UnknownNot Applicable

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.

United States20 participantsStarted 2021-08-20

Plain-language 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.

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female 35-75 years old diagnosed with clinically evident fine (mild) to moderate depth periorbital wrinkles.
. Willingness and ability to comply with all required study activities including returning for follow-up visits and protocol requirements.
. The subject is able to provide written informed consent and perform the study's activities according to HIPAA guidelines.
. Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.
. Stable body weight during the study period.
. Skin Type I - V as per Fitzpatrick Skin Scale

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Adverse Events report

Timeframe: Up to 12 months

Effectiveness using Fitzpatrick Wrinkle Classification Scale (FWCS)

Timeframe: Up to 12 months

Trial details

NCT IDNCT05282979

SponsorPhysicians Laser and Dermatology Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-20

Contact for this trial

Megan Calderon

3122800890 megan@pldilaser.com

View on ClinicalTrials.gov More Wrinkle trials