Thermage CPT for Treatment of Facial and Neck Laxity

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

Official Title
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Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity

Conditions
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Skin Aging

Intervention / Treatment
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* Device: Thermage CPT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Framed Tip<br>Treatment with Thermage CPT Framed Tip | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|
| Experimental: Pattern Tip<br>Treatment with the Thermage CPT Pattern Tip | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|
| Experimental: Pattern Tip Group 2<br>Treatment with the Thermage CPT Pattern tip | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|
| Experimental: Total Tip<br>Treatment with the Thermage CPT Total tip | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|
| Experimental: Framed and Patterned Tip<br>Split face treatment with the Thermage CPT Framed and Patterned tips | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|
| Experimental: Total and Patterned Tip<br>Split face treatment with the Thermage CPT Total and Patterned tips | Device: Thermage CPT<br>* Treatment with Thermage patterned, total, or framed tip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Laxity | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Skin Laxity (Subject Self-assessed) | 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. | 6 months | 
| Subject Satisfaction With Treatment Results | 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'). | 6 months |