Gene Expression Following Ultherapy® Treatment

Stopped early · Not applicable

Conditions studied: Skin Laxity

In brief

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.

Key facts

Study ID

NCT02441036

Run by

Ulthera, Inc

People needed

16

Starts

2015-05-01

Expected to finish

2016-08-18

Last updated by the study team

2019-02-20

Who can join

Age: 45 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Skin tightening procedure within the past year;
• 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;

Where it is running

• North Valley Plastic Surgery — Phoenix, Arizona, United States
• Campbell Facial Plastic Surgery — Mequon, Wisconsin, United States

Full record on ClinicalTrials.gov

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