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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01783496
Other study ID # 13-136-TM-T
Secondary ID
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


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
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