Cutis Laxa

This research aims to evaluate the safety and effectiveness of the Thermage FLX System, a device designed to improve lines and wrinkles and lift and tighten loose skin in adults aged 30 to 60 years. The study is a prospective, randomized, multicenter trial conducted at approximately 10 sites in North America and China. It focuses on mild-to-moderate skin laxity and wrinkles on the neck, abdomen, upper arms, and face. Participants are randomly assigned to receive treatment with the Thermage FLX device either on day 1 or day 90. The study compares treated participants with an untreated control group to assess improvements in skin appearance. The treatment involves a non-invasive radiofrequency procedure designed for dermatological use. During the 6-month 26-week study, participants will attend scheduled visits for assessments by independent blinded evaluators. Researchers will measure the primary outcome at 90 days and secondary outcomes at 180 days after treatment. Safety, tolerability, and skin improvements will be closely monitored through various clinical evaluations and participant follow-up throughout the study period.

Researchers are evaluating skin changes in adult women with moderate-to-severe cheek wrinkles using non-invasive imaging methods. The goal is to study the effects of treatments aimed at improving volume deficiency, skin laxity, and photo-aged skin in the mid-face area. This is an open-label, single-center study sponsored by Galderma R&D involving women aged 45 to 65 years. Participants will receive three treatments of Sculptra injections into the cheeks, spaced four weeks apart. Each treatment involves subdermal injections using a 25 G needle, with up to 18 mL total per session. The injections target the subcutaneous and supraperiosteal regions evenly across both cheeks. The study focuses on monitoring structural skin changes following these biostimulator treatments. During the study, participants will undergo standardized VISIA imaging and optical biopsy imaging at multiple time points 4, 8, 12, 16, and 20 weeks after baseline. Researchers will assess changes in the midface structure compared to before treatment. Participants must adhere to a skincare regimen provided by the study and allow photographs at each visit. Safety and response will be monitored throughout the study period, which runs until September 2026.

Researchers are evaluating the potential of a new technique called Brillouin microscopy to diagnose corneal conditions such as keratoconus and ectasia. The study compares the biomechanical properties of corneas in people with keratoconus, those with post-LASIK ectasia, and individuals with normal corneas. This observational study aims to better understand differences in corneal tissue using this advanced imaging method. Participants include volunteers with normal corneas, patients diagnosed with various stages of keratoconus, individuals who had LASIK surgery with or without complications, people scheduled for PRK or LASIK surgery, and patients with Fuchs endothelial corneal dystrophy. The study involves axial scans of the cornea using Brillouin imaging to assess and compare corneal biomechanics across these groups. Specific inclusion and exclusion criteria apply to each group based on diagnosis, prior surgeries, and other eye health factors. During the study, participants undergo corneal imaging to measure the corneas elastic modulus, reflecting its biomechanical properties. Researchers monitor these properties over time to evaluate the diagnostic capabilities of Brillouin microscopy. Participants will be assessed for corneal health through topography, pachymetry, and clinical evaluations, with the study lasting several years to gather comprehensive data. The research team also excludes individuals unable to understand imaging instructions or with certain eye conditions to ensure accurate measurements.

Researchers are evaluating Autologous Adipose Cell Therapy to improve skin rejuvenation and hair restoration. This therapy aims to overcome the limitations of traditional fat grafting and dermal fillers by isolating early-stage fat cells for better distribution and longer-lasting effects. The study focuses on assessing the safety, feasibility, and effectiveness of this therapy for conditions like wrinkles, fine lines, skin elasticity loss, pigmentation, hair thinning, and hair loss. Participants will receive the Autologous Adipose Cells therapy treatment, which involves processing fat cells from their own body to enhance skin and hair appearance. The therapy is monitored by the primary investigator for up to 25 weeks to evaluate outcomes. This study includes only one treatment group receiving this biological intervention. During the study, participants will undergo various assessments including imaging, satisfaction surveys, and evaluation reports from the first visit before treatment through the last follow-up visit between weeks 16 and 25. The plastic surgeon will monitor treatment effects and safety over a six-month period. The total involvement spans from initial treatment to multiple follow-ups to track skin and hair improvements and participant satisfaction.

Researchers are evaluating the effects of bovine and marine collagen supplements compared to a placebo on skin, hair, nails, and overall body health in healthy adult women aged 35 to 55 years. This randomized controlled trial, called the BECOME Study, aims to find which type of collagen is most effective at improving outcomes such as skin elasticity, nail strength, hair thickness, and other health markers related to skin and whole body wellness. Participants will take 10 grams of either bovine collagen, marine collagen, or a placebo powder daily throughout the study period. The study includes three groups receiving these supplements to compare their effects directly. The intervention lasts for 12 weeks, with assessments at the start, week 6, and week 12. During the study, participants will be evaluated on changes in nail growth and strength, skin elasticity and wrinkles, hair thickness and strength, skin pigmentation, and hydration. Subjective assessments of skin health and digestive quality of life will also be collected at baseline and follow-up visits. The trial includes safety monitoring and aims to capture both objective and personal perceptions of health improvements over the 12-week period.

Researchers are studying a new polynucleotide-based soft-tissue filler called PN30 RDM16 designed to improve skin hydration, elasticity, and turgor. This clinical investigation is a pre-market, two-stage, single-arm trial to evaluate both the safety and performance of PN30, a product developed using High Purification Technology Polynucleotides PN HPTTM. These polynucleotides are natural substances with moisturizing and viscoelastic properties, intended to act as temporary fillers that enhance skin appearance by increasing hydration and firmness. The study involves administering PN30 via intradermal injections in a single treatment arm. PN30 is provided as a sterile, viscoelastic gel in prefilled syringes, containing 3% polynucleotides derived from natural fish origin. The investigation is adaptive with two stages Stage I focuses on safety assessment through skin examination and monitoring of device-related events, while Stage II evaluates the products aesthetic performance using various skin assessment tools. Participants will undergo injections and attend scheduled visits over approximately 12 weeks, during which researchers will assess skin reactions, hydration, elasticity, turgor, and patient satisfaction. Tools used include the Global Aesthetic Improvement Scale GAIS, MoistureMeterEpiD, ElastiMeter, and pain rating scales. Safety monitoring will continue through adverse event tracking and device deficiency checks. Participants must follow study guidelines regarding cosmetic use and sun exposure throughout the trial.

Researchers are evaluating the Ulthera System to improve skin laxity in the lower face, submental area, and neck of adults aged 35 to 65 years. The study aims to show that treatment with the Ulthera System is better than no treatment and to assess its safety for these areas. Participants have mild to moderate skin laxity that can be improved without surgery. Participants are randomly assigned to one of two groups. One group receives a single treatment with the Ulthera System to the lower face, submental area, and neck on the first day. The other group remains untreated for 90 days before receiving the same single treatment. The device includes a control unit, handpiece, and interchangeable transducers. This design allows comparison between immediate and delayed treatment effects. During the study, participants are monitored for changes in skin laxity at 90 days compared to baseline using a Global Aesthetic Improvement Scale assessed by blinded evaluators, investigators, and the participants themselves. Researchers collect photographs and evaluate skin improvement. Participants need to avoid other aesthetic treatments and certain medications during the study. The total study duration includes treatment and evaluation up to day 90, with safety and effectiveness closely observed.

Researchers are evaluating Quantum, a fully internal bipolar radiofrequency probe, to study its safety and effectiveness in reducing prominent skin laxity among adult patients undergoing High-Definition HD Liposculpture. This prospective interventional study also explores whether factors like age, gender, and skin phototype affect the treatments success in making skin appear more toned and youthful. In this study, all participants will undergo standardized HD Liposculpture followed by the use of the Quantum device. The device is inserted through the same incisions used during liposculpture and delivers radiofrequency energy in a controlled grid pattern across the treated area. Energy is applied at specific settings 15 J, pulse mode 3.0 pps to evenly treat both superficial and deep skin layers. Follow-up periods include immediate post-treatment and assessments at 1, 3, and 6 months after the procedure. Participants will be evaluated before and after treatment using an Elastometer to measure skin elasticity, viscoelasticity, and time to skin retraction. Data on demographics, clinical variables, surgical parameters, blood markers, complications, and patient satisfaction via the Global Aesthetic Improvement Scale will be collected securely. Photographs will document changes at baseline and during follow-ups up to 6 months. The study involves a total participation duration of 6 months with ongoing safety and effectiveness monitoring.

Researchers are evaluating the Ellacor4 Micro-Coring Technology4 device in people with Fitzpatrick Skin Types I through VI, including those taking GLP-1 receptor agonists, a type of medication that helps control blood sugar and supports weight loss. The study aims to understand how the device works on different skin types and treatment areas, and to observe any changes in treated skin compared to untreated skin. Side effects related to this treatment will also be monitored. Wrinkle severity reduction will be measured using standardized 2D imaging techniques. The device uses hollow coring needles to remove tiny, full-thickness skin cores about 0.4 millimeters wide, which is larger than standard microneedling that only punctures without removing tissue. The skin removal is small enough to avoid visible scarring. After treatment, the skin repairs itself by producing new collagen and elastin fibers. Participants will receive the same number of Ellacor4 treatments during the study, which lasts up to 90 days. Study visits include an initial screening and enrollment visit, one treatment visit, and four follow-up visits on Days 3, 7, 30, and 90, with an optional additional follow-up if needed. Participants will attend at least six visits lasting 30 to 90 minutes each. Assessments include imaging to quantify wrinkle reduction and monitoring for safety and side effects. Participation ends after the Day 90 follow-up. The study will include 10 to 30 people, all treated at one center. Participants may have their screening and treatment visits on the same day, with total study involvement lasting about three months.

Researchers are evaluating the safety and effectiveness of a fractional ablative laser device for treating skin laxity and tightening. The study aims to assess how well this laser treatment works in improving skin appearance, particularly focusing on wrinkle reduction. This pilot evaluation is sponsored by Sciton and includes adults aged 18 to 85 years with visible skin laxity or scars. Participants will receive fractional ablative laser treatment targeted at areas with skin laxity. The study involves a single treatment arm where this device is applied to improve skin tightness. There are no placebo or comparison groups, and the treatment details focus on applying the laser to affected skin regions. During the study, participants will have digital images and measurements taken of the treated area to monitor changes over time. Researchers will track wrinkle improvement for up to six months after the final treatment. Participants must follow treatment and follow-up schedules, including post-treatment care instructions. The total study duration and additional monitoring details are not specified but include these outcome assessments and safety observations.