NCT01686295

24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Freedom Laser Therapy, Inc. · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DEVICE	iRestore Hair Rejuvenation System	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 3 times a week for 30 minutes on non-consecutive days
DEVICE	sham device	This shame device will be a sham comparator 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 3 times a week for 30 minutes on non-consecutive days

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-09-18
• Last updated: 2012-09-18

Locations

1 site across 1 country: United States