Trial Outcomes & Findings for Thermage CPT for Treatment of Facial and Neck Laxity (NCT NCT01783496)
NCT ID: NCT01783496
Last Updated: 2017-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2017-06-09
Participant Flow
Participant milestones
| Measure |
Framed Tip
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
|
Pattern Tip Group 2
Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
|
Total Tip
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
Split face treatment with the Thermage CPT Total and Patterned tips
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
5
|
5
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
8
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Framed Tip
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
|
Pattern Tip Group 2
Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
|
Total Tip
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
Split face treatment with the Thermage CPT Total and Patterned tips
|
|---|---|---|---|---|---|---|
|
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
Thermage CPT for Treatment of Facial and Neck Laxity
Baseline characteristics by cohort
| Measure |
Framed Tip
n=10 Participants
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
n=10 Participants
Treatment with the Thermage CPT Pattern Tip
|
Pattern Tip Group 2
n=10 Participants
Treatment with the Thermage CPT Pattern tip
|
Total Tip
n=10 Participants
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
n=5 Participants
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
n=5 Participants
Split face treatment with the Thermage CPT Total and Patterned tips
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
51.0 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
53.2 years
STANDARD_DEVIATION 8.0 • n=10 Participants
|
51.6 years
STANDARD_DEVIATION 7.6 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
5 participants
n=21 Participants
|
5 participants
n=10 Participants
|
50 participants
n=115 Participants
|
|
Mean Fasil Laxity Scale
|
2.7 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.8 • n=4 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.4 • n=21 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.5 • n=10 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.5 • n=115 Participants
|
PRIMARY outcome
Timeframe: 6 monthsImprovement 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.
Outcome measures
| Measure |
Framed Tip
n=9 Participants
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
n=10 Participants
Treatment with the Thermage CPT Pattern Tip
|
Pattern Tip Group 2
n=10 Participants
Treatment with the Thermage CPT Pattern tip
|
Total Tip
n=8 Participants
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
n=5 Participants
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
n=4 Participants
Split face treatment with the Thermage CPT Total and Patterned tips
|
|---|---|---|---|---|---|---|
|
Improvement in Laxity
|
0.6 units on a scale
Standard Deviation 0.5
|
1.0 units on a scale
Standard Deviation 0.5
|
0.9 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 0.8
|
0.9 units on a scale
Standard Deviation 0.3
|
1.4 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 6 monthsImprovement 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.
Outcome measures
| Measure |
Framed Tip
n=9 Participants
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
n=10 Participants
Treatment with the Thermage CPT Pattern Tip
|
Pattern Tip Group 2
n=10 Participants
Treatment with the Thermage CPT Pattern tip
|
Total Tip
n=8 Participants
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
n=5 Participants
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
n=4 Participants
Split face treatment with the Thermage CPT Total and Patterned tips
|
|---|---|---|---|---|---|---|
|
Improvement in Skin Laxity (Subject Self-assessed)
|
0.9 units on a scale
Standard Deviation 0.9
|
1.4 units on a scale
Standard Deviation 0.9
|
1.1 units on a scale
Standard Deviation 0.5
|
1.2 units on a scale
Standard Deviation 0.8
|
1.3 units on a scale
Standard Deviation 1.1
|
2.4 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 6 monthssubjects 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').
Outcome measures
| Measure |
Framed Tip
n=9 Participants
Treatment with Thermage CPT Framed Tip
|
Pattern Tip
n=10 Participants
Treatment with the Thermage CPT Pattern Tip
|
Pattern Tip Group 2
n=10 Participants
Treatment with the Thermage CPT Pattern tip
|
Total Tip
n=8 Participants
Treatment with the Thermage CPT Total tip
|
Framed and Patterned Tip
n=5 Participants
Split face treatment with the Thermage CPT Framed and Patterned tips
|
Total and Patterned Tip
n=4 Participants
Split face treatment with the Thermage CPT Total and Patterned tips
|
|---|---|---|---|---|---|---|
|
Subject Satisfaction With Treatment Results
|
56 percentage of subjects satisfied
|
60 percentage of subjects satisfied
|
80 percentage of subjects satisfied
|
38 percentage of subjects satisfied
|
60 percentage of subjects satisfied
|
75 percentage of subjects satisfied
|
Adverse Events
Framed Tip
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pattern Tip
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Pattern Tip Group 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Total Tip
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Framed and Patterned Tip
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total and Patterned Tip
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Framed Tip
n=10 participants at risk
Treatment with Thermage CPT Framed Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Pattern Tip
n=10 participants at risk
Treatment with the Thermage CPT Pattern Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Pattern Tip Group 2
n=10 participants at risk
Treatment with the Thermage CPT Pattern tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Total Tip
n=10 participants at risk
Treatment with the Thermage CPT Total tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Framed and Patterned Tip
n=5 participants at risk
Split face treatment with the Thermage CPT Framed and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Total and Patterned Tip
n=5 participants at risk
Split face treatment with the Thermage CPT Total and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Surgical and medical procedures
Exploratory Vaginal Surgery
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
Other adverse events
| Measure |
Framed Tip
n=10 participants at risk
Treatment with Thermage CPT Framed Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Pattern Tip
n=10 participants at risk
Treatment with the Thermage CPT Pattern Tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Pattern Tip Group 2
n=10 participants at risk
Treatment with the Thermage CPT Pattern tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Total Tip
n=10 participants at risk
Treatment with the Thermage CPT Total tip
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Framed and Patterned Tip
n=5 participants at risk
Split face treatment with the Thermage CPT Framed and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
Total and Patterned Tip
n=5 participants at risk
Split face treatment with the Thermage CPT Total and Patterned tips
Thermage CPT: Treatment with Thermage patterned, total, or framed tip
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Surface irregularity
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Intermittent itching
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Mild discomfort in treatment area
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Jawline sensitivity
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
10.0%
1/10 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Tooth infection
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Cellular atypia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Gout
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Bruise due to fall
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Erythema due to scratch
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Renal and urinary disorders
hydronephrosis
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Pancreatitis
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diverticulitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Surgical and medical procedures
Gum grafting
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Rash due to sunscreen
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Accidental injestion of marijuana
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergies
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Fatigue
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Surgical and medical procedures
Dental procedure
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Hangnail infection
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Sleep apnea
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Endocrine disorders
Hashimoto's disease
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
|
General disorders
Headache
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator shall notify Sponsor of the intent to publish or present independent Study Data, and agrees not to publish or publicly present and/or discuss such data, Investigator's current findings and/or the results of the Study independently without the express written consent of Sponsor, which consent may be withheld. Prior to submission for publication or presentation, all draft manuscripts must be submitted, reviewed and approved by Sponsor for confidential material.
- Publication restrictions are in place
Restriction type: OTHER