WrinkleNCT05182502
Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
A study testing Tixel in people with Wrinkle, run by Eric Bernstein, MD at 1 site in United States.
Trial summary
To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Tixel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 25-70 years old with clinically evident photodamage.
- 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.
- Fitzpatrick wrinkle score of 3-7 in the per the treating investigator and clinically noticeable wrinkles in the treating area.
- 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.
- Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
- Subjects who have had the following treatments:
Show all 28Show fewer
- a cosmetic procedure to improve rhytides (i.e. Carbon Dioxide/Erbium/similar laser/fractional resurfacing, radiofrequency treatment) within 3 months
- prior facial treatments with laser, surgical, chemical or light-based facial treatments within the previous 3 months, including botulinum toxin injections or microdermabrasion.
- Injectable filler in cheeks (mid face) temples and in the upper face area to be treated within 3 months of investigation.
- Any subject who has 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, premalignant or malignant lesion 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 face):
- skin malignancy, or any diagnosis of suspected malignancy
- Collagen vascular or bleeding disorder
- Immunosuppression or autoimmune disease
- Active acne vulgaris, herpes simplex virus 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 (diabetes mellitus I or II)
- 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, clofazimine, or chloroquine.
- Subjects currently taking or have taken an oral retinoid in the past six months; Subjects currently taking long-term oral corticosteroid 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
1 site in 1 country.
United States1 site
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003
About this study
Official title: A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.
Read the detailed description
A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment
- Conditions
- Wrinkle
- Being tested
- Tixel
- Keywords
- wrinkle, photo damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TixelDevice
Subjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage
| Study group | Role | What they receive |
|---|---|---|
| Tixel treatment arm | Experimental | subjects will receive 3 monthly treatments with the Tixel device Receives: Device: Tixel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded photo evaluation
blinded observer rating of photos for photo damage using the Fitzpatrick Wrinkle Classification Scale: Class Description Score Description I Fine wrinkles 1-3 Mild: Fine texture changes with subtly accentuated skin lines.
II Fine to moderate depth wrinkles, Moderate number of lines 4-6 Moderate: Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia III Fine to deep wrinkles, numerous lines, with or without redundant skin folds 7-9 Severe: Multipapular and confluent elastosis (thickened, yellow, and pallid) approaching or consistent with cutis rhomboidalis.
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start7 Jan 2022
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment of subjects with a device for facial rejuvenation and blinded comparison of pre- and post-treatment photos.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Bernstein, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Novoxel Ltd.
- Responsible party
- Sponsor-investigator, Eric Bernstein, MD, Main Line Center for Laser Surgery
- Investigators
- Eric F. Bernstein, MD, Principal investigator, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182502
- Sponsor's protocol ID
- Tixel2021
- Status last verified
- Apr 2022
- First submitted
- 16 Dec 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings
- ClinicalTrials.gov ID
- NCT05182502
- Acronym / sponsor ID
- Tixel2021
- Conditions
- Wrinkle
- Keywords
- wrinkle, photo damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Eric Bernstein, MDUniversity, hospital or other
- Collaborators
- Novoxel Ltd.
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.
Detailed description
A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment of subjects with a device for facial rejuvenation and blinded comparison of pre- and post-treatment photos.
| Arm | Type | Receives |
|---|---|---|
| Tixel treatment arm | Experimental | Device: Tixelsubjects will receive 3 monthly treatments with the Tixel device |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 25-70 years old with clinically evident photodamage.
- 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.
- Fitzpatrick wrinkle score of 3-7 in the per the treating investigator and clinically noticeable wrinkles in the treating area.
- Skin Type I - V as per Fitzpatrick Skin Scale.
Key exclusion criteria (28 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.
- Subjects with significant exposure to critical amounts of ultraviolet light (Suntan).
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 |
|---|---|---|
| TixelSubjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage | Device | Tixel treatment arm |
Primary outcome
Blinded photo evaluation
Time frame: 3 months post-treatment
blinded observer rating of photos for photo damage using the Fitzpatrick Wrinkle Classification Scale: Class Description Score Description I Fine wrinkles 1-3 Mild: Fine texture changes with subtly accentuated skin lines. II Fine to moderate depth wrinkles, Moderate number of lines 4-6 Moderate: Distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia III Fine to deep wrinkles, numerous lines, with or without redundant skin folds 7-9 Severe: Multipapular and confluent elastosis (thickened, yellow, and pallid) approaching or consistent with cutis rhomboidalis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- 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.
Eric F. Bernstein, MD principal investigator
Main Line Center for Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel in people with Wrinkle, run by Eric Bernstein, MD at 1 site in United States.
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 5 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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?
Blinded photo evaluation (time frame: 3 months post-treatment). 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 6 Apr 2022.