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

A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings

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

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Device: Tixel

Detailed Description

A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Ardmore, Pennsylvania, United States, 19003
      • Main Line Center for Laser Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female 25-70 years old with clinically evident photodamage.
2. Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements.
3. The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines.
4. Fitzpatrick wrinkle score of 3-7 in the per the treating investigator and clinically noticeable wrinkles in the treating area.
5. Skin Type I - V as per Fitzpatrick Skin Scale.

Exclusion Criteria:

1. Past treatment with Tixel device.
2. 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.
3. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
4. Female subjects who are pregnant or planning to become pregnant.
5. Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).

6. Subjects who have had the following treatments:

   1. a cosmetic procedure to improve rhytides (i.e. Carbon Dioxide/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 3 months
   2. prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 3 months, including botulinum toxin injections or microdermabrasion.
   3. Injectable filler in cheeks (mid face) temples and in the upper face area to be treated within 3 months of investigation.
7. 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.
8. 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.

9. Existing or history of the following (when discussing skin conditions, refers only to the face):

   1. skin malignancy, or any diagnosis of suspected malignancy
   2. Collagen vascular or bleeding disorder
   3. Immunosuppression or autoimmune disease
   4. Active acne vulgaris, herpes simplex virus 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.
   5. Any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).
   6. Any disease that inhibits pain sensation
   7. History of keloid formation, or hypertrophic scarring
   8. Conditions affecting healing rate (diabetes mellitus I or II)
   9. neuromuscular disorders
10. Subjects who have used, within 30 days, any medication 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)
11. Subjects who have used, systemic treatment which may induce dyspigmentation, such as amiodarone, clofazimine, or chloroquine.
12. Subjects currently taking or have taken an oral retinoid in the past six months; Subjects currently taking long-term oral corticosteroid treatment.
13. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment.
14. Subjects who anticipate the need for major surgery or overnight hospitalization during the study that can affect the study schedule or treatment evaluation.
15. Enrollment in any active study involving the use of investigational devices or drugs.
16. Any other cause per the principal investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tixel treatment arm; subjects will receive 3 monthly treatments with the Tixel device	Device: Tixel; Subjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eric Bernstein, MD
• Collaborators: Novoxel Ltd.
• Investigators: Principal Investigator: Eric F. Bernstein, MD, Main Line Center for Laser Surgery

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: wrinkle; photo damage
• Other Study ID Numbers: Tixel2021

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