F1 Diode LaserTM thirty-six-month clinical study
Daniel Barolet MD, Dermatologist, University of Montreal, Montreal, Canada
Despite the impressive clinical results that have been reported with the use of laser hair removal systems, long-term
comparative studies have been scarce. The purpose of this study was to evaluate over a thirty-six-month period the lasting
effects of the F1 Pulsed Diode Laser™ System on hair reduction.
With a wavelength of 810 nm, the F1 Diode Laser™ offers excellent follicular melanin absorption without the need for
increased fluence, and can safely treat a wide range of skin types (I-VI), with minimal pain. Moreover, its long-pulse
duration (15-40 msec) ensures deep follicular destruction. Results from the F1 Diode Laser™ twelve-month clinical study
were previously presented at the ASLMS (American Society for Laser in Medicine and Surgery) meeting in Reno, Nevada,
in April 2000 by Dr. Barolet (Barolet D. Comparison of two infrared laser systems for hair removal, Lasers Surg Med.,
Supp. 12, 2000, p.20). Herein, the thirty-six-month clinical study (1999-2002) clearly demonstrates permanent hair reduction
following treatments with the F1 Diode Laser™, assessing both security issues and overall efficacy of the device, up to
three years after treatment.
IRB Services (FDA approved independent ethical review committee) reviewed the ethical aspects of the study. A total of
seventeen (17) patients were recruited and informed consent was obtained after explanation of study design and potential
Patient pretreatment evaluations included medical checkup, review of enrolment inclusion/exclusion criteria, and
determination of skin type (Fitzpatrick scale I-VI).
• Large 2 x 3 cm test sites (13) were mapped on the upper back (male) and posterior aspect of thigh (female) of N=17
patients, with skin type I-V (fair to dark-skinned) and any hair color. Each test site was shaved before laser exposure and
treated for 1, 2, 3 or 4 times at one-month intervals, with 15, 20 and 25 Joul