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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

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