N/A
Completed N=50
Thermage CPT for Treatment of Facial and Neck Laxity
Source: ClinicalTrials.gov NCT01783496 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Nov 2014
Primary outcomePrimary: Improvement in Laxity — 0.6; 1.0; 0.9; 1.3 units on a scale
Summary
The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Laxity |
0.6; 1.0; 0.9; 1.3; 0.9; 1.4 | — |
| SECONDARY Improvement in Skin Laxity (Subject Self-assessed) |
0.9; 1.4; 1.1; 1.2; 1.3; 2.4 | — |
| SECONDARY Subject Satisfaction With Treatment Results |
56; 60; 80; 38; 60; 75 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01783496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.