A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

NCT01519934 | Completed Results

• 1 other identifier: ULT-120
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.

Conditions

Skin Laxity; Wrinkles

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (1)

• Improvement in Overall Lifting and Tightening of the Skin

  Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.

  Baseline to 180 days post-treatment

Secondary Outcomes (3)

• Overall Aesthetic Improvement

  Baseline to 180 days post-treatment

• Subject Perception of Age

  Baseline to 180 days post-treatment

• Patient Satisfaction

  180 days post-treatment

Study Arms (1)

Ulthera-treated subjects

All enrolled subjects will have received an Ulthera treatment prior to enrollment.

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of males and females from the investigator's practice between 25 and 85 years of age, who have received an Ultherapy™ treatment on or prior to October 1, 2011, who had pre-treatment baseline photographs taken, and who have chosen to participate in this clinical trial.

You may qualify if:

• Male or female, age 25-85 years.
• Subject in good health.
• Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
• Absence of physical or psychological conditions unacceptable to the investigator.

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Significant scarring in areas treated.
• Open wounds or lesions in the areas treated.
• Severe or cystic acne on the areas treated.
• Inability to understand the protocol or to give informed consent.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Dermatology Cosmetic Laser Associates

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Cutis Laxa

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

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Mitchel Goldman, MD

  Dermatology Cosmetic Laser Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: January 27, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 18, 2017
• Results First Posted: April 23, 2014

Record last verified: 2017-11

Locations

US (1)