Thermage CPT for Treatment of Facial and Neck Laxity

Skin Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783496
• Other study ID #: 13-136-TM-T
• Status: Completed
• Phase: N/A
• First received: January 31, 2013
• Last updated: November 7, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: Valeant Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

Device:
• Thermage CPT
Treatment with Thermage patterned, total, or framed tip

Locations

Country	Name	City	State
United States	Solta Medical Aesthetic Center	Hayward	California

Sponsors (1)

Lead Sponsor	Collaborator
Solta Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No