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

NCT03454672 | Terminated Results FDA Device

• 1 other identifier: CLN-0460
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Wrinkle

Keywords

periorbital; wrinkles; double-arm; Tixel; Laser; controlled; randomized; double; arm; fractional; resurfacing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score

  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

  visit 1 - visit 5

• Pain Level as Measured by the Visual Analog Scale (VAS) Scale

  treatment 1 - treatment 5

• Number on End-User Experience 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.

• Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)

  baseline, 42 Weeks

Study Arms (2)

Tixel

EXPERIMENTAL

Tixel Treatment.

Device: Tixel

Laser

ACTIVE COMPARATOR

Laser Treatment.

Device: Laser

Interventions

Tixel DEVICE

Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.

Also known as: Fractional

Tixel

Laser DEVICE

Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.

Also known as: Fractional

Laser

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

You may not qualify if:

• 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

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (2)

New York Laser & Skin Care

New York, New York, 10028, United States

Location

Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center

Tel Aviv, 6937947, Israel

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Ifat Klein
• Organization: Novoxel Ltd

ifat@novoxel.com

+972-52-6009860

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor shall be blinded to the type of intervention when assessing the outcome of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: March 6, 2018
• Study Start: March 12, 2018
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: August 23, 2024
• Results First Posted: June 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)