NCT02444169

Retrospective Evaluation of Combination Treatment With the Ulthera System

Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Ultherapy	Focused ultrasound energy delivered below the surface of the skin.
DRUG	Incobotulinumtoxin A	An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.
DEVICE	Radiesse	An injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth).
DEVICE	Belotero Balance	An injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-05-14
• Last updated: 2017-11-24

Locations

5 sites across 1 country: United States