Retrospective Evaluation of Combination Treatment With the Ulthera System

Completed

• Conditions: Skin Laxity

• Registration Number: NCT02444169
• Lead Sponsor: Ulthera, Inc

Brief Summary

A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.

Detailed Description

This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Male or female, age 25 to 70 years.
• Subject in good health
• Subject must have had an Ultherapy treatment and Merz branded neurotoxin/filler treatments within 6 months of one or more Ultherapy treatments.
• Subject must have had both Ultherapy and neurotoxin/filler within the last 2 years (since April 2013) and with toxin/filler treatment within 6 months proximity to the Ultherapy treatment date.
• Absence of physical or psychological conditions unacceptable to the investigator, especially those whom are contraindicated to receive treatments with Ultherapy, Belotero, Radiesse and/or Xeomin.
• Subjects who are identified with good photography, must have the ability to be contacted to provide authorization to disclose photographs for usage of previously taken photography, if photos are deemed worthy of publication.

Exclusion Criteria

• Subjects who have had any and all Ultherapy treatment(s) before April 2013.
• Subjects who have not received Radiesse®, Xeomin®, and/or Belotero Balance® within 6 months of Ultherapy treatment date.
• Psychiatric drugs and/or diseases that in the investigators opinion would impair the subject from understanding the photo consent, if photos are chosen for publication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Within 6 months before or after Ultherapy	An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers.

Trial Locations

Locations (5)

Maryland Laser Skin and Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Skin Research Institute; 🇺🇸 Coral Gables, Florida, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Aesthetic Plastic Surgical Institute; 🇺🇸 Laguna Beach, California, United States

Dermatology Cosmetic Laser Medical Associates of La Jolla; 🇺🇸 San Diego, California, United States