Evaluation of the Ulthera® System for Treatment of the Face and Neck

NCT01713907 | Terminated

• 1 other identifier: ULT-109
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

Wrinkles; Rhytids; Skin Laxity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in facial wrinkles and lifting and tightening of skin

  Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline

  90 days post-treatment

Secondary Outcomes (2)

• Overall aesthetic improvement

  Participants will be followed up to 180 days post-treatment

• Overall patient satisfaction

  90 and 180 day post-treatment

Study Arms (1)

Ulthera® treatment

EXPERIMENTAL

All enrolled subjects will receive one full face and neck Ulthera® treatment.

Device: Ulthera® Treatment

Interventions

Ulthera® Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy™ System, Ulthera, Inc.

Ulthera® treatment

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, aged 30 to 65 years.
• Subject in good health.
• Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.
• Mild to moderate rhytids in the periorbital or perioral region.
• Mild to moderate laxity in the areas to be treated, which includes length and depth of lines.
• Mild to moderate vertical perioral lines
• Mild to moderate marionette lines.
• Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity
• Understands and accepts the obligation not to undergo any other procedures in the areas 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 on the cheek.
• Excessive skin laxity on the lower face and neck.
• Deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated.
• Excessive hooding with or without redundant skin in the areas to be treated.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, 20852, 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

Study Officials

• Hema Sundaram, MD

  Dermatology, Cosmetic & Laser Surgery

  PRINCIPAL INVESTIGATOR

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: October 15, 2012
• First Posted: October 25, 2012
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 24, 2017

Record last verified: 2013-02

Locations

US (1)