CompletedInterventionalNot ApplicableUpdated Oct 4, 2023
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite | NCT01811017 | Trialant
WithdrawnInterventionalNot ApplicableUpdated Feb 5, 2014
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
ClinicalTrials.gov ID
NCT01811017
Lead Sponsor
Cynosure, Inc.INDUSTRY
Overall Status
Withdrawn
Study Type
Interventional
Phase
Not Applicable
Enrollment
0Actual
Last Update Posted
Feb 5, 2014Estimated
Start Date
Jun 2012
Primary Completion Date
May 2013Actual
Completion Date
May 2013Actual
Brief Summary
Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.
Tattoos
755nm 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
Is willing to consent to participate in the study.
Is willing to shield the tattoo completely from sun exposure
Signs informed consent form
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:
Subjects who are unwilling to consent to tattoos
Subjects mentally ill or incompetent
Subjects is unwilling to have photographs taken and used in publications or scientific presentations
Subjects who are prisoners
Subjects with recent sun exposure and suntan in the area to be treated
Allergic tattoos (hypersensitivity to tattoo ink)
History of vitiligo or keloidal scarring
Tattoos located on the neck or face including cosmetic tattoos
Subjects unwilling to tolerate partial removal of the tattoo in this study
Infection or skin disease in the area to be treated
Subjects who are immunosuppressed (e.g. HIV)
Subject is pregnant or nursing
Use of oral isotretinoin within past 12 months
History of squamous cell carcinoma or melanoma
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