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WrinkleNCT03454672

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

A study testing Tixel and Laser in people with Wrinkle, run by Novoxel Ltd. at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Wrinkle
What is being tested?
Tixel and Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesin 2 countries
Study dates
12 Mar 2018to 4 Sep 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female 40-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
  • Willingness and ability to comply with all required study activities and protocol requirements.
  • 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.

Who cannot join

  • 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.
  • Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating.
  • Subjects with significant exposure to critical amounts of ultraviolet light (Sun tan).
  • Subjects who have had the following treatments:
  • 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
  • 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
Show all 29Show fewer
  • Injectable filler in area to be treated within 9 months of investigation.
  • permanent facial implant
  • Any subject who have visible scars that may affect evaluation of response and/or quality of photography.
  • 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.
  • Existing or history of the following (when discussing skin conditions, refers only to the periorbital sites):
  • skin malignancy, or any diagnosis of suspected malignancy
  • Collagen or vascular or bleeding disease
  • Immunosuppression or autoimmune disease
  • Erythema with or without blistering
  • History of post inflammatory hyperpigmentation.
  • 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.
  • Any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).
  • Any disease that inhibits pain sensation
  • History of keloid formation, or hypertrophic scarring
  • Conditions affecting healing rate (i.e. diabetes mellitus I or II, vascular condition, etc.)
  • neuromuscular disorders
  • 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)
  • Subjects who have used, systemic treatment which may induce dyspigmentation, such as amiodarone, clofazinmine, minocycline or chloroquine.
  • 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.
  • Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment.
  • Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  • Enrollment in any active study involving the use of investigational devices or drugs.
  • Any other cause per the principal investigator's discretion.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • New York Laser & Skin Care

    New York, New York, 10028

Other trials in United States

Israel1 site

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

    Tel Aviv, 6937947

Other trials in Israel

About this study

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

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
Being tested
Tixel, Laser
Keywords
periorbital, wrinkles, double-arm, Tixel, Laser, controlled, randomized, double, arm, fractional, resurfacing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TixelDevice

    Also called Fractional

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

  • LaserDevice

    Also called Fractional

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

Study groups in NCT03454672
Study groupRoleWhat they receive
TixelExperimentalTixel Treatment.
Receives: Device: Tixel
LaserActive comparatorLaser Treatment.
Receives: Device: Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale

    The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.

    Measured: baseline, 42 Weeks

Secondary outcomes (7)

  1. Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score

    Subjective satisfaction is scored on a scale from 1-5, from excellent (5-very satisfied) to poor (1-poor or not satisfied at all). compring results from baseline to 42 weeks.

    total minimum total score - 3, total maximum score - 15

    Measured: Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42)

  2. Number of Days Reported by Subject Using Subjective Subject Downtime Assessment

    This assessment determines the number of days required for the subject to return to normal, daily activities. This will be assessed at each treatment visit : visit 1 - visit 5.

    The downtime assessment was evaluated after each Tixel treatment visit. The therapist asked the subject in the next visit regarding the 3 parameters that relate to the total downtime assessment.

    The parameters were:

    1. Return to work (Days)
    2. Return to social activities (Days)
    3. Scabs (Days)

    The results for subjective Downtime assessments were grouped by two categories:

    • More than 2 days vs. less or equal to 2 days for Return to work, Return to social activities, Redness, Edema, and Scabs.
    • More than 4 hours vs. less or equal to 4 hours for sensation of heat.

    Measured: visit 1 - visit 5

  3. Pain Level as Measured by the Visual Analog Scale (VAS) Scale

    Secondary Safety- 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 over 8 weeks to 16 weeks (Depending on number of Treatments given).

    Measured: treatment 1 - treatment 5

  4. Number on End-User Experience Scale

    The scores were converted to the same scale (a minimal score of 10 and a maximal score of 100 ) for both treatments, where a score of 10 is considered the wors outcome, and a score of 100 is considered the better outcome. For ResurFX, the maximal score is 45 therefore, the transformed score= total score *45 /100; for Tixel the maximal score is 50 therefore the transformed score =*50/100.

    Measured: 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.

  5. Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)

    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. (baseline to 42 weeks)

    Measured: baseline, 42 Weeks

  6. Mean Improvement Performance as Measured by Improvement Global Assessment

    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. (from week 4- week 42)

    Measured: visit 2, 3, 4, follow up 1, 2, 3

  7. Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)

    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. (baseline to 42 weeks)

    Measured: 42 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2018
  2. Study start12 Mar 2018
  3. Primary completion4 Sep 2020
  4. Study completion4 Sep 2020

Why it stopped: Delay in recruitment as per last protocol amendment due to Covid-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03454672
Sponsor's protocol ID
CLN-0460
Status last verified
Aug 2024
First submitted
17 Feb 2018
Last updated
23 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tixel and Laser in people with Wrinkle, run by Novoxel Ltd. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale (time frame: baseline, 42 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03454672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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