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Procedure

Tixel 2 for Wrinkles

N/A
Waitlist Available
Led By Jerome Garden, M.D.
Research Sponsored by Physicians Laser and Dermatology Institute
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 up to 12 months
Awards & highlights

Study Summary

A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)
Safety Adverse Events report
Secondary outcome measures
Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)- Unblinded
Effectiveness using GAIS-Global Aesthetic Improvement Scale Assessment-Unblinded
Pain
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tixel 2Experimental Treatment1 Intervention
Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tixel 2
2021
N/A
~60

Find a Location

Who is running the clinical trial?

Physicians Laser and Dermatology InstituteLead Sponsor
Jerome Garden, M.D.Principal InvestigatorPhysician Laser & Dermatology Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
Indiana
How old are they?
18 - 65
What site did they apply to?
Physicians Laser & Dermatology Institute, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.
2021. "A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282979.
~5 spots leftby Apr 2025
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