Gene Expression Following Ultherapy® Treatment

Ulthera

Status: Terminated

Conditions: Skin Laxity

Treatments: Device: Ultherapy Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02441036

ULT-140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 5 patient groups

Group 1 - 1-3 hours prior

Active Comparator group

Description:

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

Treatment:

Device: Ultherapy Treatment

Group 2 - 1 day prior

Active Comparator group

Description:

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

Treatment:

Device: Ultherapy Treatment

Group 3 - 3 days prior

Active Comparator group

Description:

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

Treatment:

Device: Ultherapy Treatment

Group 4 - 7 days prior

Active Comparator group

Description:

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

Treatment:

Device: Ultherapy Treatment

Group 5 - 45 days prior

Active Comparator group

Description:

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

Treatment:

Device: Ultherapy Treatment