Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck

NCT01708512 | Completed

• 1 other identifier: ULT-130
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.

Conditions

Skin Laxity

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (1)

• Improvement in overall lifting and tightening of the skin

  As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.

  90 days post-treatment

Secondary Outcomes (1)

• Overall aesthetic improvement

  365 days post-treatment

Study Arms (1)

Ultherapy™ study treatment

EXPERIMENTAL

Each subject will receive a customized, high-density, vectored Ulthera System Treatment.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Ultherapy™ study treatment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 25 to 60 years.
• Subject in good health.
• Skin laxity in the area(s) to be treated.
• Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.

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 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.
• Presence of a metal stent or implant in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• BMI equal to and greater than 30.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• Werschler WP, Werschler PS. Long-term Efficacy of Micro-focused Ultrasound with Visualization for Lifting and Tightening Lax Facial and Neck Skin Using a Customized Vectoring Treatment Method. J Clin Aesthet Dermatol. 2016 Feb;9(2):27-33.

  PMID: 27047630 DERIVED

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

• William P Werschler, MD

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: November 24, 2017

Record last verified: 2013-09

Locations

US (1)