LaserCap™ Clinical
Studies in women and men with thinning hair:
Hair Re-growth: Clinical Study of LaserCap™ as a hair re-growth device in women and men with thinning hair. This study aims to demonstrate LaserCap’s ability to cause dormant Telogen Phase hair follicles to cycle to Anagen Phase growth.
Hair Shaft Thickening: Clinical Study of LaserCap™ as a hair thickening device in women and men with thinning hair. This study aims to demonstrate LaserCap’s ability to improve the Anagen Phase growth of hair follicles, resulting in increased hair shaft thickness and/or a reduction in hair shaft thinning. Hair pigment will also be assessed.
Hair Growth Rate Increase: Clinical Study of LaserCap™ as a device to increase hair growth rate. This study aims to demonstrate LaserCap’s ability to improve the Anagen Phase growth of hair follicles, resulting in an increased rate of hair growth.
Hair Length Increase: Clinical Study of LaserCap™ as a device to grow hair longer. This study aims to demonstrate LaserCap’s ability to prolong the Anagen Phase growth of hair follicles, resulting in longer hair.
Combination Treatment Studies: Each of the above with combination LaserCap™ and topical pharma hair re-growth agent(s) (i.e., Liquid & Light Rx).
LaserCap™ Clinical
Studies in women and men undergoing hair transplant procedures:
Increased Hair Transplant Follicle Survival: Clinical Study of LaserCap™ as a device to increase the survival of transplanted hair follicles. This study aims to demonstrate LaserCap’s ability to increase the survival of transplanted hair follicles by pre-transplant treatment of the donor site with LaserCap™.
Reduced Donor Hair Shedding after Hair Transplant: Clinical Study of LaserCap™ as a device to reduce post-transplant donor hair shedding. This study aims to demonstrate LaserCap’s ability to reduce the number of donor hairs that shed after hair transplant by post-transplant treatment of the recipient site with LaserCap™.
Increased Hair Transplant Follicle Survival and Reduced Donor Hair Shedding after Hair Transplant: Clinical Study of the combination of pre- and post-transplant treatment with LaserCap™.
Study Notes: Low Level Laser
Treatment has been shown to be safe (Appendix A). Low Level
Laser Treatment has been shown to be effective (Appendix B). LaserCap™
has been shown to be a non-significant-risk low level laser treatment device
(Appendix C). All eligible study subjects must complete the
pre-study questionnaire (Appendix D). All eligible study
subjects must sign the consent form (Appendix E). Study
subjects will receive either a full-head illumination LaserCap or a half-head
illumination LaserCap™ for as much as daily home use of 30-60 minutes, and
will keep a written log of usage and comments. Subjects will
be instructed to not use any other hair re-growth treatments during the study
period. Subjects will agree to mail in to the study’s Hair
Analysis Lab, tiny samples of around 25-50 clipped hairs at around 0, 60, 120,
and 180 days of the study; these tiny hair samples will be clipped from front
and crown treatment areas and low-occiput or side control area, and thus, all
subjects will serve as their own control. (Appendix F) [Those on half-head
illumination LaserCaps could be switched to full-head illumination as early at
60 days, if Hair Analysis Lab results show a significant difference between
treatment and control side. In addition, (blinded) subjects
with full-head/low-intensity (10% of the treatment dosimetry) LaserCaps will
serve as an additional control group]
Study Costs: Each
LaserCap™ study cost is substantial and is estimated at around
$__________/subject on average, including LaserCap™ use. There
is some funding to cover some costs; however, subjects using full-illumination
LaserCaps over the 6 month study periods may be asked to bear up to $_________
over 6 months to cover a portion of these study costs.
About the Company and
LaserCap™: Transdermal Cap, Inc. was formed in 2006 by co-inventors Michael
Rabin, MD and M.I.T.-trained optical physicist David Smith, PhD, in
collaboration with Harvard-based photomedicine expert Michael Hamblin, PhD and
internationally acclaimed hair restoration physician Robert Haber, MD, to
develop innovative light-based devices for the Global Beauty & Health
Industries. Its first commercial product is LaserCap™ for women and men
with thinning hair or at risk for thinning hair, a condition that affects up to
50% of adult women and 80% of adult men. LaserCap™
represents a quantum leap in low level laser treatment for thinning hair as it
provides a portable (battery powered) and
wearable-under-any-hat, home-use device that delivers >2x the low-level light
power of $50,000 retail physician-office laser dome devices;
this dosimetry level is thought to be essential for maximum
effectiveness. Furthermore, the in-office laser dome
treatments may cost patients up to $5,000 over 52 weeks and require them to
visit the physician office at least 2x/week over the 52 week period, whereas
LaserCap™ will be priced considerably less, and its portability & home-use
convenience make compliance a non-issue.
Patents
Pending / Copyright 2009 / Transdermal Cap, Inc. /