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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
Summary
This trial is testing the safety and effectiveness of the Tixel fractional system, a device that uses gentle heat to improve skin damaged by sunlight. The study involves people who want to reduce their photodamage and will receive multiple treatments over a period of time. The goal is to see if this low-energy heat treatment can safely make their skin look better. Treating facial and scalp actinic keratoses with the Tixel device was found to be effective and safe.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
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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
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