Retrospective Evaluation of Combination Treatment With the Ulthera System

NCT02444169 | Completed

• 1 other identifier: ULT-144
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 5

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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers.

  Within 6 months before or after Ultherapy

Interventions

Ultherapy DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ulthera System Treatment

Incobotulinumtoxin A DRUG

An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.

Also known as: Xeomin

Radiesse DEVICE

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).

Also known as: Volumizing filler

Belotero Balance DEVICE

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).

Also known as: Dermal filler

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults between 25 and 70 years of age who have received an Ultherapy treatment and toxin/filler within the last two years within six months apart and meet the inclusion/exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (5)

Aesthetic Plastic Surgical Institute

Laguna Beach, California, 92651, United States

Location

Dermatology Cosmetic Laser Medical Associates of La Jolla

San Diego, California, 92121, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Liss Misell, PhD

  Ulthera, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 24, 2017

Record last verified: 2015-08

Locations

US (5)