Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
NCT ID: NCT01811017
Last Updated: 2014-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-06-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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755nm Alexandrite Laser
755nm Alexandrite Laser
755nm Alexandrite Laser
755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
755nm Alexandrite Laser
755nm Alexandrite Laser
Interventions
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755nm Alexandrite Laser
755nm Alexandrite Laser
Eligibility Criteria
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Inclusion Criteria
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
3. Is willing to consent to participate in the study.
4. Is willing to shield the tattoo completely from sun exposure
5. Signs informed consent form
6. 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
2. Subjects mentally ill or incompetent
3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations
4. Subjects who are prisoners
5. Subjects with recent sun exposure and suntan in the area to be treated
6. Allergic tattoos (hypersensitivity to tattoo ink)
7. History of vitiligo or keloidal scarring
8. Tattoos located on the neck or face including cosmetic tattoos
9. Subjects unwilling to tolerate partial removal of the tattoo in this study
10. Infection or skin disease in the area to be treated
11. Subjects who are immunosuppressed (e.g. HIV)
12. Subject is pregnant or nursing
13. Use of oral isotretinoin within past 12 months
14. History of squamous cell carcinoma or melanoma
15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
16. Has any other reason determined by the physician to be ineligible to participate in the study
18 Years
85 Years
ALL
No
Sponsors
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Cynosure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Krantz
Role: STUDY_DIRECTOR
Cynosure, Inc.
Locations
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Boston Va Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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CYN12-PICO_MGH_TB
Identifier Type: -
Identifier Source: org_study_id
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