A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Double Arm, Controlled Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles in Comparison With Fractional Laser

Conditions
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Wrinkle

Intervention / Treatment
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* Device: Tixel
* Device: Laser


Participation Criteria
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Eligibility Criteria
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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. ___________________________________________________________ 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: 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 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 Injectable filler in area to be treated within 9 months of investigation. permanent facial implant 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): skin malignancy, or any diagnosis of suspected malignancy Collagen or vascular or bleeding disease Immunosuppression or autoimmune disease Erythema with or without blistering History of post inflammatory hyperpigmentation. 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. Any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.). Any disease that inhibits pain sensation History of keloid formation, or hypertrophic scarring Conditions affecting healing rate (i.e. diabetes mellitus I or II, vascular condition, etc.) neuromuscular disorders 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel<br>Tixel Treatment. | Device: Tixel<br>* Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.<br>* Other names: Fractional;|
| Active Comparator: Laser<br>Laser Treatment. | Device: Laser<br>* Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.<br>* Other names: Fractional;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of investigational device assessed by incidence of device-related/non-related undesired effects | Incidence of undesired effects will be measured by quantifying AEs, SAEs or undesired effects and will be assessed for severity, causal relation to investigational device and duration. | 10 months | 
| Blinded Evaluation of Performance as measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) | The FWCS shall be assessed and quantified by 3 blinded assessors at study visits 1-8. The FWCS is classified as I-III, where I indicated mild/fine wrinkles and III indicates moderate wrinkles. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Experience as measured by subject's subjective satisfaction | Subjective satisfaction is scored on a scale from 1-5, with 1 indicating poorly satisfied and 5 indicating very satisfied. | 10 months | 
| Pain level as measured by the Visual Analog Scale (VAS) | 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 period. | 4 months | 
| Subjective Subject Downtime Assessment | This assessment determines the amount of time required for the subject to return to normal, daily activities. This will be assessed at each treatment period. | 4 months | 
| Subjective Subject Response Assessment | This assessment determines the time for the treatment area to return to normal (void or redness, edema and scabs). This will be assessed at visits 2-6. | 4 months | 
| End-User Experience | The end-user shall fill out a questionnaire to enable assessment of the experience in relation to operation and installation of the device. This will be scored on a scale from 1-5, with 1 indicating poorly satisfied/strongly disagree and 5 indicating very satisfied/strongly agree. This assessment will occur 3 times during the study - after the investigator performs 5 treatments with each device, after performing 20-30 treatments with each device, and again after completing all required treatments with both devices. | For the duration of the study, approximately 1.5 years | 
| 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. | 10 months | 
| 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. | 10 months | 
| 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. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periorbital, wrinkles, double-arm, Tixel, Laser, controlled, randomized, double, arm, fractional, resurfacing