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A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
A Prospective, Multicenter, Single-Arm Clinical Study of 51 subjects who are seeking a procedure to reduce the appearance of the periorbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive 4 treatments with Tixel in a monthly interval. Follow-up will occur at 1 month and 3 months following the last treatment.
The clinic visits will be as follow:
Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tixel 2 | Experimental | Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tixel 2 | Device | Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Safety Adverse Events | Evaluation of related adverse events up to the 3-month after a treatment visit. | 6 months |
| The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better. | baseline and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment | Assessment of improvement using Global Aesthetic Improvement Scale Assessment at each visit compared to baseline by the handling physician. Rating: 1) expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient |
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Inclusion Criteria:
Exclusion Criteria:
Past treatment with Tixel device.
The subject may not undergo treatment by the Tixel 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.
Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
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 or other visible changes over the treated areas 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 over the treated area (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; Subjects currently taking long-term oral steroid treatment.
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 major surgery or overnight hospitalization during the study that can affect the study schedule or treatment evaluation.
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 |
|---|---|---|
| Jerome M Garden, MD | Physicians Laser and Dermatology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Laser and Dermatology Institute | Chicago | Illinois | 60611 | United States | ||
| Laser & Skin Surgery Center of New York |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tixel 2 | Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tixel 2 | Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. |
| 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 | Percentage of Participants With Safety Adverse Events | Evaluation of related adverse events up to the 3-month after a treatment visit. | Posted | Number | Percentage of Participants | 6 months |
|
6 months
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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 2 | Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits Tixel 2: Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Erythema |
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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 | Jan 4, 2021 | Aug 12, 2023 | Prot_SAP_000.pdf |
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All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits
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Blinded assessed of the improvement would be done between Last FU images and baseline, following randomization of the images.
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| Baseline and 3 months visits |
| The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-points scale. Each line will be awarded a score of 0 - 10 according to the level of pain when 0 is no pain and 10 is the maximum pain possible. | Up to 6 months |
| Satisfaction Questionnaire | Subject Experience (Satisfaction) questionnaire - Subjects assessed their satisfaction at the follow up visits. The following parameters were assessed: results of treatment, treatment experience and expectations (indicating whether the treatment has fulfilled the subject's expectations). For each parameter, the assessment was based on a 5-point scale: 1 = "Poor - Poor or not satisfied at all", 2 ="Fair - satisfied to some extent", 3 = "Moderately - Satisfied", 4 = "Good - Satisfied", 5 = "Excellent - Very Satisfied". | up to 6 months |
| New York |
| New York |
| 10016 |
| United States |
| Rabin Medical Center, Ha'Sharon Campus | Petah Tikva | 49100 | Israel |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
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| Primary | The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better. | subjects who received at least one tixel treatment | Posted | Mean | Standard Deviation | score on a scale | baseline and at 3 months |
|
|
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| Secondary | The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment | Assessment of improvement using Global Aesthetic Improvement Scale Assessment at each visit compared to baseline by the handling physician. Rating: 1) expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient | subjects who received Tixel treatments | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months visits |
|
|
|
| Secondary | The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-points scale. Each line will be awarded a score of 0 - 10 according to the level of pain when 0 is no pain and 10 is the maximum pain possible. | pain and discomfort following treatment, reported by the subjects who treated with tixel | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months |
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|
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| Secondary | Satisfaction Questionnaire | Subject Experience (Satisfaction) questionnaire - Subjects assessed their satisfaction at the follow up visits. The following parameters were assessed: results of treatment, treatment experience and expectations (indicating whether the treatment has fulfilled the subject's expectations). For each parameter, the assessment was based on a 5-point scale: 1 = "Poor - Poor or not satisfied at all", 2 ="Fair - satisfied to some extent", 3 = "Moderately - Satisfied", 4 = "Good - Satisfied", 5 = "Excellent - Very Satisfied". | subject who treated with tixel | Posted | Count of Participants | Participants | up to 6 months |
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| 0 |
| 51 |
| 0 |
| 51 |
| 2 |
| 51 |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Back pain |
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| Title | Measurements |
|---|---|
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| procedure-associated VAS - treatment 3 |
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| procedure-associated VAS - treatment 4 |
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