Picosure Alexandrite Laser and Revlite Nd:Yag 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 and Revlite Laser Systems for the treatment of unwanted tattoos.

Key facts

Study ID

NCT02110121

Run by

Cynosure, Inc.

People needed

63

Starts

2014-02-01

Expected to finish

2017-03-01

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 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.

You may not qualify if…

• The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• The subject is hypersensitive to light exposure OR takes photo sensitizing medication.
• The subject has active or localized systemic infections.
• The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
• The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• The subject 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.
• The subject has used Accutane within 6 months prior to enrollment.
• The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• The subject has a history of keloid scar formation.
• The subject has evidence of compromised wound healing.
• The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
• The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.14. The subject has red tattoo ink allergy

Where it is running

• Cynosure Inc. — Westford, Massachusetts, United States

Full record on ClinicalTrials.gov

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