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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: 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: 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: NCT01713998 Completed - Skin Laxity Clinical Trials

Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Start date: September 2011
Phase: N/A
Study type: Interventional

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. 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: NCT01713985 Completed - Skin Laxity Clinical Trials

Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

Start date: September 2012
Phase: N/A
Study type: Interventional

Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. 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: NCT01708928 Completed - Skin Laxity Clinical Trials

Feasibility Study: Lifting and Tightening Neck Skin in Patients

Start date: August 2010
Phase: N/A
Study type: Interventional

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.