Gene Expression Following Ultherapy® Treatment

NCT ID: NCT02441036

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-01
• Study Completion Date: 2016-08-18

Brief 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.

Detailed Description

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.

Conditions

Skin Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Group 1 - 1-3 hours prior

Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.

Group Type: ACTIVE_COMPARATOR

Ultherapy Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Group 2 - 1 day prior

Subjects will receive Ultherapy treatment 1 day prior to tissue resection.

Group Type: ACTIVE_COMPARATOR

Ultherapy Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Group 3 - 3 days prior

Subjects will receive Ultherapy treatment 3 days prior to tissue resection.

Group Type: ACTIVE_COMPARATOR

Ultherapy Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Group 4 - 7 days prior

Subjects will receive Ultherapy treatment 7 days prior to tissue resection.

Group Type: ACTIVE_COMPARATOR

Ultherapy Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Group 5 - 45 days prior

Subjects will receive Ultherapy treatment 45 days prior to tissue resection.

Group Type: ACTIVE_COMPARATOR

Ultherapy Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Interventions

Ultherapy Treatment

Focused ultrasound energy delivered below the surface of the skin.

Intervention Type: DEVICE

Other Intervention Names

Ulthera System Treatment

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Larson, MBA

Role: STUDY_DIRECTOR

Ulthera, Inc

Locations

North Valley Plastic Surgery

Phoenix, Arizona, United States

Campbell Facial Plastic Surgery

Mequon, Wisconsin, United States

Countries

United States

Other Identifiers

ULT-140

Identifier Type: -

Identifier Source: org_study_id