An interventional study of Tixel 2 in Wrinkle, Periorbital and Tixel 2, sponsored by Novoxel Ltd.. Completed at 3 sites in 2 countries. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment
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.
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:
Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.
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.
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 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
Device: 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.
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
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
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
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
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
| Milestone | Tixel 2 |
|---|---|
| Started | 51 |
| Completed | 48 |
| Not completed | 3 |
| Withdrew: Protocol noncompliance | 2 |
| Withdrew: Withdrawal by subject | 1 |
Evaluation of related adverse events up to the 3-month after a treatment visit.
| Percentage of Participants | Tixel 2 |
|---|---|
| Percentage of Participants With Safety Adverse Events | 3.92 |
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.
| score on a scale | Tixel 2 |
|---|---|
| Assessed by evaluator #1 | 2.00 ± 0.83 |
| Assessed by evaluator #2 | 2.17 ± 0.71 |
| Assessed by evaluator #3 | 1.19 ± 0.55 |
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
| score on a scale | Tixel 2 |
|---|---|
| GAIS at visit 5 - 1 month FU | 3.54 ± 0.68 |
| GAIS at visit 6 - 3 months FU | 3.52 ± 0.58 |
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.
| score on a scale | Tixel 2 |
|---|---|
| procedure-associated VAS - treatment 1 | 2.98 ± 1.52 |
| procedure-associated VAS - treatment 2 | 2.94 ± 1.14 |
| procedure-associated VAS - treatment 3 | 2.82 ± 1.22 |
| procedure-associated VAS - treatment 4 | 2.81 ± 1.2 |
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".
| Participants | Tixel 2 |
|---|---|
| 'Very satisfied' with the results of the treatment | 23 |
| 'Very satisfied' with the treatment experience | 33 |
| 'Very satisfied' with regard to their expectations from treatment | 21 |
Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tixel 2 | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) |
| Event | Tixel 2 |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 1/51 |
| Back PainMusculoskeletal and connective tissue disorders | 1/51 |
| Age, Categorical(Participants) | Tixel 2 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 8 |
| Age, Continuous(years) | Tixel 2 |
|---|---|
| Mean | 56.8 ± 7.42 |
| Sex: Female, Male(Participants) | Tixel 2 |
|---|---|
| Female | 45 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Tixel 2 |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Tixel 2 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 49 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Tixel 2 |
|---|---|
| United States | 15 |
| Israel | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Novoxel Ltd.