Gene Expression Following Ultherapy® Treatment
Skin Laxity
About this trial
This is an interventional basic science trial for Skin Laxity focused on measuring Gene expression and protein production
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:
- 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;
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:
- Accutane or other systemic retinoids within the past six months;
- Topical Retinoids within the past two weeks;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Sites / Locations
- North Valley Plastic Surgery
- Campbell Facial Plastic Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Group 1 - 1-3 hours prior
Group 2 - 1 day prior
Group 3 - 3 days prior
Group 4 - 7 days prior
Group 5 - 45 days prior
Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.
Subjects will receive Ultherapy treatment 1 day prior to tissue resection.
Subjects will receive Ultherapy treatment 3 days prior to tissue resection.
Subjects will receive Ultherapy treatment 7 days prior to tissue resection.
Subjects will receive Ultherapy treatment 45 days prior to tissue resection.