Split-tattoo Study Comparing the Safety and Efficacy of 670nm Picosecond Laser Versus 755 nm for Tattoo Removal
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02912507|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tattoo Removal||Device: Cutera enlighten laser Device: CynoSure PicoSure 755nm laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Split-tattoo Study Comparing the Safety and Efficacy of the 670nm Picosecond Laser Versus the 755 nm Picosecond Laser for Tattoo Removal|
|Actual Study Start Date :||September 9, 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Investigational Enlighten Device
Tattoo removal treatments with the investigational Cutera enlighten laser
Device: Cutera enlighten laser
high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal
Other Name: 670nm Picosecond Laser
Active Comparator: Cynosure PicoSure 755 nm laser
Tattoo removal treatments with the Cynosure PicoSure 755 nm laser
Device: CynoSure PicoSure 755nm laser
high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.
- Degree of tattoo clearing as assessed by the Investigator (Physician's Global Assessment of Improvement) [ Time Frame: 6 weeks post-final treatment ]Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician's Global Assessment of Improvement).
- Subject satisfaction using the Subject Satisfaction Assessment Scale [ Time Frame: 6 weeks post-final treatment ]Subject satisfaction levels at 6 weeks post-final treatment using the Subject Satisfaction Assessment Scale.
- Degree of tattoo clearing as assessed by Blinded Reviewer using the Global Assessment of Improvement Scale [ Time Frame: 6 weeks post-final treatment ]Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers using the Global Assessment of Improvement Scale
- Adverse Device Effects [ Time Frame: through study completion, an average of 1 year ]Number and severity of adverse device effects during the study period, displayed as frequency counts.
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): NCT02912507
|United States, Florida|
|Laser Skin Solutions Jacksonville|
|Jacksonville Beach, Florida, United States, 32250|
|Principal Investigator:||Jill Lezaic, DO||Laser Skin Solutions Jacksonville|