Feasibility Study: Lifting and Tightening of the Elbows

Ulthera, Inc21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Laxity

Interventions

Ulthera System TreatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New York Cosmetic, Skin and Laser Surgery Center

New York, New York, United States

Outcomes

Primary Outcomes

Overall improvement of skin laxity in the areas treated

Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.

Time frame: 90 days post-treatment

Secondary Outcomes

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.

Time frame: 90 and 180 days post-treatment

Data from ClinicalTrials.gov

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