gene expression following ultherapy® treatment

Conditions: Skin Laxity

Summary: 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.

this is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an ultherapy® treatment. subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. during an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.

Eligibility criteria:
inclusion criteria: * male or female, age 45 to 70 years. * subject in good health. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the screening visit and be willing and able to use an acceptable method of birth control during the study. * absence of physical or psychological conditions unacceptable to the investigator. * willingness to refrain from use of aspirin, ibuprofen, naproxen or any other non-steroidal anti-inflammatory drug (nsaid) prior to study treatment and chronic use during the entire post-treatment study period. * willingness and ability to provide written informed consent and health insurance portability and accountability act (hipaa) authorization prior to performance of any study-related procedure. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * significant scarring in the area(s) to be treated that would interfere with assessing results. * open wounds or lesions in the area(s) to be treated. * severe or cystic acne on the area(s) to be treated. * active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.) * inability to understand the protocol or to give informed consent. * microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study. * excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated. * bmi equal to or greater than 30. * history of chronic drug or alcohol abuse. * history of autoimmune disease. * concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device. * subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability. * concurrent enrollment in any study involving the use of investigational devices or drugs. * current smoker or history of smoking in the last five years. * current user of any nicotine-containing products, e.g., e-cigarettes, nicorette gum, nicotine patches, etc. * history of the following cosmetic treatments in the area(s) to be treated: 1. skin tightening procedure within the past year; 2. injectable filler of any type within the past: i. 12 months for hyaluronic acid fillers (e.g. restylane) ii. 12 months for ca hydroxyapatite fillers (e.g. radiesse) iii. 24 months for long-lasting hyaluronic acid (juvéderm voluma) and poly-l-lactic acid fillers (e.g. sculptra) iv. ever for permanent fillers (e.g. silicone, artefill) c. neurotoxins within the past three months; d. ablative resurfacing laser treatment within the past six months; e. nonablative, rejuvenative laser or light treatment within the past six months; f. surgical dermabrasion or deep facial peels; or g. facelifts within the past year. * history of using the following prescription medications: 1. accutane or other systemic retinoids within the past six months; 2. topical retinoids within the past two weeks; 3. antiplatelet agents/anticoagulants (coumadin, heparin, plavix); 4. psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Keywords: gene expression and protein production