Simulines Non-Inferiority Pivotal Study

NCT02736825 | Terminated Results DMC

• 1 other identifier: ULT-146
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 8

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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90

  Participant response was defined as \>=20 mm\^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.

  Day 90

Secondary Outcomes (17)

• Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180

  Day 180

• Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365

  Day 365

• Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90

  Day 90

• Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180

  Day 180

• Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365

  Day 365

Study Arms (2)

Group A, Ulthera System with standard transducers

ACTIVE COMPARATOR

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

Device: Ulthera System with standard transducer

Group B, Ulthera System with prototype 2 simulines transducers

EXPERIMENTAL

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

Device: Ulthera System with prototype 2 simulines transducer

Interventions

Ulthera System with standard transducer DEVICE

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

Also known as: Ultherapy

Group A, Ulthera System with standard transducers

Ulthera System with prototype 2 simulines transducer DEVICE

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

Also known as: Ultherapy

Group B, Ulthera System with prototype 2 simulines transducers

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (8)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

Roseville Facial Plastic Surgery

Roseville, California, 95661, United States

Location

Laser and Skin Surgery Center

Sacramento, California, 95816, United States

Location

Dermatology Cosmetic Laser Medical Associates of La Jolla

San Diego, California, 92121, United States

Location

AboutSkin Dermatology

Greenwood Village, Colorado, 80111, United States

Location

Maryland Laser Skin and Vein Dermatology

Cockeysville, Maryland, 21030, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28403, United States

Location

Premier Clinical Research

Spokane, Washington, 92202, 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

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals GmbH

clinicaltrials@merz.com

+49 69 1503 1

Study Officials

• Kari Larson, MBA

  Ulthera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 13, 2016
• Study Start: April 11, 2016
• Primary Completion: January 20, 2017
• Study Completion: April 25, 2017
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)