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OpenTrials
Completed

NCT Number: NCT02110095

Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos

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

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Picosure Laser System

Device

Picosure Laser System for the Treatment of Unwanted Tattoos

Primary outcomes

  1. Number of Patients With Tattoo Clearance

    Time frame: 2 months post last treatment

    Tattoo clearance will be measured using baseline and 2 month post treatment photos using a photographic scale. The scale ranges from 0 to 10, where 10 is 100% improvement from the baseline photo.

Secondary outcomes

  1. Physician Satisfaction Questionnaire

    Time frame: 2 months post last treatment

    This measures the physician satisfaction from 1 to 5, where 5 is the most satisfied.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2014
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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