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OpenTrials
Completed

NCT Number: NCT01754207

Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos

The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.

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Key information

Conditions

Tattoos

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.
  • Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
  • 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

  • Is hypersensitive to light exposure.
  • Has active localized or systemic infection.
  • Is taking medication(s) for which sunlight is a contraindication.
  • Has a history of squamous cell carcinoma or melanoma.
  • Has a history of keloid scarring.
  • Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
  • Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  • 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 allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
  • Has any other reason determined by the physician to be ineligible to participate in the study.

Treatment and study plan

755nm Alexandrite Laser

Device

755nm Alexandrite Laser

755nm Alexandrite Laser with CAP Array

Device

755nm Alexandrite Laser with CAP Array

Primary outcomes

  1. Tattoo Clearance Using Photographic Evaluation

    Time frame: up to 3 months post last treatment

    2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
Dec 16, 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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