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Fractional Skin Resurfacing Device
Tixel for Photodamage (Wrinkles)
N/A
Waitlist Available
Led By Eric F. Bernstein, MD
Research Sponsored by Eric Bernstein, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-treatment
Awards & highlights
Study Summary
This trial showed that the Tixel system is safe and effective for treating photodamage with low-energy settings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blinded photo evaluation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tixel treatment armExperimental Treatment1 Intervention
subjects will receive 3 monthly treatments with the Tixel device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tixel
2019
N/A
~60
Find a Location
Who is running the clinical trial?
Eric Bernstein, MDLead Sponsor
Novoxel Ltd.Industry Sponsor
8 Previous Clinical Trials
333 Total Patients Enrolled
2 Trials studying Wrinkles
119 Patients Enrolled for Wrinkles
Eric F. Bernstein, MDPrincipal InvestigatorMain Line Center for Laser Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have noticeable wrinkles in the area being treated and a wrinkle score of 3-7 according to the doctor.You are between 25 and 70 years old and have visible skin damage caused by sun exposure.Your skin type is within the range of Type I to V according to the Fitzpatrick Skin Scale.You have had filler injections in your cheeks, temples, or upper face area within the past 3 months.You have had or currently have a type of cancer that affects the skin, especially on your face.You have a condition that affects your connective tissues or causes problems with bleeding.You have a weakened immune system or a condition where your immune system attacks healthy cells in your body.You are between 25 and 70 years old and have visible signs of sun damage on your skin.The principal investigator can decide to exclude participants for any other reason they see fit.You have certain skin conditions that can cause blisters, hives, or make existing skin conditions worse.You have a condition that prevents you from feeling pain.You have a history of forming large scars or raised scars after injuries or surgeries.You have diabetes, which can affect how quickly your body heals.You have a condition that affects your muscles or nerves.You have used certain medications or treatments on your skin within the past 30 days that can make your skin sensitive or change its characteristics.You have noticeable wrinkles in the area being treated, as determined by the doctor.Your skin type is determined using the Fitzpatrick Skin Scale, which ranges from Type I to Type V.You have previously received treatment with the Tixel device.You have spent a lot of time in the sun and have gotten a significant tan.You have taken medications like amiodarone, clofazimine, or chloroquine that can cause changes in skin color.You are currently using or have used a medication called an oral retinoid in the past six months.
Research Study Groups:
This trial has the following groups:- Group 1: Tixel treatment arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Wrinkles Patient Testimony for trial: Trial Name: NCT05182502 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants under the age of 45 eligible for enrollment in this medical experiment?
"According to the requirements for enrolment, this study can only accept participants aged 25 and above up to a maximum age of 70."
Answered by AI
Are enrollment opportunities still available for this research initiative?
"Contrary to the information on clinicaltrials.gov, this trial is not currently enrolling patients. Initially posted on January 7th 2022, and updated April 4th 2022, it is temporarily inactive. However, there are 20 other trials actively recruiting at present."
Answered by AI
Might I be eligible to participate in this research trial?
"This trial seeks 25 adults, aged between 25 and 70 years old, with visible wrinkles in the target area. To be considered for enrollment, applicants must meet several criteria: Fitzpatrick Skin Type I - V; commitment to follow all study protocols including returning for follow-up visits; male or female gender of the required age range; and a Fitzpatrick wrinkle score of 3-7 as judged by the treating investigator."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New Jersey
South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Main Line Center for Laser Surgery
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I will do anything to get rid of wrinkles.
PatientReceived 1 prior treatment
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