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
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.
Novoxel Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The subject is able to provide written 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:
Subjects who have had the following treatments:
Existing or history of the following (when discussing skin conditions, refers only to the periorbital sites):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tixel Treatment.
Device: Tixel
Laser Treatment.
Device: Laser
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
Also known as: Fractional
Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
Also known as: Fractional
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
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)
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
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
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.
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
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
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
| Milestone | Tixel | Laser |
|---|---|---|
| Started | 34 | 34 |
| Completed | 25 | 22 |
| Not completed | 9 | 12 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Painful | 1 | 2 |
| Withdrew: Non-compliance | 2 | 4 |
| Withdrew: Personal reasons | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
The FWCS shall be assessed and quantified by 3 blinded assessors comparing baseline visit to +42 weeks visit.
| FWCS units on scale | Tixel | Laser |
|---|---|---|
| Mean Change by Blinded Assessor Evaluation by Fitzpatrick Classification of Facial Wrinkling (FWCS) Scale | 1.6 ± 0.6 | 1.7 ± 0.8 |
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
| Total Calculated Score on a Scale | Tixel | Laser |
|---|---|---|
| total score Treatment 1 | 9.4 ± 3.5 | 9.1 ± 3.2 |
| total score Treatment 4 | 11.4 ± 2.9 | 10.1 ± 3.1 |
| total score Treatment 5 | 11.7 ± 3.0 | 10.7 ± 3.5 |
| total score FU1 month | 11.4 ± 3.3 | 11.0 ± 3.2 |
| total score FU3 months | 11.8 ± 2.5 | 10.8 ± 3.3 |
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.
| participants | Tixel | Laser |
|---|---|---|
| Treatment 1 -Return to work - more that 2 days | 5 | 4 |
| Treatment 1 - Return to social activities more than 2 days | 7 | 7 |
| Treatment 1- Redness- more than 2 days | 14 | 13 |
| Treatment 1- Edema- more than 2 days | 12 | 9 |
| Tretatment 1 - Scabs - More than 2 days | 17 | 6 |
| Treatment 1- Sensation of heat- more than 4 hours | 2 | 6 |
| Treatment 2 -Return to work - more that 2 days | 3 | 4 |
| Treatment 2 - Return to social activities more than 2 days | 4 | 5 |
| Treatment 2- Redness- more than 2 days | 12 | 12 |
| Treatment 2- Edema- more than 2 days | 10 | 6 |
| Treatment 2- Scabs- more than 2 days | 16 | 6 |
| Treatment 2- Sensation of heat- more than 4 hours | 0 | 1 |
| Treatment 3 -Return to work - more that 2 days | 4 | 5 |
| Treatment 3 - Return to social activities more than 2 days | 4 | 5 |
| Treatment 3- Redness- more than 2 days | 8 | 8 |
| Treatment 3- Edema- more than 2 days | 8 | 8 |
| Treatment 3- Scabs- more than 2 days | 9 | 3 |
| Treatment 3- Sensation of heat- more than 4 hours | 1 | 3 |
| Treatment 4 -Return to work - more that 2 days | 4 | 6 |
| Treatment 4 - Return to social activities more than 2 days | 4 | 6 |
| Treatment 4- Redness- more than 2 days | 9 | 10 |
| Treatment 4- Edema- more than 2 days | 9 | 7 |
| Treatment 4- Scabs- more than 2 days | 10 | 2 |
| Treatment 4- Sensation of heat- more than 4 hours | 1 | 2 |
| Treatment 5 -Return to work - more that 2 days | 4 | 2 |
| Treatment 5 - Return to social activities more than 2 days | 6 | 3 |
| Treatment 5- Redness- more than 2 days | 10 | 5 |
| Treatment 5- Edema- more than 2 days | 9 | 6 |
| Treatment 5- Scabs- more than 2 days | 9 | 1 |
| Treatment 5- Sensation of heat- more than 4 hours | 0 | 1 |
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).
| score on a scale | Tixel | Laser |
|---|---|---|
| tretament 1 | 4.6 ± 2.7 | 6.5 ± 2.1 |
| treatment 2 | 4.2 ± 2.7 | 5.6 ± 2.8 |
| treatment 3 | 4.2 ± 2.6 | 5.9 ± 2.6 |
| treatment 4 | 3.2 ± 2.4 | 5.1 ± 2.0 |
| treatment 5 | 2.9 ± 2.5 | 5.7 ± 2.0 |
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.
| score on a scale | Tixel | Laser |
|---|---|---|
| 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) |
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)
| units on a scale | Tixel | Laser |
|---|---|---|
| Mean Score Performance as Measured by the Fitzpatrick Classification of Facial Wrinkling (FWCS) | 0.5 ± 1.0 | 0.1 ± 0.9 |
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)
| score on a scale | Tixel | Laser |
|---|---|---|
| treatment 2 | 1.58 ± 0.62 | 1.6 ± 0.67 |
| treatment 3 | 1.86 ± 0.79 | 2.00 ± 0.83 |
| treatment 4 | 2.12 ± 0.78 | 2.29 ± 0.69 |
| follow up 1 | 1.89 ± 0.64 | 2.23 ± 0.87 |
| follow up 2 | 2.22 ± 0.82 | 2.47 ± 0.83 |
| follow up 3 | 2.20 ± 0.82 | 2.50 ± 1.01 |
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)
| score on a scale | Tixel | Laser |
|---|---|---|
| Mean Score of Performance as Measured by 5-point Wrinkle Assessment Scale (WAS) | 0.3 ± 0.6 | 0.2 ± 0.4 |
Collected over 42 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tixel | 0/34 (0%) | 0/34 (0%) | 3/34 (8.8%) |
| Laser | 0/34 (0%) | 0/34 (0%) | 1/34 (2.9%) |
| Event | Tixel | Laser |
|---|---|---|
| Eye DrynessEye disorders | 1/34 | 0/34 |
| Red eyeEye disorders | 1/34 | 0/34 |
| Watering eyesEye disorders | 1/34 | 0/34 |
| UveitisEye disorders | 0/34 | 1/34 |
68 subjects were enrolled. They were randomly split into two arms (34/arm) in each site and underwent periorbital fractional treatments.
| Age, Categorical(Participants) | Tixel | Laser | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 31 | 63 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | Tixel | Laser | Total |
|---|---|---|---|
| Mean | 54.44 ± 7.16 | 53.79 ± 7.29 | 54.11 ± 7.22 |
| Sex: Female, Male(Participants) | Tixel | Laser | Total |
|---|---|---|---|
| Female | 34 | 30 | 64 |
| Male | 0 | 4 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Tixel | Laser | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 32 | 30 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tixel | Laser | Total |
|---|---|---|---|
| United States | 17 | 17 | 34 |
| Israel | 17 | 17 | 34 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Novoxel Ltd.