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

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

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.

Study Overview

• Status: Terminated
• Conditions: Wrinkle
• Intervention / Treatment: Device: Tixel; Device: Laser

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 6937947
    • Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center
• United States
  • New York
    • New York, New York, United States, 10028
      • New York Laser & Skin Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)
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: Return to work (Days); Return to social activities (Days); 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.	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

Collaborators and Investigators

• Sponsor: Novoxel Ltd.
• Investigators: Principal Investigator: Arielle NB Kauvar, M.D, New York Laser & Skin Care Clinic; Study Director: Sharon Naim, B.Sc,, Novoxel Ltd.; Principal Investigator: Rafi Carasso, M.D, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: February 17, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: wrinkles; randomized; Laser; double; periorbital; fractional; controlled; double-arm; Tixel; arm; resurfacing
• Other Study ID Numbers: CLN-0460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No