Clinical Trial: A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal

Brief Summary: To evaluate the safety and efficacy of the Cutera excel HR dual wavelength 755nm Alexandrite and 1064nm Nd:YAG laser for hair removal.

Detailed Summary: This is a multi-center prospective, open-label, uncontrolled multi-center study of up to 50 male or female subjects, age 18 to 65 years, who desire laser hair removal. Subjects will receive 6 hair removal treatments, spaced 8 weeks apart, and will be followed at 12 weeks post-final treatment.
Sponsor: Cutera Inc.

Current Primary Outcome: Physician's Global Assessment [ Time Frame: 12 weeks ]

Percentage of hair reduction


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence and severity of adverse device effects [ Time Frame: 12 weeks ]

Assessment of ADEs immediately following each laser treatment and at the final follow-up visit


Original Secondary Outcome: Same as current

Information By: Cutera Inc.

Dates:
Date Received: August 27, 2015
Date Started: September 2015
Date Completion:
Last Updated: January 30, 2017
Last Verified: January 2017