Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck

Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Study Overview

• Status: Completed
• Conditions: Wrinkles; Skin Laxity
• Intervention / Treatment: Device: Ulthera System Treatment; Device: Thermage

Detailed Description

This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • FACES+

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, age 30 to 65 years.
• Subject in good health.
• Skin laxity on the area(s) to be treated.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat in the area(s) to be treated.
• Excessive skin laxity on the area(s) to be treated.
• Significant scarring in the area(s) to be treated.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Presence of a metal stent or implant in the area(s) to be treated.
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
• Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• BMI equal to or greater than 25.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Ulthera System Treatment Right, Thermage Left	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ultherapy™; Device: Thermage; Radiofrequency treatment focusing radiofrequency energy
Active Comparator: Group B; Ulthera System Treatment Left, Thermage Right	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ultherapy™; Device: Thermage; Radiofrequency treatment focusing radiofrequency energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Lifting and Tightening of Skin	Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.	180 days post treatment
Number of Participants with Wrinkle Reduction	Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system	180 days post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Eyebrow Lift	Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.	90 days post-treatment
Number of Participants with Lower face and Neck Lift	Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.	90 days post-treatment
Number of Participants Reporting Treatment Satisfaction	Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.	180 days post-treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Steven Cohen, MD, FACES+

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: ULT-135