Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

NCT01368835 | Completed Results DMC

• 1 other identifier: ULT-106
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

Conditions

Mild to Moderate Skin Laxity on Cheek; Mild to Moderate Skin Laxity on Upper Neck; Mild to Moderate Subcutaneous Fat on Cheek; Mild to Moderate Subcutaneous Fat on Upper Neck

Outcome Measures

Primary Outcomes (1)

• Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.

  The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.

  90D

Secondary Outcomes (2)

• Change in Submental and Neck Skin Laxity by Quantitative Analysis

  90D

• Patient Satisfaction Questionnaire

  90D

Other Outcomes (1)

• Subject Assessment of Pain

  During Ulthera study treatment

Study Arms (1)

Ulthera treatment

EXPERIMENTAL

Device: Ulthera treatment

Interventions

Ulthera treatment DEVICE

treatment of cheeks and upper neck area of face

Ulthera treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 35 to 60 years
• Subject in good health
• Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

You may not qualify if:

• Pregnant or lactating
• Has an active systemic or local skin disease that may alter wound healing
• Severe solar elastosis
• Excessive subcutaneous fat on the cheeks
• Excessive skin laxity on the lower face and neck
• Has significant scarring in areas to be treated
• Has significant open facial wounds or lesions
• Has severe or cystic acne on the face

Sponsors & Collaborators

• Ulthera, Inc: lead
• University of Texas Southwestern Medical Center: collaborator

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Jeffrey M. Kenkel, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: June 6, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 13, 2017
• Results First Posted: August 15, 2013

Record last verified: 2014-01