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

NCT ID: NCT03454672

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2020-09-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tixel

Tixel Treatment.

Group Type: EXPERIMENTAL

Tixel

Intervention Type: DEVICE

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

Laser

Laser Treatment.

Group Type: ACTIVE_COMPARATOR

Laser

Intervention Type: DEVICE

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

Interventions

Tixel

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

Intervention Type: DEVICE

Laser

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

Intervention Type: DEVICE

Other Intervention Names

Fractional; Fractional

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novoxel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle NB Kauvar, M.D

Role: PRINCIPAL_INVESTIGATOR

New York Laser & Skin Care Clinic

Sharon Naim, B.Sc,

Role: STUDY_DIRECTOR

Novoxel Ltd.

Rafi Carasso, M.D

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

New York Laser & Skin Care

New York, New York, United States

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

Tel Aviv, , Israel

Countries

United States; Israel

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLN-0460

Identifier Type: -

Identifier Source: org_study_id