Ultherapy® for Treating the Face and Neck Using Standard Versus Simulines Transducers

NCT02416076 | Completed FDA Device

• 1 other identifier: ULT-141
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

Up to 40 participants will be enrolled, randomized and treated. Enrolled participants will receive one, split-face Ulthera® treatment on the face and neck using a Ulthera System standard transducer on one side of the face and a Ulthera System prototype simulines transducers on the other side of the face. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

Skin Laxity

Keywords

Ulthera® System; Ultherapy®; Ulthera, Inc.

Outcome Measures

Primary Outcomes (1)

• Comfort level of standard transducers versus simulines transducers during Ultherapy® treatment

  Subjects' treatment-related pain scores will be obtained using a validated 0-10 point Numeric Rating Scale while study treatment is being administered. It is estimated that each study treatment will be completed in approximately 90 minutes.

  During study treatment. Participants will be followed for an average of 90 minutes.

Secondary Outcomes (6)

• Brow lift obtained using simulines versus standard transducers

  90 days post-treatment

• Brow lift obtained using simulines versus standard transducers

  180 days post-treatment

• Improvement in overall lifting and tightening of skin

  90 days post-treatment

• Improvement in overall lifting and tightening of skin

  180 days post-treatment

• Patient Satisfaction

  90 days post-treatment

Study Arms (6)

Group A - LT side simulines Ulthera treatment at EL2

ACTIVE COMPARATOR

Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at the default Energy Level \[EL2\].

Device: Ulthera Treatment at EL2

Group B - RT side simulines Ulthera treatment at EL2

ACTIVE COMPARATOR

Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at the default Energy Level \[EL2\] .

Device: Ulthera Treatment at EL2

Group C - LT side simulines Ulthera treatment at EL4

ACTIVE COMPARATOR

Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level \[EL4\].

Device: Ulthera Treatment at EL4

Group D - RT side simulines Ulthera treatment at EL4

ACTIVE COMPARATOR

Ulthera treatment using 'Ulthera System, prototype simulines transducers' on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFT side of the face at a higher Energy Level \[EL4\] .

Device: Ulthera Treatment at EL4

Group E - LT side simulines/standard Ulthera treatment at EL4

ACTIVE COMPARATOR

Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers' and 7-3.0 'Ulthera System, standard transducers' on the LEFT side of the face and 'Ulthera System, standard transducers' on the RIGHT of the face at a higher Energy Level \[EL4\].

Device: Ulthera Treatment at EL4

Group F - RT side simulines/standard Ulthera treatment at EL4

ACTIVE COMPARATOR

Ulthera treatment using a 4-4.5 'Ulthera System, prototype simulines transducers'and 7-3.0 standard transducer on the RIGHT side of the face and 'Ulthera System, standard transducers' on the LEFTof the face at a higher Energy Level \[EL4\].

Device: Ulthera Treatment at EL4

Interventions

Ulthera Treatment at EL2 DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy

Group A - LT side simulines Ulthera treatment at EL2; Group B - RT side simulines Ulthera treatment at EL2

Ulthera Treatment at EL4 DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy

Group C - LT side simulines Ulthera treatment at EL4; Group D - RT side simulines Ulthera treatment at EL4; Group E - LT side simulines/standard Ulthera treatment at EL4; Group F - RT side simulines/standard Ulthera treatment at EL4

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 30 to 65 years.
• Participant in good health.
• Skin laxity on the area(s) to be treated.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Participants 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 (example barrier methods used with a spermicidal agent, hormonal methods, intrauterine device (IUD), surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
• Postmenopausal for at least 12 months prior to study;
• Without a uterus and/or both ovaries; or
• Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other nonsteroidal anti-inflammatory drug (NSAID) prior to each study treatment and chronic use during the entire posttreatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. Washout period for limited acute NSAID use, that is, a maximum of 2-3 doses, is required in the 2 weeks prior to any study treatment visit.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (that is, removal of jewelry and makeup).
• 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.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity on the area(s) to be treated.
• Significant scarring in the area(s) to be treated.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Active implants (example, 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 two weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• BMI equal to or greater than 25.
• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (3)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

California Skin Institute - Saratoga

Saratoga, California, 95070, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: April 14, 2015
• Study Start: December 15, 2014
• Primary Completion: September 23, 2015
• Study Completion: January 1, 2016
• Last Updated: April 23, 2019

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)