Thermage CPT for Treatment of Facial and Neck Laxity

Not Applicable

Completed

Brief Summary: The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.

Recruitment & Eligibility

Inclusion Criteria

25 - 65 years of age
Moderate facial and neck laxity
Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Exclusion Criteria

Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
Pacemaker, internal defibrillator, or other implanted electronic device
Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.

Arm && Interventions

Group	Intervention	Description
Pattern Tip	Thermage CPT	Treatment with the Thermage CPT Pattern Tip
Total Tip	Thermage CPT	Treatment with the Thermage CPT Total tip
Framed Tip	Thermage CPT	Treatment with Thermage CPT Framed Tip
Total and Patterned Tip	Thermage CPT	Split face treatment with the Thermage CPT Total and Patterned tips
Pattern Tip Group 2	Thermage CPT	Treatment with the Thermage CPT Pattern tip
Framed and Patterned Tip	Thermage CPT	Split face treatment with the Thermage CPT Framed and Patterned tips

Primary Outcome Measures

Name	Time	Method
Improvement in Laxity	6 months	Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.

Secondary Outcome Measures

Name	Time	Method
Improvement in Skin Laxity (Subject Self-assessed)	6 months	Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.
Subject Satisfaction With Treatment Results	6 months	subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 - Very Satisfied, 4 - Satisfied, 3 - Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 - Very Dissatisfied. Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').