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Completed

NCT Number: NCT02110121

Picosure Alexandrite Laser and Revlite Nd:Yag Laser for the Treatment of Unwanted Tattoos

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cynosure Inc.

Westford, Massachusetts, 01886, 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 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.

Exclusion criteria

  • 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

Treatment and study plan

Picosure Laser System

Device

Picosure Laser System for the Treatment of Unwanted Tattoos

Revlite Laser System

Device

Revlite Laser System for the Treatment of Unwanted Tattoos

Primary outcomes

  1. Tattoo Clearance

    Time frame: 2 months post each patient's last treatment, approximately 15 months

    Clearance will be measured using a blinded photograph evaluation scale. This ranges from 0 to 3, where a score of 0 is 0-25%, 1 is 25-50% clearance rating, 2 is 50-75%, and 3 is >75%. Photographs will be taken of the subjects at baseline and post treatment. The results will be compared to determine clearance.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2014
Registry last updated
Feb 9, 2021

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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