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TerminatedNCT03454672Updated Aug 23, 2024Results posted

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

An interventional study of Tixel and Laser in Wrinkle, sponsored by Novoxel Ltd.. Terminated at 2 sites in 2 countries. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment

Why this study was terminated
Delay in recruitment as per last protocol amendment due to Covid-19
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wrinkle

Keywords

  • periorbital
  • wrinkles
  • double-arm
  • Tixel
  • Laser
  • controlled
  • randomized
  • double
  • arm
  • fractional
  • resurfacing
03

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Tixel

    Tixel Treatment.

    Device: Tixel

  • Active comparator
    Laser

    Laser Treatment.

    Device: Laser

Interventions

  • DeviceTixel

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

    Also known as: Fractional

  • DeviceLaser

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

    Also known as: Fractional

05

What researchers measure

Primary outcomes

  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.

    Time frame: baseline, 42 Weeks

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 42 Weeks

06

Results

Posted Jun 20, 2024

Participant flow

Participant flow — Overall Study
MilestoneTixelLaser
Started3434
Completed2522
Not completed912
Withdrew: Adverse event11
Withdrew: Lost to follow-up13
Withdrew: Painful12
Withdrew: Non-compliance24
Withdrew: Personal reasons32
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryMean 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.

Time frame:
baseline, 42 Weeks
Reported as:
Mean · FWCS units on scale
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale
FWCS units on scaleTixelLaser
Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale1.6 ± 0.61.7 ± 0.8
SecondaryMean 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

Time frame:
Treatment 1 (Baseline), Treatment 4 (Week 12), Treatment 5 (Week 16), Follow-up Visit 1 (Week 20), Follow-up Visit 3 (Week 42)
Reported as:
Mean · Total Calculated Score on a Scale
Mean Change of Subject Experience as Measured by Subject's Subjective Satisfaction Score
Total Calculated Score on a ScaleTixelLaser
total score Treatment 19.4 ± 3.59.1 ± 3.2
total score Treatment 411.4 ± 2.910.1 ± 3.1
total score Treatment 511.7 ± 3.010.7 ± 3.5
total score FU1 month11.4 ± 3.311.0 ± 3.2
total score FU3 months11.8 ± 2.510.8 ± 3.3
SecondaryNumber 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.

Time frame:
visit 1 - visit 5
Reported as:
Number · participants
Number of Days Reported by Subject Using Subjective Subject Downtime Assessment
participantsTixelLaser
Treatment 1 -Return to work - more that 2 days54
Treatment 1 - Return to social activities more than 2 days77
Treatment 1- Redness- more than 2 days1413
Treatment 1- Edema- more than 2 days129
Tretatment 1 - Scabs - More than 2 days176
Treatment 1- Sensation of heat- more than 4 hours26
Treatment 2 -Return to work - more that 2 days34
Treatment 2 - Return to social activities more than 2 days45
Treatment 2- Redness- more than 2 days1212
Treatment 2- Edema- more than 2 days106
Treatment 2- Scabs- more than 2 days166
Treatment 2- Sensation of heat- more than 4 hours01
Treatment 3 -Return to work - more that 2 days45
Treatment 3 - Return to social activities more than 2 days45
Treatment 3- Redness- more than 2 days88
Treatment 3- Edema- more than 2 days88
Treatment 3- Scabs- more than 2 days93
Treatment 3- Sensation of heat- more than 4 hours13
Treatment 4 -Return to work - more that 2 days46
Treatment 4 - Return to social activities more than 2 days46
Treatment 4- Redness- more than 2 days910
Treatment 4- Edema- more than 2 days97
Treatment 4- Scabs- more than 2 days102
Treatment 4- Sensation of heat- more than 4 hours12
Treatment 5 -Return to work - more that 2 days42
Treatment 5 - Return to social activities more than 2 days63
Treatment 5- Redness- more than 2 days105
Treatment 5- Edema- more than 2 days96
Treatment 5- Scabs- more than 2 days91
Treatment 5- Sensation of heat- more than 4 hours01
SecondaryPain 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).

Time frame:
treatment 1 - treatment 5
Reported as:
Mean · score on a scale
Pain Level as Measured by the Visual Analog Scale (VAS) Scale
score on a scaleTixelLaser
tretament 14.6 ± 2.76.5 ± 2.1
treatment 24.2 ± 2.75.6 ± 2.8
treatment 34.2 ± 2.65.9 ± 2.6
treatment 43.2 ± 2.45.1 ± 2.0
treatment 52.9 ± 2.55.7 ± 2.0
SecondaryNumber 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.

Time frame:
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.
Reported as:
Mean · score on a scale
Number on End-User Experience Scale
score on a scaleTixelLaser
After performing 5 treatments with each device. 100 excellent satisfaction.82.2 (10 to 100)62.0 (10 to 100)
After performing between 20 or 30 treatments with each device. 100 excellent satisfaction.86.7 (10 to 100)80.0 (10 to 100)
After completing all the required treatments in the investigator's study site with both devices.93.3 (10 to 100)93.0 (10 to 100)
SecondaryMean 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)

Time frame:
baseline, 42 Weeks
Reported as:
Mean · units on a scale
Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)
units on a scaleTixelLaser
Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS)0.5 ± 1.00.1 ± 0.9
SecondaryMean 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)

Time frame:
visit 2, 3, 4, follow up 1, 2, 3
Reported as:
Mean · score on a scale
Mean Improvement Performance as Measured by Improvement Global Assessment
score on a scaleTixelLaser
treatment 21.58 ± 0.621.6 ± 0.67
treatment 31.86 ± 0.792.00 ± 0.83
treatment 42.12 ± 0.782.29 ± 0.69
follow up 11.89 ± 0.642.23 ± 0.87
follow up 22.22 ± 0.822.47 ± 0.83
follow up 32.20 ± 0.822.50 ± 1.01
SecondaryMean 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)

Time frame:
42 Weeks
Reported as:
Mean · score on a scale
Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)
score on a scaleTixelLaser
Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS)0.3 ± 0.60.2 ± 0.4

Adverse events

Collected over 42 weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tixel0/34 (0%)0/34 (0%)3/34 (8.8%)
Laser0/34 (0%)0/34 (0%)1/34 (2.9%)
Most frequent other events
Most frequent other events
EventTixelLaser
Eye DrynessEye disorders1/340/34
Red eyeEye disorders1/340/34
Watering eyesEye disorders1/340/34
UveitisEye disorders0/341/34

Baseline characteristics

68 subjects were enrolled. They were randomly split into two arms (34/arm) in each site and underwent periorbital fractional treatments.

Age, Categorical
Age, Categorical(Participants)TixelLaserTotal
<=18 years000
Between 18 and 65 years323163
>=65 years235
Age, Continuous
Age, Continuous(years)TixelLaserTotal
Mean54.44 ± 7.1653.79 ± 7.2954.11 ± 7.22
Sex: Female, Male
Sex: Female, Male(Participants)TixelLaserTotal
Female343064
Male044
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TixelLaserTotal
Hispanic or Latino246
Not Hispanic or Latino323062
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)TixelLaserTotal
United States171734
Israel171734
07

Study locations

2 sites
  • New York Laser & Skin Care
    New York, New York 10028, United States
  • Dr. Artzi Skin Center Clinic - Linked to Hillel Yaffe Medical Center
    Tel Aviv, 6937947, Israel
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 24, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03454672
Lead sponsor
Novoxel Ltd.
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Mar 12, 2018
Primary completion
Sep 4, 2020
Completion
Sep 4, 2020
Results posted
Jun 20, 2024
Last update
Aug 23, 2024

Study contacts

Arielle NB Kauvar, M.D
principal investigator · New York Laser & Skin Care Clinic
Sharon Naim, B.Sc,
study director · Novoxel Ltd.
Rafi Carasso, M.D
principal investigator · Hillel Yaffe Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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