Androgenetic Alopecia Clinical Trial
Official title:
A Randomized, Double -Blind,, Sham-Device-Controlled, Multicenter, 24-Week Clinical Trial to Evaluate the Safety and Effectiveness of the iRestore ™ Hair Rejuvenation System in the Treatment of Male and Female Androgeneticalopecia
The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia
The test treatment is the iRestore™ Hair Rejuvenation System. The device irradiates the
scalp with visible light using 5 mW (class 3a) lasers. It is to be used approximately 3
times per week for approximately 30 minutes at each session.
The System is placed on the head and adjusted to a comfortable size by rotating knobs on the
side of the device. If needed, subjects may replace the soft pad on the inside of the device
with the thinner pad provided. There will be 2 options for using the product. The subject
will either insert the 5-V AC power adapter pin into the device remote control, and the 5-V
adapter will then be plugged into the AC outlet; or the subjects will use the rechargeable
battery pack and belt clip. The battery pack is an external device which will allow the
subject the freedom of mobility while treating the hair. The rechargeable battery pack will
hold a charge for up to 3 hours prior to needing to be recharged. The iRestore™ remote
control clips into the battery holster and the pack plugs into the remote. The battery pack
can be placed in a pocket, clipped to the belt or placed next to the subject. The device
will be turned on by pressing the power button on the remote control. The dome of the device
is to be moved forward and backward by the subject to brush through the hair and increase
the direct light which comes into contact with the scalp. Subjects will then position the
dome at the front of the scalp and press the start button to begin a 10-minute session.
Note: As a safety feature, the dome must be placed onto the head prior to starting the
device. A timer will indicate the completion of the session with a beep sound. Subjects will
complete the same process as done with the front of the scalp with the dome repositioned to
the middle of the scalp and then the back of the scalp. Once all 3 positions have received
the 10 minute treatment, the power button is to be held for approximately 3 seconds to turn
the device off. Once off the device is to be unplugged from the wall.
The control device will be identical to the test device except that the laser-emitting units
will be disabled. A standard light will be emitted from the device. Subjects and clinical
staff engaged in the performance of assessments will be treatment blinded.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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