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Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite

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ClinicalTrials.gov Identifier: NCT01811017
Recruitment Status : Withdrawn
First Posted : March 14, 2013
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tattoos Device: 755nm Alexandrite Laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
 Device: 755nm Alexandrite Laser
755nm Alexandrite Laser
Experimental: Nanosecond 755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
 Device: 755nm Alexandrite Laser
755nm Alexandrite Laser


Outcome Measures
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Primary Outcome Measures :
  1. Photographic Evaluation of Tattoo Clearance [ Time Frame: up to 3 months post last treatment ]

Secondary Outcome Measures :
  1. Subject biopsy sampling [ Time Frame: up to 3 months post last treatment ]
    Histological evaluation of tissue samples pre-treatment and post-treatment


Other Outcome Measures:
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 3 months post last treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is a healthy male or female between 18 and 85 years old?
  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:

  1. Subjects who are unwilling to consent to tattoos
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811017


Locations
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United States, Massachusetts
Boston Va Medical Center
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Cynosure, Inc.
Investigators
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Study Director: Patricia Krantz Cynosure, Inc.
More Information
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Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01811017    
Other Study ID Numbers: CYN12-PICO_MGH_TB
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014