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

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ClinicalTrials.gov Identifier: NCT03454672
Recruitment Status : Terminated (Delay in recruitment as per last protocol amendment due to Covid-19)
First Posted : March 6, 2018
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Novoxel Ltd.

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.

Condition or disease Intervention/treatment Phase
Wrinkle Device: Tixel Device: Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor shall be blinded to the type of intervention when assessing the outcome of the treatment.
Primary Purpose: Treatment
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
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : November 10, 2020
Actual Study Completion Date : November 10, 2020

Arm Intervention/treatment
Experimental: Tixel
Tixel Treatment.
Device: Tixel
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
Other Name: Fractional

Active Comparator: Laser
Laser Treatment.
Device: Laser
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
Other Name: Fractional




Primary Outcome Measures :
  1. Safety of investigational device assessed by incidence of device-related/non-related undesired effects [ Time Frame: 10 months ]
    Incidence of undesired effects will be measured by quantifying AEs, SAEs or undesired effects and will be assessed for severity, causal relation to investigational device and duration.

  2. Blinded Evaluation of Performance as measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) [ Time Frame: 10 months ]
    The FWCS shall be assessed and quantified by 3 blinded assessors at study visits 1-8. The FWCS is classified as I-III, where I indicated mild/fine wrinkles and III indicates moderate wrinkles.


Secondary Outcome Measures :
  1. Subject Experience as measured by subject's subjective satisfaction [ Time Frame: 10 months ]
    Subjective satisfaction is scored on a scale from 1-5, with 1 indicating poorly satisfied and 5 indicating very satisfied.

  2. Pain level as measured by the Visual Analog Scale (VAS) [ Time Frame: 4 months ]
    VAS is scored on a scale from 0-10, with 0 indicating no pain and 10 indicating worst pain. This will be assessed at each treatment period.

  3. Subjective Subject Downtime Assessment [ Time Frame: 4 months ]
    This assessment determines the amount of time required for the subject to return to normal, daily activities. This will be assessed at each treatment period.

  4. Subjective Subject Response Assessment [ Time Frame: 4 months ]
    This assessment determines the time for the treatment area to return to normal (void or redness, edema and scabs). This will be assessed at visits 2-6.

  5. End-User Experience [ Time Frame: For the duration of the study, approximately 1.5 years ]
    The end-user shall fill out a questionnaire to enable assessment of the experience in relation to operation and installation of the device. This will be scored on a scale from 1-5, with 1 indicating poorly satisfied/strongly disagree and 5 indicating very satisfied/strongly agree. This assessment will occur 3 times during the study - after the investigator performs 5 treatments with each device, after performing 20-30 treatments with each device, and again after completing all required treatments with both devices.

  6. Performance as measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) [ Time Frame: 10 months ]
    The FWCS shall be assessed and quantified by the handling physician at study visits 1-8. The FWCS is classified as I-III, where I indicated mild/fine wrinkles and III indicates moderate wrinkles.

  7. Performance as measured by Improvement Global Assessment [ Time Frame: 10 months ]
    Improvement Global Assessment is scored on a scale from 1-4, with 1 indicating a poor response and 4 indicating an excellent response. This will be assessed at study visits 2-8.

  8. Performance as measured by 5-point Wrinkle Assessment Scale (WAS) [ Time Frame: 10 months ]
    The 5-point WAS is scored on a scale from 0-4, with 0 indicating no visible wrinkles and 4 indicating very deep wrinkles. This will be assessed at study visits 1-8.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454672


Locations
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United States, New York
New York Laser & Skin Care
New York, New York, United States, 10028
Israel
Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center
Tel Aviv, Israel, 6937947
Sponsors and Collaborators
Novoxel Ltd.
Investigators
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Principal Investigator: Arielle NB Kauvar, M.D New York Laser & Skin Care Clinic
Study Director: Sharon Naim, B.Sc, Novoxel Ltd.
Principal Investigator: Rafi Carasso, M.D Hillel Yaffe Medical Center
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Responsible Party: Novoxel Ltd.
ClinicalTrials.gov Identifier: NCT03454672    
Other Study ID Numbers: CLN-0460
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Novoxel Ltd.:
periorbital
wrinkles
double-arm
Tixel
Laser
controlled
randomized
double
arm
fractional
resurfacing