Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFebruary 5, 2014
February 1, 2014
11 months
December 6, 2012
February 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Photographic Evaluation of Tattoo Clearance
up to 3 months post last treatment
Secondary Outcomes (1)
Subject biopsy sampling
up to 3 months post last treatment
Other Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
up to 3 months post last treatment
Study Arms (2)
755nm Alexandrite Laser
EXPERIMENTAL755nm Alexandrite Laser
Nanosecond 755nm Alexandrite Laser
EXPERIMENTALNanosecond 755nm Alexandrite Laser
Interventions
755nm Alexandrite Laser
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cynosure, Inc.lead
Study Sites (1)
Boston Va Medical Center
Boston, Massachusetts, 02130, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patricia Krantz
Cynosure, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2012
First Posted
March 14, 2013
Study Start
June 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
February 5, 2014
Record last verified: 2014-02