Clinical trial NCT02444169: Retrospective Evaluation of Combination Treatment With the Ulthera System
Official title: Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Laxity
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 101
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Within 6 months before or after Ultherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Beach
country: United States
facility: Aesthetic Plastic Surgical Institute
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein Institute
state: Maryland
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Ulthera, Inc
name: Liss Misell, PhD
role: STUDY_DIRECTOR
References: