27 Clinical Trials for Various Conditions
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response. Objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.
The study objective is to evaluate the safety and efficacy of a radiofrequency (RF) source, the TriActive+ RF handpiece, for treatment of wrinkles and rhytides after multiple treatments. The primary endpoint is observation of changes to the surface by visual and photographic analysis. Secondary endpoints: measurement of patient satisfaction and comfort of the treatment and the measurement of adverse events.
Non-invasive, energy-based, aesthetic treatments are becoming increasingly popular among female and male patients of all ages. Different technologies are presently available to rejuvenate skin, including therapeutic ultrasound, lasers and intense pulsed light (IPL), however radiofrequency has emerged as the most effective and versatile modality for the broadest range of body and facial treatments, including non-invasive wrinkle treatment. The apollo™ system is an RF system, based on the TriPollar™ technology. The technology is based on three or more electrodes designed to deliver RF current focused into the skin, thus generating heat in the dermal layer. Selective and focused electro-heating of the skin is intended to stimulate collagen remodeling in the dermal layer resulting in non invasive wrinkle treatment. The apollo™ system is intended for use in dermatologic and general surgical procedures for non invasive treatment of facial wrinkles and rhytides. This study was designed in order to evaluate the safety and efficacy of the Apollo™ System for facial wrinkles and rhytides treatments.
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.
Subjects with grades ranging from 1---3 on the Transverse Neck Line Scale, will be randomized to receive up to 1cc of Restylane Refyne on one side of their neck utilizing a cannula and up to 1cc of Restylane Refyne on the other side utilizing a 30--gauge needle. On Day 30, this treatment with the same left---right assignment can be repeated if optimal correction on either side has not been achieved according to the treating investigator. Subjects will return 24--48 hours after their first treatment, to fill out questionnaires, take pictures, and to be assessed by blinded evaluators regarding adverse events. Subjects will also return 30 days after their final treatment to fill out final questionnaires, take pictures, and to be assessed by blinded evaluators regarding improvement of static rhytides.
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Investigators hypothesize that regular consumption of almonds will augment the long chain fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the appearance of facial wrinkles in post-menopausal women.
This study is being done to find out if the use of botulinum toxin prior to a medium strength combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will improve the appearance of crow's feet wrinkles when compared to a chemical peel alone. Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two products/procedures have been FDA approved to improve the appearance of facial wrinkles.
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles.
Use of RF device to treat wrinkles of the neck
The goal of this study is to observe the healing of skin after ellacor® treatment at different timepoints, depths and coring densities. The visual comparison of treated areas to untreated control areas will improve understanding of how the ellacor® procedure works to induce skin resurfacing using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure. The main questions this study aims to answer are: How does human skin change after a series of the ellacor® procedures over a 14-day period? Is the ellacor® device safe to use at different treatment time points, depths and densities? The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the skin areas marked for removal during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in the study. The 3 participants will have the ellacor® procedure done at 4 different timepoints before their abdominoplasty surgery: -14 days, -7 days, -3 days and on day 0, just prior to the abdominoplasty procedure. At each treatment timepoint the participants will have 3 areas treated using a depth of 7mm and different skin removal percent settings of 5%, 7% and 8%. The participants will have photos taken of the treatment areas and will be asked about any changes to their health or medications over the 14-day study. Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated, which is the control area. This will reveal, by visual comparison, any changes in the skin tissue between treated and untreated areas, if they occur.
Open-label, non-randomized, prospective, multi-center, self-controlled
This study will assess the efficacy of Cellular MatrixTM BCT-HA Kit treatment compared to placebo condition on revitalization and skin rejuvenation on the midface. Particular attention will be made to the safety aspects, as well as the histological consequences of treatment.
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.
The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.
This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.
This is a comparison trial with novel application of AmnioFix and a control arm. Patients electively being treated with facial lasers will be assigned to receive AmnioFix in addition to the normal standard of care placed on half of their face after laser procedure, and normal post laser standard of care alone on the other half of their face. The investigators will investigate the end points of healing, recovery time, re-epitheliaziation, and other cosmetic factors. The study is designed to compare AmnioFix to the current standard of laser care.
The overall purpose of this study is to evaluate the safety and effectiveness of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.
The overall purpose of this study is to evaluate the long-term safety of repeat treatment with an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines.
The overall purpose of this study is to evaluate the safety and effectiveness of repeat treatment of an intramuscular dose of Mentor Purified Toxin for the reduction of frown lines, compared with placebo.
The goal of this study to better understand how the ellacor® Micro-Coring™ procedure works using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure. The main questions this study aims to answer are: 1. how does the ellacor® procedure change skin tissue? 2. is the ellacor® device safe to use at specific treatment depths? The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the areas marked for removal of skin during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in each of 2 groups for a total of 6 total participants. 3 participants in the first group will have the ellacor® procedure done 30 days before their abdominoplasty surgery. The ellacor® procedure will be done at different depths in designated locations: 4mm, 5mm and 7mm. The participants will be asked about any changes to their health or medications while on the study. 3 participants in the second group will have the ellacor® procedure done at 3 different timepoints, 30 days apart, all at the same depth of 4mm. They will also be asked about any changes to their health or medications while on the study. Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated. This will reveal any changes in the skin tissue between treated and untreated areas, if they occur.
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.
The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.