CompletedInterventionalNot ApplicableUpdated Oct 26, 2020
Evaluation of the 755nm Alexandrite for Unwanted Tattoos | NCT01842815 | Trialant
CompletedInterventionalNot ApplicableUpdated Jan 5, 2021
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
ClinicalTrials.gov ID
NCT01842815
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
20Actual
Last Update Posted
Jan 5, 2021Actual
Start Date
Mar 2013
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
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.
Unwanted, Non Cosmetic, Tattoos
755 nm alexandrite laser
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Primary Purpose
Treatment
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Laser & Skin Surgery Center of Northern California