Fractional, Periorbital, Resurfacing, Tixel 2, Wrinkle
Conditions
Brief summary
A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.
Detailed description
A Prospective, Multicenter, Single-Arm Clinical Study of 51 subjects who are seeking a procedure to reduce the appearance of the periorbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive 4 treatments with Tixel in a monthly interval. Follow-up will occur at 1 month and 3 months following the last treatment. The clinic visits will be as follow: 1. Baseline (1st tx) 2. Phone-call visit (3 days after the first treatment) 3. 4wk (2nd tx) 4. 8wk (3rd tx) 5. 12wk (4th tx) 6. 4 weeks after the last treatment (1st FU) 7. 12 weeks after the last treatment (2nd FU= 3 months FU, primary endpoint and study completion visit) Primary Efficacy Endpoint is the comparison of the proportion of subjects with a ≥ 1-score improvement on the FWCS at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
Interventions
DEVICETixel 2
Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.
Sponsors
Novoxel Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded assessed of the improvement would be done between Last FU images and baseline, following randomization of the images.
Intervention model description
All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 35-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling 2. Willingness and ability to comply with all required study activities including returning for follow-up visits 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. 4. Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator and clinically noticeable wrinkles in the treating area. 5. Stable body weight during the study period. 6. Skin Type I - V as per Fitzpatrick Skin Scale
Exclusion criteria
1. Past treatment with Tixel device. 2. The subject may not undergo treatment by the Tixel 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. 3. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability. 4. Female subjects who are pregnant, or planning to become pregnant, or have given birth less than 3 months ago or are lactating. 5. Subjects with significant exposure to critical amounts of ultraviolet light (Sun-tan). 6. Subjects who have had the following treatments: 1. a cosmetic procedure to improve peri-orbital rhytides (i.e. 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 12 months, over the periorbital area including botulinum toxin injections, microdermabrasion or prescription level glycolic acid treatments. 3. Injectable filler in cheeks (mid face) temples and in the upper face area to be treated within 12 months of investigation. 7. Any subject who have visible scars or other visible changes over the treated areas that may affect evaluation of response and/or quality of photography. 8. 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. 9. 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, 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 and evaluation. 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 10. Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics over the treated area (i.e. topically applied Retinoids, Hydroquinone, Chemical peel of any strength: glycolic acid, lactic acid, salicylic acid) 11. Subjects who have used, systemic treatment which may induce dyspigmentation, such as amiodarone, clofazinmine, minocycline or chloroquine. 12. Subjects currently taking or have taken an oral retinoid in the past six months; Subjects currently taking long-term oral steroid treatment. 13. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study treatment. 14. Subjects who anticipate the need for major surgery or overnight hospitalization during the study that can affect the study schedule or treatment evaluation. 15. Enrollment in any active study involving the use of investigational devices or drugs. 16. Any other cause per the principal investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Safety Adverse Events | 6 months | Evaluation of related adverse events up to the 3-month after a treatment visit. |
| The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | baseline and at 3 months | Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment | Baseline and 3 months visits | Assessment of improvement using Global Aesthetic Improvement Scale Assessment at each visit compared to baseline by the handling physician. Rating: 1\) expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient |
| The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | Up to 6 months | Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-points scale. Each line will be awarded a score of 0 - 10 according to the level of pain when 0 is no pain and 10 is the maximum pain possible. |
| Satisfaction Questionnaire | up to 6 months | Subject Experience (Satisfaction) questionnaire - Subjects assessed their satisfaction at the follow up visits. The following parameters were assessed: results of treatment, treatment experience and expectations (indicating whether the treatment has fulfilled the subject's expectations). For each parameter, the assessment was based on a 5-point scale: 1 = Poor - Poor or not satisfied at all, 2 =Fair - satisfied to some extent, 3 = Moderately - Satisfied, 4 = Good - Satisfied, 5 = Excellent - Very Satisfied. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tixel 2 Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject would be questioned about pain level, subjective dountime assessment and subjective response assessment. Images would be taken at baseline and in Follow-Up visits
Tixel 2: Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Noncompliance | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tixel 2 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 56.8 years STANDARD_DEVIATION 7.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment Israel | 36 participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 2 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Percentage of Participants With Safety Adverse Events
Evaluation of related adverse events up to the 3-month after a treatment visit.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tixel 2 | Percentage of Participants With Safety Adverse Events | 3.92 Percentage of Participants |
Primary
The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation
Comparison of the proportion of subjects with a ≥ 1-score improvement on the Fitzpatrick Wrinkle Classification Scale (FWCS) at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. The FWCS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower score is considered better.
Time frame: baseline and at 3 months
Population: subjects who received at least one tixel treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel 2 | The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | Assessed by evaluator #1 | 2.00 score on a scale | Standard Deviation 0.83 |
| Tixel 2 | The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | Assessed by evaluator #2 | 2.17 score on a scale | Standard Deviation 0.71 |
| Tixel 2 | The Mean Improvement and Treatment Effectiveness by Blinded Assessors Using Using the Fitzpatrick Wrinkle Classification Scale (FWCS) Evaluation | Assessed by evaluator #3 | 1.19 score on a scale | Standard Deviation 0.55 |
Secondary
Satisfaction Questionnaire
Subject Experience (Satisfaction) questionnaire - Subjects assessed their satisfaction at the follow up visits. The following parameters were assessed: results of treatment, treatment experience and expectations (indicating whether the treatment has fulfilled the subject's expectations). For each parameter, the assessment was based on a 5-point scale: 1 = Poor - Poor or not satisfied at all, 2 =Fair - satisfied to some extent, 3 = Moderately - Satisfied, 4 = Good - Satisfied, 5 = Excellent - Very Satisfied.
Time frame: up to 6 months
Population: subject who treated with tixel
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tixel 2 | Satisfaction Questionnaire | 'Very satisfied' with the results of the treatment | 23 Participants |
| Tixel 2 | Satisfaction Questionnaire | 'Very satisfied' with the treatment experience | 33 Participants |
| Tixel 2 | Satisfaction Questionnaire | 'Very satisfied' with regard to their expectations from treatment | 21 Participants |
Secondary
The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment
Assessment of improvement using Global Aesthetic Improvement Scale Assessment at each visit compared to baseline by the handling physician. Rating: 1\) expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient
Time frame: Baseline and 3 months visits
Population: subjects who received Tixel treatments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel 2 | The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment | GAIS at visit 5 - 1 month FU | 3.54 score on a scale | Standard Deviation 0.68 |
| Tixel 2 | The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment | GAIS at visit 6 - 3 months FU | 3.52 score on a scale | Standard Deviation 0.58 |
Secondary
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment
Evaluation of the pain and discomfort of the treatment as reported by the subject on a visual analog scale (VAS). Scoring will consist of making a mark on a 10-points scale. Each line will be awarded a score of 0 - 10 according to the level of pain when 0 is no pain and 10 is the maximum pain possible.
Time frame: Up to 6 months
Population: pain and discomfort following treatment, reported by the subjects who treated with tixel
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tixel 2 | The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | procedure-associated VAS - treatment 1 | 2.98 score on a scale | Standard Deviation 1.52 |
| Tixel 2 | The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | procedure-associated VAS - treatment 2 | 2.94 score on a scale | Standard Deviation 1.14 |
| Tixel 2 | The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | procedure-associated VAS - treatment 3 | 2.82 score on a scale | Standard Deviation 1.22 |
| Tixel 2 | The Mean Score Evaluation of the Pain and Discomfort for Each Treatment | procedure-associated VAS - treatment 4 | 2.81 score on a scale | Standard Deviation 1.2 |