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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
No Placebo-Only Group

Summary

This trial involves using the Tixel device to treat people with wrinkles around their eyes. The device gently heats the skin to encourage it to repair itself, which helps to smooth out wrinkles. Participants will receive up to four treatments, with follow-ups in the months after the last treatment. Treating facial and scalp actinic keratoses with the Tixel device was found to be effective and safe.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5 spots leftby Nov 2025
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