Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences

NCT03599349 | Completed Results FDA Device

• 1 other identifier: ULT-145
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation Points (TCPs) produced during a treatment with the Ulthera System make contact with anatomical layers of the skin and underlying tissues.

Conditions

Facial and Neck Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Determine if There is a Correlation Between D90 Quantitative Efficacy Results of the Eyebrow and Lower Face Region With Where the TCPs Produced During Ultherapy Treatment Make Contact With Anatomical Layers of the Skin and Underlying Tissues.

  TCP = Thermal Coagulation Points. The average Superficial Musculo-Aponeurotic System (SMAS) depth in the eyebrow and lower face regions (cheeks, submental and submandibular) will be compared to quantitative measurement of lift in the eyebrow and submental/neck lift at day 90 post-treatment

  Day 90 post treatment

Secondary Outcomes (8)

• Comparison of CGAIS Ratings to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation.

  Day 90 and 180 post-treatment

• The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement at Day 90 and 180 Post-treatment Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation

  Day 90 and 180 post-treatment

• Qualitative Assessment of Overall Aesthetic Improvement Will be Compared to the Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation

  Day 90 and 180 post-treatment

• The Subject Will Complete a Patient Satisfaction Questionnaire at the 90 and 180 Day Follow-up Visits Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation

  Day 90 and 180 post-treatment

• The Depth of Frontal Region Tissue Layers Will be Compared to the Quantitative Measurements of Lift in the Eyebrow Region to Determine if There is or is Not a Correlation.

  Day 90 and 180 post-treatment

Study Arms (1)

Microfocused ultrasound w/ visualization

EXPERIMENTAL

Each subject to receive a full face and neck area treatment using a standard 800 line treatment with set energy levels (0.90 joules for the 4-4.5mm transducer, 0.30 joules for the 7-3.0mm/7-3.0N transducers and 0.75 joules for the 7-4.5mm transducer)

Device: Microfocused ultrasound w/ visualization

Interventions

Microfocused ultrasound w/ visualization DEVICE

Also known as: Ultherapy

Microfocused ultrasound w/ visualization

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject in good health.
• Mild to moderate skin laxity on the area(s) to be treated.
• Subject is pre-menopausal (treated in first week of cycle) or post-menopausal.
• Subject forehead's sub-dermal layer is at least a depth of 4.5mm using the 7-4.5mm transducer.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• 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, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if the following conditions is documented on the medical history:
• a. 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 NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed i.e a maximum of 2-3 doses, in any 2 weeks period.
• 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.
• 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 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.
• 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.
• History of Hysterectomy.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

clinicaltrials@merz.com

+49 69 1503 865

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: August 20, 2015
• Primary Completion: July 13, 2016
• Study Completion: July 13, 2016
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)