Clinical trial NCT03454672: A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser
Official title: A Prospective, Randomized, Double Arm, Controlled Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles in Comparison With Fractional Laser
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrinkle
Keywords: periorbital
wrinkles
double-arm
Tixel
Laser
controlled
randomized
double
arm
fractional
resurfacing
Lead sponsor: Novoxel Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

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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.

Primary outcomes:
measure: Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
timeFrame: baseline, 42 Weeks
Secondary outcomes:
measure: Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
timeFrame: Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42)
measure: Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
timeFrame: visit 1 - visit 5
measure: Pain Level as Measured by the Visual Analog Scale (VAS) Scale
timeFrame: treatment 1 - treatment 5
measure: Number on End-User Experience Scale
timeFrame: 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.
measure: Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)
timeFrame: baseline, 42 Weeks
measure: Mean Improvement Performance as Measured by Improvement Global Assessment
timeFrame: visit 2, 3, 4, follow up 1, 2, 3
measure: Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)
timeFrame: 42 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Laser & Skin Care
state: New York
city: Tel Aviv
country: Israel
facility: Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center
Study officials:
affiliation: New York Laser & Skin Care Clinic
name: Arielle NB Kauvar, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Novoxel Ltd.
name: Sharon Naim, B.Sc,
role: STUDY_DIRECTOR
affiliation: Hillel Yaffe Medical Center
name: Rafi Carasso, M.D
role: PRINCIPAL_INVESTIGATOR
References: