WrinkleNCT04639713
Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles
A study testing Tixel 2 in people with Wrinkle and Periorbital, run by Novoxel Ltd. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Periorbital, Tixel 2
- What is being tested?
- Tixel 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Mar 2021to 4 Apr 2022
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 35-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
- Willingness and ability to comply with all required study activities including returning for follow-up visits 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.
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator and clinically noticeable wrinkles in the treating area.
- Stable body weight during the study period.
- Skin Type I - V as per Fitzpatrick Skin Scale
Who cannot join
- Past treatment with Tixel device.
- 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.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- 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:
Show all 30Show fewer
- 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
- 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.
- Injectable filler in cheeks (mid face) temples and in the upper face area to be treated within 12 months of investigation.
- 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.
- 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, 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.
- 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 over the treated area (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; Subjects currently taking long-term oral steroid treatment.
- 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 major surgery or overnight hospitalization during the study that can affect the study schedule or treatment evaluation.
- 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
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Physicians Laser and Dermatology Institute
Chicago, Illinois, 60611
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles
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.
Read the 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:
- Baseline (1st tx)
- Phone-call visit (3 days after the first treatment)
- 4wk (2nd tx)
- 8wk (3rd tx)
- 12wk (4th tx)
- 4 weeks after the last treatment (1st FU)
- 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.
- Conditions
- Wrinkle, Periorbital, Tixel 2, Fractional, Resurfacing
- Being tested
- Tixel 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tixel 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Tixel 2 | Experimental | 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 Receives: Device: Tixel 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Safety Adverse Events
Evaluation of related adverse events up to the 3-month after a treatment visit.
Measured: 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.
Measured: baseline and at 3 months
Secondary outcomes (3)
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:
- expectational improvement; 2) very improved patient; 3) Improved patient; 4) Unaltered patient; 5) Worsened patient
Measured: 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.
Measured: 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".
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start2 Mar 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novoxel Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome M Garden, MD, Principal investigator, Physicians Laser and Dermatology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639713
- Sponsor's protocol ID
- CLN 0749
- Status last verified
- Feb 2024
- First submitted
- 19 Nov 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT04639713
- Acronym / sponsor ID
- CLN 0749
- Conditions
- Wrinkle, Periorbital, Tixel 2, Fractional, Resurfacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novoxel Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Baseline (1st tx)
- Phone-call visit (3 days after the first treatment)
- 4wk (2nd tx)
- 8wk (3rd tx)
- 12wk (4th tx)
- 4 weeks after the last treatment (1st FU)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo treatment with Tixel 2 Device - 4 treatments, 4 weeks apart and 2 Follow Up visits
| Arm | Type | Receives |
|---|---|---|
| Tixel 2 | Experimental | Device: Tixel 2Tixel 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 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 35-70 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkling
- Willingness and ability to comply with all required study activities including returning for follow-up visits 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.
- Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator and clinically noticeable wrinkles in the treating area.
- Stable body weight during the study period.
Key exclusion criteria (30 listed)
- Past treatment with Tixel device.
- 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.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tixel 2Thermo-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. | Device | Tixel 2 |
Primary outcome
Percentage of Participants With Safety Adverse Events
Time frame: 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
Time frame: 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.
3 secondary outcomes
The Mean Evaluation of Improvement Assessed by the Handling Physician by Using GAIS Scale - Global Aesthetic Improvement Scale Assessment
Time frame: Baseline and 3 months visits
The Mean Score Evaluation of the Pain and Discomfort for Each Treatment
Time frame: Up to 6 months
Satisfaction Questionnaire
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome M Garden, MD principal investigator
Physicians Laser and Dermatology Institute
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel 2 in people with Wrinkle and Periorbital, run by Novoxel Ltd. at 3 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 6 inclusion and 30 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: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 19 Mar 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?
Percentage of Participants With Safety Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.