The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively perform self-use application by following written instructions.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Hilltop Research
St. Petersburg, Florida, United States
NYU School of Medicine
New York, New York, United States
Difference in terminal hair count in the target region
A circular haircount target area approximately 1.9 cm in diameter will be identified between 10 and 2 o'clock in the leading edge of an actively balding area of the vertex. The target area will be clipped short (approximately 1 mm in length). A small dot tattoo will be placed in the center of the target area and will be used as a reference point. The same circular haircount area will be clipped and photographed at subsequent study visits. All hairs \>30 μM will be classified as terminal hairs. The number of terminal hair counts (n/cm2) and width of terminal hairs (μM/cm2) in the hair count area will be measured at the baseline, subsequent study visits and at 26 weeks.
Time frame: 26 weeks
Subject's static self global assessment of hair regrowth
Subject will report on the following questions, on the following scale: Not at all, Slight Improvement, Moderate Improvement, Good Improvement, Greatly Improved Has your rate of hair loss slowed down? Do your believe your hair is growing faster? Does your hair feel thicker or fuller? How would you rate the overall improvement of your hair? The following question will use this scale: No growth, Minimal Growth, Moderate Growth, Dense Growth How would you rate your overall hair regrowth?
Time frame: 26 weeks
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