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

Not Applicable

Completed

• Conditions: Skin Laxity; Wrinkles
• Interventions: Device: Ulthera System Treatment; Device: Thermage

• Registration Number: NCT01713985
• Lead Sponsor: Ulthera, Inc

Brief Summary

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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Ulthera System Treatment	Ulthera System Treatment Right, Thermage Left
Group A	Thermage	Ulthera System Treatment Right, Thermage Left
Group B	Thermage	Ulthera System Treatment Left, Thermage Right
Group B	Ulthera System Treatment	Ulthera System Treatment Left, Thermage Right

Primary Outcome Measures

Name	Time	Method
Number of Participants with Lifting and Tightening of Skin	180 days post treatment	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.
Number of Participants with Wrinkle Reduction	180 days post treatment	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FACES+; 🇺🇸 San Diego, California, United States