Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles

NCT04639713 | Completed Results FDA Device

• 1 other identifier: CLN 0749
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Wrinkle; Periorbital; Tixel 2; Fractional; Resurfacing

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment

  Baseline and 3 months visits

• The Mean Score Evaluation of the Pain and Discomfort for Each Treatment

  Up to 6 months

• Satisfaction Questionnaire

  up to 6 months

Study Arms (1)

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

Device: Tixel 2

Interventions

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.

Tixel 2

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 35-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
• 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 and/or Israeli law, depending on each specific study site.
• Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator and clinically noticeable wrinkles in the treating area.
• Stable body weight during the study period.
• Skin Type I - V as per Fitzpatrick Skin Scale

You may not qualify if:

• 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:
• a cosmetic procedure to improve peri-orbital rhytides (i.e. 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 12 months, over the periorbital area including botulinum toxin injections, microdermabrasion or prescription level glycolic acid treatments.
• Injectable filler in cheeks (mid face) 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

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (3)

Physicians Laser and Dermatology Institute

Chicago, Illinois, 60611, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Rabin Medical Center, Ha'Sharon Campus

Petah Tikva, 49100, Israel

Location

Results Point of Contact

• Title: Ifat Klein
• Organization: Novoxel Ltd

ifat@novoxel.com

972-52-6009860

Study Officials

• Jerome M Garden, MD

  Physicians Laser and Dermatology Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded assessed of the improvement would be done between Last FU images and baseline, following randomization of the images.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 20, 2020
• Study Start: March 2, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)