Wrinkle
Conditions
Keywords
periorbital, wrinkles, double-arm, Tixel, Laser, controlled, randomized, double, arm, fractional, resurfacing
Brief summary
This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying thermal (heat) energy to the skin. The study shall compare the safety and the effectiveness of the Tixel with the safety and the effectiveness of a laser device which is currently cleared for marketing in the US.
Interventions
DEVICETixel
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
DEVICELaser
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
Sponsors
Novoxel Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor shall be blinded to the type of intervention when assessing the outcome of the treatment.
Intervention model description
The subjects will be randomly allocated to two equally sized groups, one shall be treated by the Tixel, and the other shall be treated by the laser comparator.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 40-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling 2. Willingness and ability to comply with all required study activities and protocol requirements. 3. The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines and/or Israeli law, depending on each specific study site. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Exclusion criteria
1. The subject may not undergo treatment by the Tixel or comparator device according to the device's contra-indications for use, as defined in the User Manual and in the Instructions for Use and by any other labeling of the device. 2. Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating. 3. Subjects with significant exposure to critical amounts of ultraviolet light (Sun tan). 4. Subjects who have had the following treatments: 1. a prior cosmetic procedure to improve facial rhytides (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 12 months 2. prior facial treatments with laser, surgical, chemical or light based facial treatments within the previous 6 months, such as for botulinum toxin injections, retinoid, microdermabrasion or prescription level glycolic acid treatments 3. Injectable filler in area to be treated within 9 months of investigation. 4. permanent facial implant 5. Any subject who have visible scars that may affect evaluation of response and/or quality of photography. 6. Subjects with any type of active cut, wound, inflammation, lesion (benign, premalignant or malignant) or active bacterial, viral, fungal, or herpetic infection on the skin on the designated treatment sites or in close proximity to it. 7. Existing or history of the following (when discussing skin conditions, refers only to the periorbital sites): 1. skin malignancy, or any diagnosis of suspected malignancy 2. Collagen or vascular or bleeding disease 3. Immunosuppression or autoimmune disease 4. Erythema with or without blistering 5. History of post inflammatory hyperpigmentation. 6. Active Acne Vulgaris, Herpes Simplex Virus (HSV-1), or any existing skin condition/disease that in the investigator's opinion would interfere with the evaluation of the safety of the study treatment. 7. Any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.). 8. Any disease that inhibits pain sensation 9. History of keloid formation, or hypertrophic scarring 10. Conditions affecting healing rate (i.e. diabetes mellitus I or II, vascular condition, etc.) 11. neuromuscular disorders 8. Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics (i.e. topically applied Retinoids, Hydroquinone, Chemical peel of any strength: glycolic acid, lactic acid, salicylic acid) 9. Subjects who have used, systemic treatment which may induce dyspigmentation, such as amiodarone, clofazinmine, minocycline or chloroquine. 10. Subjects currently taking or have taken an oral retinoid in the past six months (risk of scarring with therapy); Subjects currently taking long-term oral steroid treatment (causing fragility of the skin, risk of hematoma and bullae formation); Subjects taking Isotretinoin (Accutane or Roaccutan) within past 12 months. 11. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment. 12. Subjects who anticipate the need for surgery or overnight hospitalization during the study. 13. Enrollment in any active study involving the use of investigational devices or drugs. 14. Any other cause per the principal investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale | baseline, 42 Weeks | The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | visit 1 - visit 5 | 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. |
| Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 1 - treatment 5 | 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). |
| Number on End-User Experience Scale | 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. | 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. |
| Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42) | 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 |
| Mean Improvement Performance as Measured by Improvement Global Assessment | visit 2, 3, 4, follow up 1, 2, 3 | 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) |
| Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS) | 42 Weeks | 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) |
| Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) | baseline, 42 Weeks | 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) |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tixel Tixel Treatment.
Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. | 34 |
| Laser Laser Treatment.
Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Non-compliance | 2 | 4 |
| Overall Study | painful | 1 | 2 |
| Overall Study | personal reasons | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tixel | Laser | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 31 Participants | 63 Participants |
| Age, Continuous | 54.44 years STANDARD_DEVIATION 7.16 | 53.79 years STANDARD_DEVIATION 7.29 | 54.11 years STANDARD_DEVIATION 7.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Israel | 17 participants | 17 participants | 34 participants |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 34 Participants | 30 Participants | 64 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 3 / 34 | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
Time frame: baseline, 42 Weeks
Population: The images have been presented to the blinded assessors in pairs, in which the treatment arm allocation was masked.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tixel | Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale | 1.6 FWCS units on scale | Standard Deviation 0.6 |
| Laser | Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale | 1.7 FWCS units on scale | Standard Deviation 0.8 |
Secondary
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel | 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 |
| Tixel | 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 |
| Tixel | 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 |
| Tixel | 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 |
| Tixel | 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 |
| Laser | Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | total score FU3 months | 10.8 Total Calculated Score on a Scale | Standard Deviation 3.3 |
| Laser | Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | total score Treatment 1 | 9.1 Total Calculated Score on a Scale | Standard Deviation 3.2 |
| Laser | Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | total score Treatment 4 | 10.1 Total Calculated Score on a Scale | Standard Deviation 3.1 |
| Laser | Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | total score Treatment 5 | 10.7 Total Calculated Score on a Scale | Standard Deviation 3.5 |
| Laser | Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score | total score FU1 month | 11.0 Total Calculated Score on a Scale | Standard Deviation 3.2 |
Secondary
Mean Improvement Performance as Measured by Improvement Global 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)
Time frame: visit 2, 3, 4, follow up 1, 2, 3
Population: global improvement assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 3 | 1.86 score on a scale | Standard Deviation 0.79 |
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 1 | 1.89 score on a scale | Standard Deviation 0.64 |
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 2 | 1.58 score on a scale | Standard Deviation 0.62 |
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 2 | 2.22 score on a scale | Standard Deviation 0.82 |
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 3 | 2.20 score on a scale | Standard Deviation 0.82 |
| Tixel | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 4 | 2.12 score on a scale | Standard Deviation 0.78 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 3 | 2.50 score on a scale | Standard Deviation 1.01 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 2 | 1.6 score on a scale | Standard Deviation 0.67 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 3 | 2.00 score on a scale | Standard Deviation 0.83 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | treatment 4 | 2.29 score on a scale | Standard Deviation 0.69 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 1 | 2.23 score on a scale | Standard Deviation 0.87 |
| Laser | Mean Improvement Performance as Measured by Improvement Global Assessment | follow up 2 | 2.47 score on a scale | Standard Deviation 0.83 |
Secondary
Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)
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)
Time frame: 42 Weeks
Population: Skin assessments Changes from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tixel | Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS) | 0.3 score on a scale | Standard Deviation 0.6 |
| Laser | Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS) | 0.2 score on a scale | Standard Deviation 0.4 |
Secondary
Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)
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)
Time frame: baseline, 42 Weeks
Population: Fitzpatrick Wrinkle Classification Score- Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tixel | Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) | 0.5 units on a scale | Standard Deviation 1 |
| Laser | Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) | 0.1 units on a scale | Standard Deviation 0.9 |
Secondary
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
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.
Time frame: visit 1 - visit 5
Population: Chi-square test was applied to show if the difference of distribution between treatment groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Redness- more than 2 days | 14 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Redness- more than 2 days | 10 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Edema- more than 2 days | 12 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4 - Return to social activities more than 2 days | 4 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Tretatment 1 - Scabs - More than 2 days | 17 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Edema- more than 2 days | 9 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Sensation of heat- more than 4 hours | 2 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Sensation of heat- more than 4 hours | 1 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2 -Return to work - more that 2 days | 3 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Scabs- more than 2 days | 9 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2 - Return to social activities more than 2 days | 4 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Edema- more than 2 days | 9 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Redness- more than 2 days | 12 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Sensation of heat- more than 4 hours | 0 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Edema- more than 2 days | 10 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5 -Return to work - more that 2 days | 4 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Scabs- more than 2 days | 16 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Sensation of heat- more than 4 hours | 1 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Sensation of heat- more than 4 hours | 0 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Redness- more than 2 days | 9 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3 -Return to work - more that 2 days | 4 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1 -Return to work - more that 2 days | 5 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3 - Return to social activities more than 2 days | 4 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5 - Return to social activities more than 2 days | 6 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Redness- more than 2 days | 8 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1 - Return to social activities more than 2 days | 7 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Edema- more than 2 days | 8 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Scabs- more than 2 days | 10 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Scabs- more than 2 days | 9 participants |
| Tixel | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4 -Return to work - more that 2 days | 4 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Scabs- more than 2 days | 3 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4 -Return to work - more that 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4 - Return to social activities more than 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Redness- more than 2 days | 10 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Edema- more than 2 days | 7 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Scabs- more than 2 days | 2 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 4- Sensation of heat- more than 4 hours | 2 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5 -Return to work - more that 2 days | 2 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5 - Return to social activities more than 2 days | 3 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Redness- more than 2 days | 5 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Edema- more than 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Scabs- more than 2 days | 1 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 5- Sensation of heat- more than 4 hours | 1 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Sensation of heat- more than 4 hours | 3 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1 -Return to work - more that 2 days | 4 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1 - Return to social activities more than 2 days | 7 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Redness- more than 2 days | 13 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Edema- more than 2 days | 9 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Tretatment 1 - Scabs - More than 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 1- Sensation of heat- more than 4 hours | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2 -Return to work - more that 2 days | 4 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2 - Return to social activities more than 2 days | 5 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Redness- more than 2 days | 12 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Edema- more than 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Scabs- more than 2 days | 6 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 2- Sensation of heat- more than 4 hours | 1 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3 -Return to work - more that 2 days | 5 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3 - Return to social activities more than 2 days | 5 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Redness- more than 2 days | 8 participants |
| Laser | Number of Days Reported by Subject Using Subjective Subject Downtime Assessment | Treatment 3- Edema- more than 2 days | 8 participants |
Secondary
Number on End-User Experience Scale
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tixel | Number on End-User Experience Scale | After performing 5 treatments with each device. 100 excellent satisfaction. | 82.2 score on a scale |
| Tixel | 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 |
| Tixel | 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 |
| Laser | Number on End-User Experience Scale | After performing 5 treatments with each device. 100 excellent satisfaction. | 62.0 score on a scale |
| Laser | Number on End-User Experience Scale | After performing between 20 or 30 treatments with each device. 100 excellent satisfaction. | 80.0 score on a scale |
| Laser | Number on End-User Experience Scale | After completing all the required treatments in the investigator's study site with both devices. | 93.0 score on a scale |
Secondary
Pain Level as Measured by the Visual Analog Scale (VAS) 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).
Time frame: treatment 1 - treatment 5
Population: The pain level was evaluated immediately after each Tixel or ResurFX treatment visit using the VAS questionnaire on a 0 to 10 scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 2 | 4.2 score on a scale | Standard Deviation 2.7 |
| Tixel | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 4 | 3.2 score on a scale | Standard Deviation 2.4 |
| Tixel | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 3 | 4.2 score on a scale | Standard Deviation 2.6 |
| Tixel | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 5 | 2.9 score on a scale | Standard Deviation 2.5 |
| Tixel | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | tretament 1 | 4.6 score on a scale | Standard Deviation 2.7 |
| Laser | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 5 | 5.7 score on a scale | Standard Deviation 2 |
| Laser | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | tretament 1 | 6.5 score on a scale | Standard Deviation 2.1 |
| Laser | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 2 | 5.6 score on a scale | Standard Deviation 2.8 |
| Laser | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 3 | 5.9 score on a scale | Standard Deviation 2.6 |
| Laser | Pain Level as Measured by the Visual Analog Scale (VAS) Scale | treatment 4 | 5.1 score on a scale | Standard Deviation 2 |