Skin Aging
Conditions
Brief summary
The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
Interventions
DEVICEThermage CPT
Treatment with Thermage patterned, total, or framed tip
Sponsors
Valeant Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Laxity | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Skin Laxity (Subject Self-assessed) | 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. |
| Subject Satisfaction With Treatment Results | 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'). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Framed Tip Treatment with Thermage CPT Framed Tip | 10 |
| Pattern Tip Treatment with the Thermage CPT Pattern Tip | 10 |
| Pattern Tip Group 2 Treatment with the Thermage CPT Pattern tip | 10 |
| Total Tip Treatment with the Thermage CPT Total tip | 10 |
| Framed and Patterned Tip Split face treatment with the Thermage CPT Framed and Patterned tips | 5 |
| Total and Patterned Tip Split face treatment with the Thermage CPT Total and Patterned tips | 5 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Pattern Tip | Framed and Patterned Tip | Total and Patterned Tip | Total | Total Tip | Pattern Tip Group 2 | Framed Tip |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 8.1 | 51.0 years STANDARD_DEVIATION 9.3 | 53.2 years STANDARD_DEVIATION 8 | 51.6 years STANDARD_DEVIATION 7.6 | 52.2 years STANDARD_DEVIATION 7.5 | 49.1 years STANDARD_DEVIATION 7.9 | 53.6 years STANDARD_DEVIATION 6.7 |
| Mean Fasil Laxity Scale | 2.6 units on a scale STANDARD_DEVIATION 0.5 | 2.5 units on a scale STANDARD_DEVIATION 0.4 | 3.0 units on a scale STANDARD_DEVIATION 0.5 | 2.7 units on a scale STANDARD_DEVIATION 0.5 | 2.7 units on a scale STANDARD_DEVIATION 0.8 | 2.7 units on a scale STANDARD_DEVIATION 0.3 | 2.7 units on a scale STANDARD_DEVIATION 0.4 |
| Region of Enrollment United States | 10 participants | 5 participants | 5 participants | 50 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 2 Participants | 5 Participants | 42 Participants | 10 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 0 Participants | 8 Participants | 0 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 6 / 10 | 1 / 10 | 6 / 10 | 2 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 10 | 1 / 10 | 0 / 10 | 1 / 10 | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Framed Tip | Improvement in Laxity | 0.6 units on a scale | Standard Deviation 0.5 |
| Pattern Tip | Improvement in Laxity | 1.0 units on a scale | Standard Deviation 0.5 |
| Pattern Tip Group 2 | Improvement in Laxity | 0.9 units on a scale | Standard Deviation 0.5 |
| Total Tip | Improvement in Laxity | 1.3 units on a scale | Standard Deviation 0.8 |
| Framed and Patterned Tip | Improvement in Laxity | 0.9 units on a scale | Standard Deviation 0.3 |
| Total and Patterned Tip | Improvement in Laxity | 1.4 units on a scale | Standard Deviation 0.4 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Framed Tip | Improvement in Skin Laxity (Subject Self-assessed) | 0.9 units on a scale | Standard Deviation 0.9 |
| Pattern Tip | Improvement in Skin Laxity (Subject Self-assessed) | 1.4 units on a scale | Standard Deviation 0.9 |
| Pattern Tip Group 2 | Improvement in Skin Laxity (Subject Self-assessed) | 1.1 units on a scale | Standard Deviation 0.5 |
| Total Tip | Improvement in Skin Laxity (Subject Self-assessed) | 1.2 units on a scale | Standard Deviation 0.8 |
| Framed and Patterned Tip | Improvement in Skin Laxity (Subject Self-assessed) | 1.3 units on a scale | Standard Deviation 1.1 |
| Total and Patterned Tip | Improvement in Skin Laxity (Subject Self-assessed) | 2.4 units on a scale | Standard Deviation 1 |
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').
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Framed Tip | Subject Satisfaction With Treatment Results | 56 percentage of subjects satisfied |
| Pattern Tip | Subject Satisfaction With Treatment Results | 60 percentage of subjects satisfied |
| Pattern Tip Group 2 | Subject Satisfaction With Treatment Results | 80 percentage of subjects satisfied |
| Total Tip | Subject Satisfaction With Treatment Results | 38 percentage of subjects satisfied |
| Framed and Patterned Tip | Subject Satisfaction With Treatment Results | 60 percentage of subjects satisfied |
| Total and Patterned Tip | Subject Satisfaction With Treatment Results | 75 percentage of subjects satisfied |