Simulines Non-Inferiority Pivotal Study

NCT ID: NCT02736825

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2017-04-25

Brief Summary

Up to 260 subjects presenting with skin laxity on the face and neck will be randomized to one of two treatment groups. Subjects meeting all entrance criteria will receive study treatment, then complete two post treatment phone contacts and follow-up study visits at 90, 180 and 365 days post treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit for qualitative and quantitative assessments of efficacy.

Detailed Description

This is a prospective, randomized, double blinded, multi-center, parallel arm, non-inferiority, pivotal clinical trial to demonstrate the efficacy of the Ultherapy treatment with prototype 2 simulines transducers (4-3.0 Smm and 4-4.5 Smm) at energy level (EL) 2 is non-inferior to treatment with standard transducers (7-3.0 mm and 4-4.5mm) at EL 2 for lifting the lower face and neck and to demonstrate the safety of treatment with prototype 2 simulines transducers is similar to treatment with standard transducers.

Changes from baseline in quantitative measures of neck and submental lift will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores, Merz Jawline Grading Scale scores, 3D volumetric changes from baseline to post treatment, patient satisfaction and patient-reported improvement will be obtained.

Conditions

Skin Laxity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A, Ulthera System with standard transducers

Subjects randomized to Group A will receive an Ultherapy® treatment to the lower face and neck with a total minimum pulse count of 672 pulses (+5%) at the 4.5mm and 3.0mm depths using standard transducers. Energy levels for each transducer will be set to EL2:

• Deep-See (DS) 4-4.5 at 0.9 Joules (J) with pitch of 1.5mm and 17 Thermal Coagulation Points (TCP)s per line
• DS 7-3.0 at 0.30J with pitch of 1.1mm and 23 TCPs per line

Group Type: ACTIVE_COMPARATOR

Ulthera System with standard transducer

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time

Group B, Ulthera System with prototype 2 simulines transducers

Subjects randomized to Group B will receive a Ultherapy® treatment with a total minimum pulse count of 336 pulses (+5%) using the prototype 2 simulines transducers at the 4.5mm and 3.0mm depths. Energy levels for each transducer will be set to EL2:

• Deep-See 4-4.5 Simulines (DS 4-4.5S) at 1.23J with pitch of 1.5mm and 17 TCPs per line
• DS 4-3.0S at 0.88J with pitch of 1.3mm and 20 TCPs per line

Group Type: EXPERIMENTAL

Ulthera System with prototype 2 simulines transducer

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously

Interventions

Ulthera System with standard transducer

Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time

Intervention Type: DEVICE

Ulthera System with prototype 2 simulines transducer

Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously

Intervention Type: DEVICE

Other Intervention Names

Ultherapy; Ultherapy

Eligibility Criteria

Inclusion Criteria

• Male or female, age 30 to 70 years.
• Subject in good health.
• Body Mass Index (BMI) of ≤30.
• Skin laxity in the area(s) to be treated as determined by trained physician assessors.
• Willingness to avoid excessive or prolonged exposure to sunlight, tanning booths, sun lamps, or ultraviolet (UV) light sources.
• Willingness to apply study provided sunscreen (Neocutis Micro-Day Rejuvenating Cream) daily until study exit to help limit sun exposure.
• Willingness to avoid or periodically stop use of Sunless Tanners (washout period of two weeks prior to each study visit is required).
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
• Willingness to avoid non-emergent dental procedures in the 3 weeks prior to/ post treatment.
• 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 (e.g. 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:

a. Postmenopausal for at least 12 months prior to study; b. Without a uterus and/or both ovaries; or c. 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 non-steroidal anti-inflammatory drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the study treatment. After study treatment is completed, limited acute NSAID use, i.e., a maximum of 2-3 doses in any 2 week period, is allowed if needed.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
• Willingness and ability to provide written informed consent and 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.
• History of Bell's Palsy.
• History of chronic or frequently recurring episodic (recurrent episode in past 12 months) autoimmune diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, Myasthenia Gravis, Lambert-Eaton Syndrome that has required immune suppressant therapy (such as biologic drug or corticosteroid treatment).
• Palpable thyroid lesion, lymphadenopathy, or other pathological changes within the treatment area.
• History of skin cancer in the areas to be treated, basal cell nevus syndrome, or jaw cysts.
• Known allergy or sensitivity to Ibuprofen.
• Severe solar elastosis.
• BMI > 30.
• Significant changes in weight (e.g. more than 5 pounds) over the past 6 months or anticipated significant changes in weight or diet over the course of the study.
• Pregnant within the past year.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity in the area(s) to be treated as determined by trained physician assessors.
• 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 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.
• History of chronic drug or alcohol abuse.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• 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. Any energy based device (radio-frequency (RF), micro-focused ultrasound (MFU), etc.) procedure for skin tightening 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 Hydroxylapatite fillers (e.g. Radiesse)

iii. 24 months for Long Lasting Hyaluronic acid (e.g. Voluma) and Poly-L-Lactic acid fillers (e.g. Sculptra)

iv. Ever for permanent fillers (e.g. Silicone, ArteFill)

c. Neurotoxins within the past six months (neuromodulators are allowed in the glabella and forehead, not allowed in the temples, crow's fee or anywhere below the lateral canthus);

d. Fractional and fully ablative resurfacing laser treatment within the past two years;

e. Nonablative, rejuvenative laser or light treatment within the past six months;

f. Surgical dermabrasion or deep facial peels within the past two years;

g. Facelifts, neck surgery (e.g. thyroid, neck lifts, neck liposuction, etc.) within the past two years;

h. Micro needling within the past year;

i. Kybella, Coolsculpting, or Mesotherapy within the past two years; or

j. Any history of contour threads.

• History (in the prior year) or current use of the following prescription medications:

1. Accutane or other systemic retinoids within the past six months;

2. Initiation of topical retinoids within the past 6 months or throughout the course of the study;

3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix);

4. Systemic steroids including prednisone;

5. Dermal regulators of collagen;

6. Initiation of bioidentical hormones or human growth hormone (HGH) within the past 6 months or throughout the course of the study; or

7. 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: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kari Larson, MBA

Role: STUDY_DIRECTOR

Ulthera, Inc

Locations

Clinical Testing of Beverly Hills

Beverly Hills, California, United States

Roseville Facial Plastic Surgery

Roseville, California, United States

Laser and Skin Surgery Center

Sacramento, California, United States

Dermatology Cosmetic Laser Medical Associates of La Jolla

San Diego, California, United States

AboutSkin Dermatology

Greenwood Village, Colorado, United States

Maryland Laser Skin and Vein Dermatology

Cockeysville, Maryland, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Premier Clinical Research

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ULT-146

Identifier Type: -

Identifier Source: org_study_id