Thermage CPT for Treatment of Facial and Neck Laxity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solta Medical
ClinicalTrials.gov Identifier:
NCT01783496
First received: January 31, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Skin Aging
Device: Thermage CPT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity

Resource links provided by NLM:


Further study details as provided by Solta Medical:

Primary Outcome Measures:
  • Improvement in Laxity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in facial and neck laxity 6 months following treatment.


Enrollment: 50
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Framed Tip
Treatment with Thermage CPT Framed Tip
Device: Thermage CPT
Treatment with Thermage pattern or framed tip
Experimental: Pattern Tip
Treatment with the Thermage CPT Pattern Tip
Device: Thermage CPT
Treatment with Thermage pattern or framed tip
Experimental: Pattern Tip Group 2
Treatment with the Thermage CPT Pattern tip
Device: Thermage CPT
Treatment with Thermage pattern or framed tip

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783496

Locations
United States, California
Solta Medical Aesthetic Center
Hayward, California, United States, 94545
Sponsors and Collaborators
Solta Medical
Investigators
Principal Investigator: Ronald Wheeland, MD
  More Information

No publications provided

Responsible Party: Solta Medical
ClinicalTrials.gov Identifier: NCT01783496     History of Changes
Other Study ID Numbers: 13-136-TM-T
Study First Received: January 31, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014