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

Not Applicable

Completed

• Conditions: Skin Laxity
• Interventions: Device: Ulthera System Treatment

• Registration Number: NCT01708252
• Lead Sponsor: Ulthera, Inc

Brief 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-07
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulthera treatment group	Ulthera System Treatment	All subjects will receive an Ulthera System Treatment

Primary Outcome Measures

Name	Time	Method
Improvement in lower face and neck skin laxity	90 days post-treatment	Efficacy will be assessed using the 90-day images compared to baseline
Cervicomental angle	90 days post-treatment	Efficacy will be assessed using the 90-day images compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	90 days post-treatment	Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
Pain Assessment	Treatment visit	Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
Patient Satisfaction	180 days post-treatment	Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
Overall aesthetic improvement	180 days post-treatment	Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.

Trial Locations

Locations (1)

DeNova Research; 🇺🇸 Chicago, Illinois, United States