Skin Aging Clinical Trial
Official title:
Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity
Verified date | November 2014 |
Source | Valeant Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Solta Medical Aesthetic Center | Hayward | California |
Lead Sponsor | Collaborator |
---|---|
Solta Medical |
United States,
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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