Trial Outcomes & Findings for A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser (NCT NCT03454672)
NCT ID: NCT03454672
Last Updated: 2024-08-23
Results Overview
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
baseline, 42 Weeks
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
Tixel
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
Laser Treatment.
Laser: Laser treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Tixel
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
Laser Treatment.
Laser: Laser treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
painful
|
1
|
2
|
|
Overall Study
Non-compliance
|
2
|
4
|
|
Overall Study
personal reasons
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser
Baseline characteristics by cohort
| Measure |
Tixel
n=34 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=34 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
54.44 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
53.79 years
STANDARD_DEVIATION 7.29 • n=7 Participants
|
54.11 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 42 WeeksPopulation: The images have been presented to the blinded assessors in pairs, in which the treatment arm allocation was masked.
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
Outcome measures
| Measure |
Tixel
n=24 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=22 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
|
1.6 FWCS units on scale
Standard Deviation 0.6
|
1.7 FWCS units on scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42)Population: Each patient's subjective opinion regarding the overall satisfaction with treatment, was measured every visit. The measurement scale contained 5-points: from excellent (5-very satisfied) to poor (1-poor or not satisfied at all). The calculated total score of the 3 questions ("improvement", "treatment experience", "expectations") is presented. the minimum score can be - 3, and the maximum score can be - 15
Subjective satisfaction is scored on a scale from 1-5, from excellent (5-very satisfied) to poor (1-poor or not satisfied at all). compring results from baseline to 42 weeks. total minimum total score - 3, total maximum score - 15
Outcome measures
| Measure |
Tixel
n=25 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=22 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
total score Treatment 1
|
9.4 Total Calculated Score on a Scale
Standard Deviation 3.5
|
9.1 Total Calculated Score on a Scale
Standard Deviation 3.2
|
|
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
total score Treatment 4
|
11.4 Total Calculated Score on a Scale
Standard Deviation 2.9
|
10.1 Total Calculated Score on a Scale
Standard Deviation 3.1
|
|
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
total score Treatment 5
|
11.7 Total Calculated Score on a Scale
Standard Deviation 3.0
|
10.7 Total Calculated Score on a Scale
Standard Deviation 3.5
|
|
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
total score FU1 month
|
11.4 Total Calculated Score on a Scale
Standard Deviation 3.3
|
11.0 Total Calculated Score on a Scale
Standard Deviation 3.2
|
|
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
total score FU3 months
|
11.8 Total Calculated Score on a Scale
Standard Deviation 2.5
|
10.8 Total Calculated Score on a Scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: visit 1 - visit 5Population: Chi-square test was applied to show if the difference of distribution between treatment groups.
This assessment determines the number of days required for the subject to return to normal, daily activities. This will be assessed at each treatment visit : visit 1 - visit 5. The downtime assessment was evaluated after each Tixel treatment visit. The therapist asked the subject in the next visit regarding the 3 parameters that relate to the total downtime assessment. The parameters were: 1. Return to work (Days) 2. Return to social activities (Days) 3. Scabs (Days) The results for subjective Downtime assessments were grouped by two categories: * More than 2 days vs. less or equal to 2 days for Return to work, Return to social activities, Redness, Edema, and Scabs. * More than 4 hours vs. less or equal to 4 hours for sensation of heat.
Outcome measures
| Measure |
Tixel
n=24 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=22 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5- Edema- more than 2 days
|
9 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5- Scabs- more than 2 days
|
9 participants
|
1 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5- Sensation of heat- more than 4 hours
|
0 participants
|
1 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 1 -Return to work - more that 2 days
|
5 participants
|
4 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 1 - Return to social activities more than 2 days
|
7 participants
|
7 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 1- Redness- more than 2 days
|
14 participants
|
13 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 1- Edema- more than 2 days
|
12 participants
|
9 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Tretatment 1 - Scabs - More than 2 days
|
17 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 1- Sensation of heat- more than 4 hours
|
2 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2 -Return to work - more that 2 days
|
3 participants
|
4 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2 - Return to social activities more than 2 days
|
4 participants
|
5 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2- Redness- more than 2 days
|
12 participants
|
12 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2- Edema- more than 2 days
|
10 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2- Scabs- more than 2 days
|
16 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 2- Sensation of heat- more than 4 hours
|
0 participants
|
1 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3 -Return to work - more that 2 days
|
4 participants
|
5 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3 - Return to social activities more than 2 days
|
4 participants
|
5 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3- Redness- more than 2 days
|
8 participants
|
8 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3- Edema- more than 2 days
|
8 participants
|
8 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3- Scabs- more than 2 days
|
9 participants
|
3 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 3- Sensation of heat- more than 4 hours
|
1 participants
|
3 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4 -Return to work - more that 2 days
|
4 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4 - Return to social activities more than 2 days
|
4 participants
|
6 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4- Redness- more than 2 days
|
9 participants
|
10 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4- Edema- more than 2 days
|
9 participants
|
7 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4- Scabs- more than 2 days
|
10 participants
|
2 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 4- Sensation of heat- more than 4 hours
|
1 participants
|
2 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5 -Return to work - more that 2 days
|
4 participants
|
2 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5 - Return to social activities more than 2 days
|
6 participants
|
3 participants
|
|
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
Treatment 5- Redness- more than 2 days
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: treatment 1 - treatment 5Population: The pain level was evaluated immediately after each Tixel or ResurFX treatment visit using the VAS questionnaire on a 0 to 10 scale
Secondary Safety- VAS is scored on a scale from 0-10, with 0 indicating no pain and 10 indicating worst pain. This will be assessed at each treatment over 8 weeks to 16 weeks (Depending on number of Treatments given).
Outcome measures
| Measure |
Tixel
n=24 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=22 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
tretament 1
|
4.6 score on a scale
Standard Deviation 2.7
|
6.5 score on a scale
Standard Deviation 2.1
|
|
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
treatment 2
|
4.2 score on a scale
Standard Deviation 2.7
|
5.6 score on a scale
Standard Deviation 2.8
|
|
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
treatment 4
|
3.2 score on a scale
Standard Deviation 2.4
|
5.1 score on a scale
Standard Deviation 2.0
|
|
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
treatment 5
|
2.9 score on a scale
Standard Deviation 2.5
|
5.7 score on a scale
Standard Deviation 2.0
|
|
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
treatment 3
|
4.2 score on a scale
Standard Deviation 2.6
|
5.9 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: After performing 5 treatments with each device. After performing between 20 or 30 treatments with each device. After completing all the required treatments in the investigator's study site with both devices.Population: End of user experience total score
The scores were converted to the same scale (a minimal score of 10 and a maximal score of 100 ) for both treatments, where a score of 10 is considered the wors outcome, and a score of 100 is considered the better outcome. For ResurFX, the maximal score is 45 therefore, the transformed score= total score \*45 /100; for Tixel the maximal score is 50 therefore the transformed score =\*50/100.
Outcome measures
| Measure |
Tixel
n=24 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=22 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Number on End-User Experience Scale
After performing 5 treatments with each device. 100 excellent satisfaction.
|
82.2 score on a scale
Interval 10.0 to 100.0
|
62.0 score on a scale
Interval 10.0 to 100.0
|
|
Number on End-User Experience Scale
After performing between 20 or 30 treatments with each device. 100 excellent satisfaction.
|
86.7 score on a scale
Interval 10.0 to 100.0
|
80.0 score on a scale
Interval 10.0 to 100.0
|
|
Number on End-User Experience Scale
After completing all the required treatments in the investigator's study site with both devices.
|
93.3 score on a scale
Interval 10.0 to 100.0
|
93.0 score on a scale
Interval 10.0 to 100.0
|
SECONDARY outcome
Timeframe: baseline, 42 WeeksPopulation: Fitzpatrick Wrinkle Classification Score- Change
The FWCS shall be assessed and quantified by the handling physician at study visits 1-8. The FWCS is classified as I-III, where I indicated mild/fine wrinkles and III indicates moderate wrinkles. (baseline to 42 weeks)
Outcome measures
| Measure |
Tixel
n=31 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=30 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)
|
0.5 units on a scale
Standard Deviation 1.0
|
0.1 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: visit 2, 3, 4, follow up 1, 2, 3Population: global improvement assessment
Improvement Global Assessment is scored on a scale from 1-4, with 1 indicating a poor response and 4 indicating an excellent response. This will be assessed at study visits 2-8. (from week 4- week 42)
Outcome measures
| Measure |
Tixel
n=34 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=34 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
treatment 2
|
1.58 score on a scale
Standard Deviation 0.62
|
1.6 score on a scale
Standard Deviation 0.67
|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
treatment 3
|
1.86 score on a scale
Standard Deviation 0.79
|
2.00 score on a scale
Standard Deviation 0.83
|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
treatment 4
|
2.12 score on a scale
Standard Deviation 0.78
|
2.29 score on a scale
Standard Deviation 0.69
|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
follow up 1
|
1.89 score on a scale
Standard Deviation 0.64
|
2.23 score on a scale
Standard Deviation 0.87
|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
follow up 2
|
2.22 score on a scale
Standard Deviation 0.82
|
2.47 score on a scale
Standard Deviation 0.83
|
|
Mean Improvement Performance as Measured by Improvement Global Assessment
follow up 3
|
2.20 score on a scale
Standard Deviation 0.82
|
2.50 score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 42 WeeksPopulation: Skin assessments Changes from baseline
The 5-point WAS is scored on a scale from 0-4, with 0 indicating no visible wrinkles and 4 indicating very deep wrinkles. This will be assessed at study visits 1-8. (baseline to 42 weeks)
Outcome measures
| Measure |
Tixel
n=31 Participants
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=30 Participants
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)
|
0.3 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.4
|
Adverse Events
Tixel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Laser
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tixel
n=34 participants at risk
Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
Laser
n=34 participants at risk
Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
|
|---|---|---|
|
Eye disorders
Eye Dryness
|
2.9%
1/34 • Number of events 1 • 42 weeks
|
0.00%
0/34 • 42 weeks
|
|
Eye disorders
Red eye
|
2.9%
1/34 • Number of events 1 • 42 weeks
|
0.00%
0/34 • 42 weeks
|
|
Eye disorders
Watering eyes
|
2.9%
1/34 • Number of events 1 • 42 weeks
|
0.00%
0/34 • 42 weeks
|
|
Eye disorders
Uveitis
|
0.00%
0/34 • 42 weeks
|
2.9%
1/34 • Number of events 1 • 42 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER