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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tattoos | Device: 755nm Alexandrite Laser | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
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Device: 755nm Alexandrite Laser
755nm Alexandrite Laser |
Experimental: Nanosecond 755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
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Device: 755nm Alexandrite Laser
755nm Alexandrite Laser |
- Photographic Evaluation of Tattoo Clearance [ Time Frame: up to 3 months post last treatment ]
- Subject biopsy sampling [ Time Frame: up to 3 months post last treatment ]Histological evaluation of tissue samples pre-treatment and post-treatment
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 3 months post last treatment ]

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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 |
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

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
United States, Massachusetts | |
Boston Va Medical Center | |
Boston, Massachusetts, United States, 02130 |
Study Director: | Patricia Krantz | Cynosure, Inc. |
Responsible Party: | Cynosure, Inc. |
ClinicalTrials.gov Identifier: | NCT01811017 History of Changes |
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 |