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

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708512
• Other study ID #: ULT-130
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall aesthetic improvement	Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.	365 days post-treatment