Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos

Completed · Not applicable

Conditions studied: Unwanted Tattoos

In brief

The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.

Key facts

Study ID

NCT02110095

Run by

Cynosure, Inc.

People needed

15

Starts

2014-01-01

Expected to finish

2016-11-01

Last updated by the study team

2020-12-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a healthy male or female between 18 and 85 years old.
• Is willing to consent to participate in the study.
• Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
• The tattoo must include red pigment.

You may not qualify if…

• Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• Is hypersensitive to light exposure OR takes photo sensitized medication.
• Has active or localized systemic infections.
• Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
• Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
• Has used Accutane within 6 months prior to enrollment.
• Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• Has a history of keloids.
• Has evidence of compromised wound healing.
• Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
• Is allergic to topical lidocaine or topical steroids.

Where it is running

• Skin Care Physicians — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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