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Delay in recruitment as per last protocol amendment due to Covid-19
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tixel | Experimental | Tixel Treatment. |
|
| Laser | Active Comparator | Laser Treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tixel | Device | Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 42 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42) |
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Inclusion Criteria:
Male or female 40-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
Willingness and ability to comply with all required study activities and protocol requirements.
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.
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Exclusion Criteria:
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.
Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating.
Subjects with significant exposure to critical amounts of ultraviolet light (Sun tan).
Subjects who have had the following treatments:
Any subject who have visible scars that may affect evaluation of response and/or quality of photography.
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.
Existing or history of the following (when discussing skin conditions, refers only to the periorbital sites):
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)
Subjects who have used, systemic treatment which may induce dyspigmentation, such as amiodarone, clofazinmine, minocycline or chloroquine.
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.
Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Enrollment in any active study involving the use of investigational devices or drugs.
Any other cause per the principal investigator's discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Arielle NB Kauvar, M.D | New York Laser & Skin Care Clinic | Principal Investigator |
| Sharon Naim, B.Sc, | Novoxel Ltd. | Study Director |
| Rafi Carasso, M.D | Hillel Yaffe Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Laser & Skin Care | New York | New York | 10028 | United States | ||
| Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tixel | Tixel Treatment. Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
| FG001 | Laser | Laser Treatment. Laser: Laser treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
68 subjects were enrolled. They were randomly split into two arms (34/arm) in each site and underwent periorbital fractional treatments.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tixel | Tixel Treatment. Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
| BG001 | Laser | Laser Treatment. Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The images have been presented to the blinded assessors in pairs, in which the treatment arm allocation was masked. | Posted | Mean | Standard Deviation | FWCS units on scale | baseline, 42 Weeks |
|
42 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tixel | Tixel Treatment. Tixel: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Dryness | Eye disorders | MedDRA (10.0) | Systematic Assessment | Dry eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ifat Klein | Novoxel Ltd | +972-52-6009860 | ifat@novoxel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2019 | Jul 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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.
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The assessor shall be blinded to the type of intervention when assessing the outcome of the treatment.
| Laser | Device | 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 | 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:
The results for subjective Downtime assessments were grouped by two categories:
| visit 1 - visit 5 |
| 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). | treatment 1 - treatment 5 |
| 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. | 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. |
| 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) | baseline, 42 Weeks |
| 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) | visit 2, 3, 4, follow up 1, 2, 3 |
| 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) | 42 Weeks |
| Tel Aviv |
| 6937947 |
| Israel |
| painful |
|
| Non-compliance |
|
| personal reasons |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | Total Calculated Score on a Scale | Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42) |
|
|
|
| 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:
The results for subjective Downtime assessments were grouped by two categories:
| Chi-square test was applied to show if the difference of distribution between treatment groups. | Posted | Number | participants | visit 1 - visit 5 |
|
|
|
| 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). | The pain level was evaluated immediately after each Tixel or ResurFX treatment visit using the VAS questionnaire on a 0 to 10 scale | Posted | Mean | Standard Deviation | score on a scale | treatment 1 - treatment 5 |
|
|
|
| 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. | End of user experience total score | Posted | Mean | Full Range | score on a 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. |
|
|
|
| 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) | Fitzpatrick Wrinkle Classification Score- Change | Posted | Mean | Standard Deviation | units on a scale | baseline, 42 Weeks |
|
|
|
| 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) | global improvement assessment | Posted | Mean | Standard Deviation | score on a scale | visit 2, 3, 4, follow up 1, 2, 3 |
|
|
|
| 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) | Skin assessments Changes from baseline | Posted | Mean | Standard Deviation | score on a scale | 42 Weeks |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 3 |
| 34 |
| EG001 | Laser | Laser Treatment. Laser: Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response. | 0 | 34 | 0 | 34 | 1 | 34 |
| Red eye | Eye disorders | MedDRA (10.0) | Systematic Assessment | Ocular hyperemia |
|
| Watering eyes | Eye disorders | MedDRA (10.0) | Systematic Assessment | Lacrimation increased |
|
| Uveitis | Eye disorders | MedDRA (10.0) | Systematic Assessment | Uveitis |
|
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| total score Treatment 5 |
|
| total score FU1 month |
|
| total score FU3 months |
|
| Treatment 1- Redness- more than 2 days |
|
| Treatment 1- Edema- more than 2 days |
|
| Tretatment 1 - Scabs - More than 2 days |
|
| Treatment 1- Sensation of heat- more than 4 hours |
|
| Treatment 2 -Return to work - more that 2 days |
|
| Treatment 2 - Return to social activities more than 2 days |
|
| Treatment 2- Redness- more than 2 days |
|
| Treatment 2- Edema- more than 2 days |
|
| Treatment 2- Scabs- more than 2 days |
|
| Treatment 2- Sensation of heat- more than 4 hours |
|
| Treatment 3 -Return to work - more that 2 days |
|
| Treatment 3 - Return to social activities more than 2 days |
|
| Treatment 3- Redness- more than 2 days |
|
| Treatment 3- Edema- more than 2 days |
|
| Treatment 3- Scabs- more than 2 days |
|
| Treatment 3- Sensation of heat- more than 4 hours |
|
| Treatment 4 -Return to work - more that 2 days |
|
| Treatment 4 - Return to social activities more than 2 days |
|
| Treatment 4- Redness- more than 2 days |
|
| Treatment 4- Edema- more than 2 days |
|
| Treatment 4- Scabs- more than 2 days |
|
| Treatment 4- Sensation of heat- more than 4 hours |
|
| Treatment 5 -Return to work - more that 2 days |
|
| Treatment 5 - Return to social activities more than 2 days |
|
| Treatment 5- Redness- more than 2 days |
|
| Treatment 5- Edema- more than 2 days |
|
| Treatment 5- Scabs- more than 2 days |
|
| Treatment 5- Sensation of heat- more than 4 hours |
|
| treatment 3 |
|
| treatment 4 |
|
| treatment 5 |
|
| After completing all the required treatments in the investigator's study site with both devices. |
|
| treatment 3 |
|
|
| treatment 4 |
|
|
| follow up 1 |
|
|
| follow up 2 |
|
|
| follow up 3 |
|
|