Status:
COMPLETED
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
Lead Sponsor:
Cynosure, Inc.
Conditions:
Unwanted, Non Cosmetic, Tattoos
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01842815
Start Date
March 1 2013
End Date
December 1 2015
Last Update
January 5 2021
Active Locations (1)
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1
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816