ROUGH DRAFT/OUTLINE (for independent irb)
from Suggested Guidelines for Writing a Research Proposal
11/24/09
Cover Sheet
Single Blind Study of the LaserCap as a low level laser hair re-growth device (half-head illumination protocol)
Study #1
Sponsor and Medical Monitor:
Michael Rabin, M.D., M.B.A., CEO bio
Transdermal Cap, Inc.
938 Chestnut Run
Gates Mills, OH 44040
440-423-1836
begin_of_the_skype_highlighting 440-423-1836 end_of_the_skype_highlighting
Principal Investigator and Primary Research Site Address:
Robert Haber, M.D. bio
Haber Dermatology & Cosmetic Surgery
14077 Cedar Rd
South Euclid, OH 44118
216-932-5200
begin_of_the_skype_highlighting 216-932-5200 end_of_the_skype_highlighting
Purpose of the Study
This study is to determine the efficacy of the LaserCap as a low level laser hair re-growth device. Specifically, the LaserCap will be evaluated using patients with early hair loss and no other previous hair re-growth treatments to determine if LaserCap use results in an increased number of new hairs in the treatment area versus the control area (moving hair follicles from telogen into anagen) and/or an increased diameter of existing hairs in the treatment area versus the control area (improving the anagen phase). Each patient will serve as his or her own control as the LaserCaps used for the clinical trial will illuminate on the left or the right only. A precise laboratory photomicrographic hair count and hair shaft density measurement protocol will be used that should have the sensitivity to determine even single tiny vellus hair count and/or cross-sectional area differences. The principal investigator and the professionals performing the photomicrographic hair counts and hair shaft density measurements will be blinded. Patients will not be blinded as they have the ability to know which side of the LaserCap is illuminated..
predicate
device - lasercomb study for 510 (k) clearance
supporting science
powerpoint from mike hamblin
lasercap
comparison chart with the predicate lasercomb device
hamblin
white paper on lllt for hair re-growth
Criteria For Subject Selection
Number of subjects: 50 to 100 recruited from 1 to 4 sites
Gender of Subjects: 1/2 women and 1/2 men
Age: 18-55
Racial and Ethnic Origin: no discrimination
Inclusion Criteria: Referred by a hair restoration physician with early thinning hair where subject and/or physician describe noticeable thinning for <=10 years
Exclusion Criteria: any previous treatment for hair loss in the past year; also, at the discretion of the primary investigator
Vulnerable Subjects: at the discretion of the primary investigator
Methods and Procedures:
Methods and Procedures
1. male and female patients with early thinning hair and no previous
treatment will be selected.
2. each patient will be instructed to have their hair cut, if desired, just
prior to the start of the study, since no hair cuts will be allowed during the
study period which may be up to 6 months for each patient. after optional hair
cut, general hair length will be measured and documented at 6 places on the
scalp, as in half
head illumination diagram
3. each patient will be assigned a number and will be given a lightcap with
corresponding number that illuminates either on the left or right half
head illumination lasercap, along with a powerpack, charger, and
instructions for home use. each patient will keep a log of home use with date,
start time, end time, verification of illumination at the start and end or each
daily treatment (e.g., 45minutes/day 7 days/week; missed treatments should be
documented).
4. at 90 days into the study, hair will be analyzed according to the "hair
analysis method" .
5. the study may be terminated at 90days on a patient-by-patient basis if
results from the hair analysis method indicate a desired effect; if not, then
the study will continue for another 90 days with a repeat of step #4
List of above Methods and Procedures links:
half head illumination lasercap
half head illumination diagram
LaserCap operating procedure:
1. charge powerpack (powerpack switch is off; charger light will go from red to
green with powerpack is charged)
2. put lasercap in hat (and keep it there for the duration of the 6 month study)
3. put hat on head
4. plug in powerpack to hat
5. flip switch to on
6. tip hat up in the mirror briefly to verify lights are on (no eye safety issue
beyond 50cm (20 inches))
7. wear 45 minutes/day 5-7 days/week (document missed days)
8. when done, repeat #6 to verify lights are on
9. keep a log of treatments (date, start time, end time, comments)
Data Analysis and Data Monitoring: The 'hair analysis method' described above will be the sole measurement process used to determine the extent, if any, of hair re-growth. At 90 days into treatment, and again at 180 days into treatment, if needed, hair bundles representing roughly 1cm diameter areas of the scalp in treatment and control locations will be secured with a tiny rubber band at the base of the bundle (i.e., close to the scalp) and trimmed with a scissors, just below the rubber band and as close to the scalp as possible. Each bundle will be separately bagged and labeled with the patient #, date,either LEFT or RIGHT, and either FRONT and CROWN, along with the original hair length measured at the beginning of the study in that region. Bags with hair bundles will be sent to the hair analysis lab where hair counts and cross-sectional areas will be automatically obtained using well established shape recognition algorithms and verified by human examination, from a comprehensive 100x magnification hair bundle cross section at the beginning of treatment (bundle length minus original hair length at the beginning of treatment) and a corresponding cross section at the base of the bundle, which represents the closest representation to the treatment effect without the need for biopsy (it may lag around 15-30 days from the actual treatment effect since the hair follicle originates around 3mm deep and the base will probably be cut a few millimeters from the scalp. if hair growth is around 1cm/month then this represents about 1/2 month lag)
The data will be made available to an independent group who will analyze it with standard statistical processes where all data (patient#, specimen date, hair count and area data at the start, hair count and area data at the data at the base, etc.) will be input and intrabundle differences will be compared between LEFT and RIGHT at FRONT or CROWN. This data may then be sent to another independent group who can then match the patient# with the treatment device and determine if statistically significant differences exist between the LEFT and RIGHT sides and whether they can be attributed positively to the LaserCap.
Data Storage and Confidentiality: All data will be stored at the hair analysis lab and will remain anonymous as the lab only has patient numbers without the corresponding lookup table.
Transition from Research Participation: All subjects will receive a free consultation from their referring hair restoration physician, and will receive a full-head illumination LaserCap for 6 months from their end of study date free of charge, if they desire it.
Risk/Benefit Assessment:
Risk Category: Minimal
Potential Risks: There is a laser eye safety risk (class3R 5MW red; same as a common red laser pointer that is sold without restriction; and see LaserCap risk ). There is a potential psychological risk to participants since they will be receiving treatment only on one side of their scalp. There is a mild amount of heat generated from the LaserCap when in use that may be noticeable as a warm sensation on the scalp during treatment.
Protection against Risks: The LaserCaps are properly labeled regarding the eye safety risks and patients will be instructed to not stare into the lights for any length of time beyond a few seconds while the LaserCap is operating. Regarding the potential psychological risk of half head treatment, patients will be monitored closely, and, at the 1st sign of any noticable interside difference in hair density then hair counts will be take, and, if statistically significant, then the patient will be terminated from the study and offered a full treatment plan if indicated. Patients will be instructed to remove the LaserCap if it becomes uncomfortable at any time during any treatment session (hot, itchy, etc.) and immediately report this to the principal investigator for recommendations.
Potential Benefits to the Subjects: Subjects will take part in determining if the LaserCap can help their hair loss.
Alternatives to Participation: There are a number of medical, surgical, and cosmetic alternatives for treatment of hair loss that do not include use of low level laser treatment. In addition, potential subjects may prefer a full-head illumination LaserCap, rather than a half-head illumination LaserCap and it may be possible to offer it but without the support of a medical claim of hair re-growth.
Subject Identification, Recruitment and Consent/Assent:
Method of Subject Identification and Recruitment: Local ads will be placed for participants with early thinning hair. They will respond confidentially by phone or email and will be given a brief questionaire to evaluate their hair loss and determine eligibility.
Process of Consent: standard
Subject Capacity: standard
Subject/Representative Comprehension: standard
Debriefing Procedures: not applicable
Consent Forms: standard
Documentation of Consent: the PI will keep a record
Costs to the Subject: a deposit on the half-head illumination LaserCap will be required to ensure that the patient will return it at the completion of the study.
Payment for Participation: free use of a full-head illumination LaserCap for a period of 6 months after completion of the study.
