Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings

NCT05182502 | Unknown FDA Device

• 1 other identifier: Tixel2021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.

Conditions

Wrinkle

Keywords

wrinkle; photo damage

Outcome Measures

Primary Outcomes (1)

• Blinded photo evaluation

  blinded observer rating of photos for photo damage using the Fitzpatrick Wrinkle Classification Scale: Class Description Score Description I Fine wrinkles 1-3 Mild: Fine texture changes with subtly accentuated skin lines. II Fine to moderate depth wrinkles, Moderate number of lines 4-6 Moderate: Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia III Fine to deep wrinkles, numerous lines, with or without redundant skin folds 7-9 Severe: Multipapular and confluent elastosis (thickened, yellow, and pallid) approaching or consistent with cutis rhomboidalis.

  3 months post-treatment

Study Arms (1)

Tixel treatment arm

EXPERIMENTAL

subjects will receive 3 monthly treatments with the Tixel device

Device: Tixel

Interventions

Tixel DEVICE

Subjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage

Tixel treatment arm

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 25-70 years old with clinically evident photodamage.
• 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 per the treating investigator and clinically noticeable wrinkles in the treating area.
• 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.
• Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
• Subjects who have had the following treatments:
• a cosmetic procedure to improve rhytides (i.e. Carbon Dioxide/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 3 months
• prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 3 months, including botulinum toxin injections or microdermabrasion.
• Injectable filler in cheeks (mid face) temples and in the upper face area to be treated within 3 months of investigation.
• Any subject who has 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, premalignant or malignant lesion 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 face):
• skin malignancy, or any diagnosis of suspected malignancy
• Collagen vascular or bleeding disorder
• Immunosuppression or autoimmune disease

Sponsors & Collaborators

• Eric Bernstein, MD: lead
• Novoxel Ltd.: collaborator

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Study Officials

• Eric F. Bernstein, MD

  Main Line Center for Laser Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Photos will be evaluated in randomized blinded pairs pre- and post-treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Treatment of subjects with a device for facial rejuvenation and blinded comparison of pre- and post-treatment photos.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 10, 2022
• Study Start: January 7, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)