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Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment | Clinical Trials | Clareo Health

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Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment

NCT01708252•Ulthera, Inc

View on ClinicalTrials.gov

Summary

Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.

Detailed Description

This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Eligibility

Age

30 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female, age 30 to 65 years.
•Subject in good health.
•BMI \< 30.
•Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
•Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
•Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.

Exclusion Criteria

•Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
•Presence of an active systemic or local skin disease that may affect wound healing.
•Severe solar elastosis.
•Excessive subcutaneous fat on the cheeks.
•Excessive skin laxity on the lower face and neck
•Significant scarring in areas to be treated.
•Open wounds or lesions in the area to be treated.
•Severe or cystic acne on the area to be treated

Locations (1)

DeNova Research

Chicago, Illinois, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

April 1, 2012

Completion Date

August 1, 2012

Last Updated

November 24, 2017

Enrollment

ACTUAL participants

Conditions

Skin Laxity

Interventions

Ulthera System Treatment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

Inclusion Criteria

Exclusion Criteria

An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity

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