Treatment of the Face and Neck With Lower Ulthera System Energy Settings

NCT01713998 | Completed Results

• 1 other identifier: ULT-300
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. 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™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (2)

• Subjects' Assessment of Pain During Treatment With Lower Energy Settings

  Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.

  Participants were assessed for the duration of study treatment, an average of 75 minutes

• Overall Improvement in Skin Laxity on the Face and Neck

  A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.

  90 days post-treatment

Secondary Outcomes (3)

• Quantitative Assessment of Brow Lift at 90 Days Post-treatment

  90 days post-treatment

• Subject Assessment of Improvement at 90 Days Post-treatment

  90 days post-treatment

• Subject Assessment of Improvement at 180 Days Post-treatment

  180 days post-treatment

Study Arms (3)

Group A

ACTIVE COMPARATOR

Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.

Device: Ulthera System Treatment

Group B

ACTIVE COMPARATOR

Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.

Device: Ulthera System Treatment

Group C

ACTIVE COMPARATOR

Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Group A; Group B; Group C

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.
• Subject in good health.
• Skin laxity on the face and neck

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 face or neck.
• Excessive skin laxity on the face or neck.
• Significant scarring in areas to be treated.
• Open wounds or lesions in the area to be treated.
• Severe or cystic acne on the area to be treated.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Ulthera, Inc.

Mesa, Arizona, 85210, 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

clinicaltrials@merz.com

Study Officials

• Steven H Gitt, MD

  Ulthera, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 25, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2017
• Results First Posted: February 21, 2014

Record last verified: 2017-11

Locations

US (1)