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Gene Expression Following Ultherapy® Treatment

This study is currently recruiting participants.
Verified May 2017 by Ulthera, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02441036
First Posted: May 12, 2015
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ulthera, Inc
  Purpose
Up to 15 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.

Condition Intervention
Skin Laxity Device: Ultherapy Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Changes in Gene Expression Following Ultherapy® Treatment

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Gene Expression [ Time Frame: 1-3 hours to up to 45 days following Ultherapy treatment ]

    This study will observe:

    • Apoptosis using the Polymerase Chain Reaction array to detect apoptotic genes induced; and
    • Genechip analysis to view entire gene expression.

  • Protein Production [ Time Frame: 1-3 hours to up to 45 days following Ultherapy treatment ]

    This study will observe:

    • Heatshock proteins; and
    • Immunohistochemistry analysis - Tissue sections will be stained for specific proteins expressed when genes of interest are activated or upregulated.


Estimated Enrollment: 15
Actual Study Start Date: May 1, 2015
Estimated Study Completion Date: August 31, 2017
Estimated Primary Completion Date: August 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 - 1-3 hours prior
Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.
Device: Ultherapy Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ulthera System Treatment
Active Comparator: Group 2 - 1 day prior
Subjects will receive Ultherapy treatment 1 day prior to tissue resection.
Device: Ultherapy Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ulthera System Treatment
Active Comparator: Group 3 - 3 days prior
Subjects will receive Ultherapy treatment 3 days prior to tissue resection.
Device: Ultherapy Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ulthera System Treatment
Active Comparator: Group 4 - 7 days prior
Subjects will receive Ultherapy treatment 7 days prior to tissue resection.
Device: Ultherapy Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ulthera System Treatment
Active Comparator: Group 5 - 45 days prior
Subjects will receive Ultherapy treatment 45 days prior to tissue resection.
Device: Ultherapy Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Name: Ulthera System Treatment

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441036


Locations
United States, Arizona
North Valley Plastic Surgery Terminated
Phoenix, Arizona, United States, 85050
United States, Wisconsin
Campbell Facial Plastic Surgery Recruiting
Mequon, Wisconsin, United States, 53092
Contact: Tara Davison    262-242-7772    tarad@myquintessa.com   
Principal Investigator: Andrew Campbell, MD         
Sponsors and Collaborators
Ulthera, Inc
Investigators
Study Director: Kari Larson, MBA Ulthera, Inc
  More Information

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT02441036     History of Changes
Other Study ID Numbers: ULT-140
First Submitted: May 6, 2015
First Posted: May 12, 2015
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Ulthera, Inc:
Gene expression and protein production

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases