Clinical Trial: A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal

Brief Summary: To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.

Detailed Summary: The purpose of this investigation is to evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser for benign pigmented lesion (BPL) removal. Currently, the enlightenTM laser offers two wavelengths: 532nm KTP and 1064nm Nd:YAG. The version of the laser under investigation allows the user to choose from a range of wavelengths.
Sponsor: Cutera Inc.

Current Primary Outcome: Degree of improvement in treated lesions by independent blinded reviewers [ Time Frame: 6 weeks post-final treatment ]

Assessed by independent blinded reviewers (Physician's Global Assessment).


Original Primary Outcome: Degree of improvement in treated lesions [ Time Frame: 12 weeks post-final treatment ]

Assessed by independent blinded reviewers (Physician's Global Assessment).


Current Secondary Outcome: Degree of improvement in treated lesions by the investigator [ Time Frame: 6 weeks post-final treatment ]

Assessed by the Investigator (Physician's Global Assessment).


Original Secondary Outcome: Degree of improvement in treated lesions [ Time Frame: 12 weeks post-final treatment ]

Assessed by the Investigator (Physician's Global Assessment).


Information By: Cutera Inc.

Dates:
Date Received: December 17, 2015
Date Started: September 2015
Date Completion:
Last Updated: August 19, 2016
Last Verified: January 2016