Retrospective Evaluation of Combination Treatment With the Ulthera System

Skin Laxity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444169
• Other study ID #: ULT-144
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: November 21, 2017
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Skin Research Institute	Coral Gables	Florida
United States	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland
United States	Aesthetic Plastic Surgical Institute	Laguna Beach	California
United States	Dermatology Cosmetic Laser Medical Associates of La Jolla	San Diego	California
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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