Thermage CPT for Treatment of Facial and Neck Laxity

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

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

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Device: Thermage CPT

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Hayward, California, United States, 94545
      • Solta Medical Aesthetic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Valeant Pharmaceuticals
• Investigators: Principal Investigator: Ronald Wheeland, MD

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 5, 2013

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 13-136-TM-T