A Study of a Novel Multi-Wavelength Laser for Tattoo Removal
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|ClinicalTrials.gov Identifier: NCT02910505|
Recruitment Status : Unknown
Verified September 2016 by Cutera Inc..
Recruitment status was: Recruiting
First Posted : September 22, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tattoo Removal||Device: enLighten Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Treatment with investigational Cutera enlighten laser for tattoo removal
Device: enLighten Laser
Laser for tattoo removal
- Tattoo clearing as rated by Investigator [ 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).
- Tattoo clearing as rated by Subject [ Time Frame: 6 weeks post-final treatment ]Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the subject (Subject's Global Assessment of Improvement).
- Subject satisfaction Questionnaire [ Time Frame: 6 weeks post-final treatment ]Subject satisfaction levels at 6 weeks post-final treatment using Subject Satisfaction Assessment Scale.
- Tattoo clearing as rated by Blinded Evaluator [ Time Frame: 6 weeks post-final treatment ]Degree of tattoo clearing at 6 weeks post-final treatment as assessed by independent blinded reviewers (Global Assessment of Improvement).
- Adverse Device Effects [ Time Frame: through study completion, an average of 1 year ]Number and severity of adverse device effects during the study period
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): NCT02910505
|Contact: Emily Huemail@example.com|
|United States, Connecticut|
|Connecticut Skin Institute||Recruiting|
|Stamford, Connecticut, United States, 06905|
|Contact: John Liongson 203-428-4440 firstname.lastname@example.org|
|Principal Investigator:||Omar Ibrahimi, MD||Connecticut Skin Institute|