24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness
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
Device: iRestore Hair Rejuvenation System
Device: sham device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Change from Screening/Baseline Hair Growth at Week 12 and Week 24 [ Time Frame: Screening/Baseline, Week 12, and Week 24. The hair will be clean and properly combed for each individual in the following manner ] [ Designated as safety issue: Yes ]
Standardized global scalp photographs will be taken of each subject prior to hair clipping for hair count macrophotography. These photographs will be obtained at Screening/Baseline, Week 12, and Week 24.To determine any differences from baseline photos.
- Frontal (male only) and Top Scalp Views (female only): Hair will be center-parted and combed away from the part.
- Vertex View (male only): Hair will be combed away from the center of the vertex like the spokes of a wheel.
Global scalp photographs will be sent to Canfield Scientific, Inc. a central core lab for study imaging.
- Visual Scalp Assessment [ Time Frame: At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee ] [ Designated as safety issue: Yes ]
At Baseline, Week 4, Week 12, and Week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee for any sign of irritation or dermatologic conditions (eg, erythema, edema, dryness, scaling). The grading scale provided in Table 5 will be used to categorize each condition:
Table 5: Visual Scalp Assessment Scale SCORE RESPONSE 0 None
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: iRestore Hair Rejuvenation System
Seventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device
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
Other Name: iRestore Hair Rejuvenation System
Sham Comparator: Sham Device Arm
This study arm will use a sham device consistent with the experimental device with 12 men and 12 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
Other Name: iRestore Hair Rejovenation System
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686295
|United States, New Jersey|
|TKL Research Inc.||Recruiting|
|Paramus, New Jersey, United States, 07652|
|Contact: C Andresen 201-587-0808 email@example.com|
|Principal Investigator: Jonathan Dosik, M.D.|
|Principal Investigator:||Jonathan Dosik, MD||TKL Research, Inc.|