Status:
WITHDRAWN
Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
Lead Sponsor:
Cynosure, Inc.
Conditions:
Tattoos
Eligibility:
All Genders
18-85 years
Phase:
NA
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.
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
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01811017
Start Date
June 1 2012
End Date
May 1 2013
Last Update
February 5 2014
Active Locations (1)
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1
Boston Va Medical Center
Boston, Massachusetts, United States, 02130