Feasibility Study: Lifting and Tightening of the Elbows

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708382
• Other study ID #: ULT-108
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: November 21, 2017
• Start date: September 2011
• Est. completion date: February 2013

Study information

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

Clinical Trial Summary

Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. 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 to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female, age 21 to 65 years.

• Subject in good health.

• Mild to moderate skin laxity on the elbows.

• 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.

• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.

• Excessive subcutaneous fat around the elbows.

• Excessive skin laxity around the elbows.

• Significant scarring in areas to be treated.

• Significant open wounds or lesions in the area to be treated

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	New York Cosmetic, Skin and Laser Surgery Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall improvement of skin laxity in the areas treated	Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.	90 days post-treatment
Secondary	Aesthetic improvement	GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.	90 and 180 days post-treatment