Thermage CPT for Treatment of Facial and Neck Laxity

NCT01783496 | Completed Results

• 1 other identifier: 13-136-TM-T
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Improvement in Skin Laxity (Subject Self-assessed)

  6 months

• Subject Satisfaction With Treatment Results

  6 months

Study Arms (6)

Framed Tip

ACTIVE COMPARATOR

Treatment with Thermage CPT Framed Tip

Device: Thermage CPT

Pattern Tip

EXPERIMENTAL

Treatment with the Thermage CPT Pattern Tip

Device: Thermage CPT

Pattern Tip Group 2

EXPERIMENTAL

Treatment with the Thermage CPT Pattern tip

Device: Thermage CPT

Total Tip

EXPERIMENTAL

Treatment with the Thermage CPT Total tip

Device: Thermage CPT

Framed and Patterned Tip

EXPERIMENTAL

Split face treatment with the Thermage CPT Framed and Patterned tips

Device: Thermage CPT

Total and Patterned Tip

EXPERIMENTAL

Split face treatment with the Thermage CPT Total and Patterned tips

Device: Thermage CPT

Interventions

Thermage CPT DEVICE

Treatment with Thermage patterned, total, or framed tip

Framed Tip; Framed and Patterned Tip; Pattern Tip; Pattern Tip Group 2; Total Tip; Total and Patterned Tip

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valeant Pharmaceuticals: lead

Study Sites (1)

Solta Medical Aesthetic Center

Hayward, California, 94545, United States

Location

Results Point of Contact

• Title: Director of Clinical Programs
• Organization: Solta Medical

aloncaric@solta.com

510-259-5284

Study Officials

• Ronald Wheeland, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 9, 2017
• Results First Posted: November 17, 2014

Record last verified: 2017-05

Locations

US (1)