of pain relief of modified sodium hyaluronate gel for injection when used for the correction of moderate or severe nasolabial folds.
Multicenter (two clinical sites), unblinded, no control group, prospective feasibility study. Subject participation may last up to 24 months after enrollment. Treatment will be performed at Day 1 and optionally at Day 30, with the primary safety and effectiveness evaluation at 2 months. Subjects will continue extended follow-up evaluations at 4, 6, 12, 18 and 24 months after the final injection. The duration and follow-up schedule will be identical, independent of treatment performed.
- Investigational Device : HARA (Hyaluronic Acid Filler) - Title : A Single center, Randomized, Subject & Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds - Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D - Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.
Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.