Clinical Research Directory

Post-market Clinical Follow-up (PMCF) Study of Safety and Performance of 502-01 AnGelHA 2

Post-market clinical follow-up (PMCF) investigation to evaluate the performance and safety of AnGelHA 2 filler for the correction of moderate to severe wrinkles and folds and facial contour remodeling, in a routine clinical setting.

Prospective Clinical Evaluation of the Safety and Performance of the Aesthetic Medical Device MEC REGENERATE® (Injectable Recombinant Collagen-based Product)

Prospective, spontaneous, open-label pre-market clinical trial with a single injection session; monitoring visits at baseline and 60 days post-treatment. Two visits will be conducted during the study: * a baseline visit, during which the first injection will be administered * a final visit, 60 days after the baseline visit, for final assessment The experimental design involves injection into the deep subdermal layer with the investigational product during the baseline visit, following the study procedure assessments. Typically, 0.9 ml per side of the face is administered using the retrograde fan technique. The study duration is 2 months; safety evaluation will be conducted using non-invasive instrumental assessments such as skin hydration (corneometry) and medical device safety and subjective assessments (see below).

A Clinical Study to Test the Safety and Effectiveness of Pinorox® for Improving Visible Signs of Facial Aging Such as Wrinkles, Fine Lines, and Dark Spots.

A Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects with Facial Signs of Aging

Clinical Study to Assess Safety, Effectiveness and In-Use Tolerability of Saffron Extract Capsules for Improving Skin Health and Reducing Signs of Aging on Healthy Adult Male and Female Subjects.

This is a randomized, double-blind, comparative, two-arm, prospective, interventional, multi-centre clinical study to evaluate the safety, efficacy, and in-use tolerability of test products, standardized saffron extract capsules, on skin rejuvenation and age-defying benefits in healthy adult male and female subjects.

PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.

Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting

The goal of this clinical trial is to assess the safety and efficacy of the high-intensity focused ultrasound (HIFU) device, ULTRAFORMER MPT (UF4-M400), developed by CLASSYS Inc., for eyebrow lifting. This study is a prospective, multicenter, evaluator-blinded, randomized, non-treatment-controlled, superiority clinical trial. The main questions the study seeks to answer are: Does the ULTRAFORMER MPT device effectively lift eyebrows? Is the safety profile of the ULTRAFORMER MPT device acceptable? Researchers will compare the investigational device to a non-treatment control group to determine whether the HIFU device demonstrates superiority in eyebrow lifting outcomes. Participant Details: Participants will receive a single treatment session using the investigational device or be assigned to the non-treatment control group. Follow-up will occur over 3 months to evaluate the effectiveness and safety of the treatment. Outcomes: Primary Outcome: Eyebrow lifting improvement, assessed through standardized photographic evaluation and other aesthetic measurement tools. Secondary Outcomes: Participant satisfaction using the Global Aesthetic Improvement Scale (GAIS) and pain assessment using a Visual Analog Scale (VAS). Safety Measures: Monitoring for adverse events (AEs) and serious adverse events (SAEs) throughout the study period. This trial aims to provide robust evidence supporting the use of the ULTRAFORMER MPT for non-invasive eyebrow lifting.

Quantified Evaluation of Whole Face 8-points Supra-periosteum High Molecular Weight Hyaluronic Acid Injection in Asian

Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Hyaluronic acid (HA) is a widely used biomaterial in clinical practice, known for its excellent tissue compatibility, low risk, and safety. Previous research and clinical practice have demonstrated that HA for facial lifting can help restore facial fullness, elasticity, and promote a more youthful appearance. Dermatologist previously utilized the supra-periosteum lift technique in high molecular weight hyaluronic acid injection. It was found that the material properties of high molecular weight hyaluronic acid not only made it suitable for filling but also provided lifting support, resulting in improvements in cheek fullness and facial aging. However, there has been no detailed quantitative study on the efficacy of high molecular weight hyaluronic acid for facial lifting. To further investigate this effect, the investigators plan to conduct a prospective, open-label clinical trial. The investigators will recruit 25 adult and use an 8-point supra-periosteum facial lifting technique to inject high molecular weight hyaluronic acid. Assessments will be conducted preoperatively, postoperatively, and 4 weeks, 12 weeks and 24 weeks postoperatively to analyze the treatment efficacy. The eight injection points will be located at the brow peak, brow tail, pterion, lateral canthus, zygomatic ligament, mid-cheek, nasolabial fold, and mentalis. The investigators will use evaluation forms with four angles and six lengths, as well as the Global Aesthetic Improvement Scale, to quantify the degree of improvement in facial aging. Additionally, The investigators will use a satisfaction survey to understand subjects' perceptions of postoperative lifting effects and overall improvement satisfaction. The investigators hypothesized this study to improve facial aging in Asian patients and provide long-lasting effects.

A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles

The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.

Fractional Laser vs. Ultrasound for Periorbital Wrinkles

The primary objective of this study is to compare the efficacy of intense focused ultrasound and carbon dioxide-fractionated laser for treatment of periorbital wrinkles.