A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.

Study Overview
=================
Brief Summary
-----------------
A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.

Detailed Description
-----------------
A Prospective, Single center, Single-Arm Clinical Study of 13-20 participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Each study participate will receive up to 4 treatments with Tixel in monthly interval. Follow-up will occur at 1 month and 3 months following the last visit. The clinic visits will be as follow: Base line (1st tx) Phone-call visit (3 days after the first treatment) 4 week (2nd tx) 8 week (3rd tx) 12 week (4th tx) 4 weeks after the last treatment (1st Follow-up) 12 weeks after the last treatment (2nd follow-up = 3 months follow-up, primary endpoint and the study completion visit) Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.

Official Title
-----------------
A Prospective, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles

Conditions
-----------------
Wrinkle

Intervention / Treatment
-----------------
* Device: Tixel 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 35-75 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkles. Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements. The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines. Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator. Stable body weight during the study period. Skin Type I - V as per Fitzpatrick Skin Scale 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 (Suntan). Subjects who have had the following treatments: a cosmetic procedure to improve periorbital rhytides within 6 months. Injectable filler in temples and in the upper face area to be treated within 12 months of investigation. 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): skin malignancy, or any diagnosis of suspected malignancy Collagen or vascular or bleeding disease Immunosuppression or autoimmune disease History of persistent beyond 2 years post inflammatory hyperpigmentation. Active Acne Vulgaris, 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 and evaluation. Any skin condition 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. 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 over the periorbital area 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 within 12 months, such as amiodarone, clofazinmine, minocycline or chloroquine. Subjects currently taking or have taken an oral retinoid in the past 6 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 which would impact the periorbital response. Any other cause per the principal investigator's discretion.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participates will undergo treatment with the Tixel 2 Device up to 4 treatments, 4 weeks apart and 2 Follow Up Visits
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel 2<br>Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits. | Device: Tixel 2<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Adverse Events report | Evaluation of related adverse events up to the 3-month after last treatment visit | Up to 12 months | 
| Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS) | 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. 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded | Assessment of improvement using Fitzpatrick Wrinkle Classification Scale (FWCS) at each visit compared to baseline by the handling physician. 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. | Up to 12 months | 
| Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded | Assessment of improvement using Global Aesthetic Improvement Scale Assessment at 1 month and 3 month follow up compared to baseline by the handling physician. Rating: 1) Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4)Unaltered patient; 5) Worsened patient | Up to 12 months | 
| Evaluation of the pain and discomfort | 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-point 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 maximum pain possible. | Up to 12 months | 
| Subject Subjective Downtime Assessment | Evaluation of the period of time following the procedure during which the subject felt unable/unwilling to go out in public. | Up to 12 months | 
| Patients' Reported Outcomes | Subject Satisfaction Questionnaire and GAIS- Global Aesthetic Improvement Scale Assessment. Rating: 1) Exceptional improvement patient; 2) Very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periorbital