Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816, United States
Completed
NCT Number: NCT01842815
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
Completed
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Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 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.
Exclusion criteria
- 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.
Treatment and study plan
755 nm alexandrite laser
Device755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
Primary outcomes
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Tattoo Clearance
Time frame: Post Treatment 1 (6 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
-
Tattoo Clearance
Time frame: Post Treatment 2 (12 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
-
Tattoo Clearance
Time frame: Post Treatment 3 (18 Weeks Post Baseline)
Clearance will be measured using a clearance aesthetic improvement scale. This scale ranges from 0 to 10, where 0 is 0% tattoo cleared compared to the baseline tattoo, and 10 is 100% of tattoo cleared compared to the baseline tattoo.
Sponsors and collaborators
Lead sponsor
Cynosure, Inc.
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 30, 2013
- Registry last updated
- Jan 5, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.