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Cutis Laxa clinical trials

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NCT ID: NCT03228641 Completed - Wrinkle Clinical Trials

Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity

AIS
Start date: June 1, 2016
Phase: N/A
Study type: Interventional

A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).

NCT ID: NCT02832674 Completed - Skin Laxity Clinical Trials

Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift

Start date: June 25, 2016
Phase: N/A
Study type: Interventional

A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits. All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters. Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.

NCT ID: NCT02830776 Completed - Dermatochalasis Clinical Trials

Topical Bimatoprost for Chemical Blepharoplasty

Start date: November 2016
Phase: Early Phase 1
Study type: Interventional

Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may provide a metered effect on the periocular tissues and allow for a topical approach to periocular rejuvenation. This is a proof of concept study which aims to enroll a series of patients with mild to severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid margin, and evaluate for cosmetic improvement of the periocular area.

NCT ID: NCT02770287 Completed - Skin Laxity Clinical Trials

Radiofrequency and Pulsed Electromagnetic Field Treatment of Skin Laxity of the Mon Pubis, Labia and Vaginal Introitus

Start date: March 26, 2016
Phase: N/A
Study type: Interventional

The study will confirm that the Freeze Diamond polar applicator is safe for treating the Mons pubis and Labia, and will result in improvement in general skin appearance including an improvement in skin irregularities and skin laxity.

NCT ID: NCT02763306 Completed - Skin Laxity Clinical Trials

Dermal Cryotherapy in Patients Undergoing Abdominoplasty

Start date: June 2015
Phase: N/A
Study type: Interventional

A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

NCT ID: NCT02736825 Terminated - Skin Laxity Clinical Trials

Simulines Non-Inferiority Pivotal Study

Start date: April 11, 2016
Phase: N/A
Study type: Interventional

Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

NCT ID: NCT02444169 Completed - Skin Laxity Clinical Trials

Retrospective Evaluation of Combination Treatment With the Ulthera System

Start date: April 2015
Phase: N/A
Study type: Observational

A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.

NCT ID: NCT02441036 Terminated - Skin Laxity Clinical Trials

Gene Expression Following Ultherapy® Treatment

Start date: May 1, 2015
Phase: N/A
Study type: Interventional

Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.

NCT ID: NCT02416076 Completed - Skin Laxity Clinical Trials

Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

Start date: December 15, 2014
Phase: N/A
Study type: Interventional

Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

NCT ID: NCT01735929 Withdrawn - Skin Laxity Clinical Trials

Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.