Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Typical duration for not_applicable
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
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
December 16, 2020
CompletedDecember 16, 2020
November 1, 2020
2.1 years
December 18, 2012
October 28, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Tattoo Clearance Using Photographic Evaluation
2D photography comparing pre and post treatment photos, where the percentage of tattoo clearance between the photos was determined by the evaluator.
up to 3 months post last treatment
Study Arms (1)
755nm Alexandrite Laser
EXPERIMENTAL755nm Alexandrite Laser
Interventions
755nm Alexandrite Laser with CAP Array
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 to remove them.
- Is willing to consent to participate in the study.
- 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:
- Is hypersensitive to light exposure.
- Has active localized or systemic infection.
- Is taking medication(s) for which sunlight is a contraindication.
- Has a history of squamous cell carcinoma or melanoma.
- Has a history of keloid scarring.
- Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cynosure, Inc.lead
Study Sites (1)
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jamie Trimper
- Organization
- Cynosure
Study Officials
- STUDY DIRECTOR
Patricia Krantz
Cynosure, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 21, 2012
Study Start
December 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
December 16, 2020
Results First Posted
December 16, 2020
Record last verified: 2020-11