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Completed

NCT Number: NCT01783496

Thermage CPT 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.

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Key information

Conditions

Skin Aging

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solta Medical Aesthetic Center

Hayward, California, 94545, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermage CPT

Device

Treatment with Thermage patterned, total, or framed tip

Primary outcomes

  1. Improvement in Laxity

    Time frame: 6 months

    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.

Secondary outcomes

  1. Improvement in Skin Laxity (Subject Self-assessed)

    Time frame: 6 months

    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.

  2. Subject Satisfaction With Treatment Results

    Time frame: 6 months

    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').

Sponsors and collaborators

Lead sponsor

Valeant Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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