Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708499
• Other study ID #: ULT-128
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: March 2012
• Est. completion date: April 2013

Study information

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

Clinical Trial Summary

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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.

Description:

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• 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 abdomen

• Understands and accepts the obligation not to undergo any other procedures in the areas 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 abdomen.

• Excessive skin laxity on the abdomen.

• Significant scarring in areas to be treated.

• Open wounds or lesions in the area 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 Crepiness
• Skin Laxity

Intervention

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

Locations

Country	Name	City	State
United States	Sasaki Advanced Aesthetic Medical Center	Pasadena	California

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 laxity/crepiness and texture of abdominal tissue	Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline	90 days post-treatment
Secondary	Overall aesthetic improvement	The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.	180 days post-treatment