Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
Phase: NA
Conditions: Androgenetic Alopecia
Sponsor: GID BIO, Inc.

 
 
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Adipose-derived Stromal Vascular Fraction Injections to Stimulate 
Hair Regrowth for Androgenetic Alopecia 
PROTOCOL: GIDAA-01 Rev: D  
 
Study Sponsor:  
The GID Group, Inc. 
 
901 Front St., Suite 240 
 
Louisville, CO 80534 
 
Sponsor Contact 
Director of Clinical Affairs 
 
 
 
Date: 
March 24, 2016 
 
 
The study will be conducted in accordance with the design and specific provisions of this IRB 
approved protocol, in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP) and the 
applicable regulatory requirement(s). The Principal Investigator will assure that no deviation 
from, or changes to; the protocol will take place without prior agreement from the sponsor and 
documented approval from the IRB, except where necessary to eliminate an immediate hazard(s) 
to the trial participants. The Principal Investigator will promptly report to the IRB and the sponsor 
any changes in research activity and all unanticipated problems involving risk to human subjects, 
or others.  
 
I have read and agree to follow the procedures as outlined in this protocol. 
 
 
                                                                     
____________________ 
  Signature of Investigator 
Date  
 

 
 
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SUMMARY 
 
Objectives: 
The general objective of this study is to conduct a safety and feasibility 
study of a single injection of autologous adipose-derived SVF for the 
treatment of alopecia.  
Specific Objectives 
1. Safety - Adverse Events 
2. Feasibility – Pre-op to post-op hair density (number of hairs per 
square centimeter) and hair thickness 
Design: 
This is a prospective, non-randomized, non-blinded, interventional, 
consecutive series, multiple site study to determine initial safety and 
feasibility of a single injection of autologous adipose-derived SVF for the 
treatment of alopecia.   
Subject Population:  Inclusion Criteria:  
1. Males and females 18 - 60 years of age that have been diagnosed 
with androgenetic alopecia.   
2. Subjects will be in good health (ASA Class I-II) with a BMI < 35. 
3. Must have at least a 2cm x 2cm spot on the scalp which shows 
evidence of alopecia without scarring or traumatic injury 
4. Able and willing to make the required study visits.  
5. Able and willing to give consent and follow study instructions. 
6. Must speak, read and understand English 
 
Exclusion Criteria: 
1. History of bleeding disorders, anticoagulation therapy that cannot 
be stopped 14 days prior to injection  
2. Allergic to lidocaine, epinephrine, valium or sodium phosphate 
3. Individuals with a propensity for keloids 
4. Individuals with diminished decision-making capacity will not be 
included in this research study. 
5. Current use of anti-inflammatory or anticoagulation medications 
that affect bleeding or are for bleeding disorders. These include: 
Plavix, Warfarin (Coumadin, Jantoven, Marfarin).   
6. Use of concomitant treatments, including topical medications, oral 
medications, meso-therapy, non-ablative fractional laser treatment, 
low-level laser therapy, interfollicular PRP injection and hair 
transplantation within the preceding 6 months.  
7. All smokers and other tobacco users. 

 
 
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Subject 
Recruitment 
Methods:  
Subjects will be recruited from the practice of the Principal Investigator 
(PI) at each site and/or other colleagues and healthcare professionals in 
the community. Recruitment will be prospective for this study. Subjects 
will be recruited via; 1) email utilizing a list of patients that have given 
their prior consent to be contacted in this manner 2) at the PI’s office 
when they come in for their regularly scheduled appointments or 3) 
referrals from healthcare professionals within the community or 4) via 
IRB approved flyers. 
Investigational 
Sites 
Up to 3 sites 
Estimated Total 
Sample Size 
Eight (8) subjects will be recruited to participate in the study. This study 
is a small pilot safety and feasibility study not requiring sample size. 
Plan for Data 
Analysis: 
Adverse events will be recorded.  Hair density (hairs per square 
centimeter) and hair thickness will be compared pre and post 
treatment. 
 
 
 

 
 
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Table of Contents 
1 
Introduction .......................................................................................................................................... 6 
2 
Study Objectives ................................................................................................................................... 6 
3 
Study Design.......................................................................................................................................... 6 
4 
Study Population ................................................................................................................................... 7 
4.1 
Subjects ......................................................................................................................................... 7 
4.1.1 
Inclusion Criteria ................................................................................................................... 7 
4.1.2 
Exclusion Criteria ................................................................................................................... 7 
4.2 
Study Site Selection ....................................................................................................................... 7 
4.3 
Concomitant Medications ............................................................................................................. 7 
5 
Study Visits and Methods ..................................................................................................................... 9 
5.1 
Study Measurements .................................................................................................................... 9 
5.1.1 
Safety .................................................................................................................................... 9 
5.1.2 
Feasibility .............................................................................................................................. 9 
5.2 
Study Visit and Procedures ........................................................................................................... 9 
5.2.1 
Visits ...................................................................................................................................... 9 
5.2.2 
Recruitment ........................................................................................................................ 10 
5.2.3 
Informed Consent & HIPAA ................................................................................................. 10 
5.2.4 
Enrollment ........................................................................................................................... 11 
5.2.5 
Study Timeline..................................................................................................................... 11 
5.2.6 
Methods .............................................................................................................................. 11 
5.2.7 
Adverse Events .................................................................................................................... 12 
5.2.8 
Data Collection .................................................................................................................... 12 
5.2.9 
Case Report Forms .............................................................................................................. 12 
5.2.10 
Data Management and Quality Control .............................................................................. 12 
5.3 
Subject Exit and Study Completion Procedures .......................................................................... 13 
5.3.1 
Subject Exit Status ............................................................................................................... 13 
5.3.2 
Completed Study ................................................................................................................. 13 
6 
Side Effects, Adverse Events and Other Risks ..................................................................................... 13 
7 
Statistical Analysis ............................................................................................................................... 14 

 
 
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7.1 
Sample Size ................................................................................................................................. 14 
7.2 
Statistical Methods ..................................................................................................................... 14 
7.3 
Procedure for Accounting for Missing, Unused or Spurious Data .............................................. 14 
8 
Ethical and Regulatory Considerations ............................................................................................... 14 
8.1 
Institutional Review Board .......................................................................................................... 14 
8.2 
Protocol Reviews ......................................................................................................................... 14 
8.3 
Protocol Amendments ................................................................................................................ 15 
8.4 
Subject Information and Informed Consent ............................................................................... 15 
8.5 
Study monitoring ........................................................................................................................ 15 
8.6 
Additional Considerations ........................................................................................................... 15 
9 
References .......................................................................................................................................... 16 
 
 
 

 
 
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1 Introduction 
Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of 
Caucasian men and women, respectively, over the age of 50.  The percentage of men and women 
affected over the age of 70 increases to 80% and 60% of Caucasian men and women, respectively 1,2. 
Although alopecia is considered a minor dermatologic condition, it is seen as a serious condition 
with major life consequences by those with alopecia and has been associated with increased 
incidence of myocardial infarction, hypertension and hypercholesterolaemia3 4.    Androgenetic 
alopecia is associated with feelings of anxiety, depression and various personality disorders among 
men and women due to physical appearance3-6. Depression, anxiety, aggressiveness, impaired 
quality of life and social inadequacy have been documented.  The presence of alopecia in women is 
particularly stressful5,7.  
Human Clinical Studies 
Two studies have recently been published that used adipose-derived SVF cells for hair regrowth in 
humans and have found it to be safe and effective.   Shin et al retrospectively examined 27 women 
who received 12 injections (one injection per week) of adipose-derived SVF for treatment of 
alopecia8.  After 12 weeks hair density and thickness significantly increased with no adverse events 
reported.   
Fukuoka et al reported on 2 groups of patients with alopecia9.  One group had 11 men and 11 
women that were treated with 6 injections spaced every 3 to 5 weeks of adipose-derived SVF and 
monitored for up to 7 months.  They found a significant increase in hair growth and reported no 
adverse events or safety issues.  In the second group 10 patients (8 men and 2 women) were treated 
on one side with adipose-derived SVF and the other with placebo (saline).  Patients were blinded to 
the treatment. This group also received 6 injections similar to the other group.  The treatment group 
had significantly more hair growth than the control side.   
A hair regeneration procedure that is less invasive than surgical hair transplantation, entails less risk 
than current surgical treatments, and is less time consuming would benefit men and women with 
alopecia.   
2 Study Objectives 
The general objective of this study is to conduct a safety and feasibility study of a single injection of 
autologous adipose-derived SVF for the treatment of alopecia. 
3 Study Design 
This is a prospective, non-randomized, non-blinded, interventional, consecutive series, multiple site 
study to determine initial safety and feasibility of a single injection of autologous adipose-derived 
SVF for the treatment of alopecia. 

 
 
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4 Study Population 
4.1 Subjects 
A total number of eight (8) subjects from a single population, i.e., patients who have been 
diagnosed with androgenetic alopecia, will be recruited. 
4.1.1 Inclusion Criteria 
1. Males and females 18 – 60 years of age and older that have been diagnosed with 
androgenetic alopecia.   
2. Subjects will be in good health (ASA Class I-II) with a BMI < 35.  
3. Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia 
without scarring or traumatic injury 
4. Able and willing to make the required study visits.  
5. Able and willing to give consent and follow study instructions. 
6. Must speak, read and understand English 
4.1.2 Exclusion Criteria 
1. History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 
days prior to injection  
2. Allergic to lidocaine, epinephrine, valium or sodium phosphate 
3. Individuals with a propensity for keloids  
4. Individuals with diminished decision-making capacity will not be included in this 
research study 
5. Current use of anti-inflammatory or anticoagulation medications that affect 
bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, 
Jantoven, Marfarin).  In addition, if any of the following medicines are used two (2) 
weeks prior to surgery the patient will be ineligible. 
6. Use of concomitant treatments, including topical medications, oral medications, 
meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, 
interfollicular PRP injection and hair transplantation within the preceding 6 months. 
7. All smokers and other tobacco users.   
4.2 Study Site Selection 
A maximum of three sites will participate in clinical data collection.  The subjects will be divided 
equally among the sites as much as possible.   
4.3 Concomitant Medications 
If the subject is taking any medications on this list, it should be discontinued two (2) weeks 
prior to surgery, and only Tylenol should be taken for pain. All other medications must be 

 
 
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specifically cleared by the doctor prior to surgery. It is absolutely necessary that all current 
medications be specifically cleared by the doctor and the nursing staff. 
ADVIL 
ALCOHOL 
ALEVE 
ALKA SELTZER (EFFERVESCENT 
Tablet) 
ALKA SELTZER (COLD MEDICINE 
Tablet) 
ANACIN TABLETS AND CAPLETS 
(MAXIMUM STRENGTH) 
ARTHRALGEN TABLETS 
ARTHRITIS STRENGTH BUFFERIN 
TABS 
ARTHROPAN LIQUID 
ARTHROTEC 
ASA TABLETS ENSEALS 
ASCRIPTIN WITH CODEINE 
ASCRIPTIN TABLETS 
ASCRIPTIN AD TABLETS 
ASCRIPTIN EXTRA STRENGTH 
ASPIRBUF TABLETS 
ASPERGUM 
AXOTAL TABLETS 
BAYER ASPIRIN TABLETS 
BAYER CHILDREN’S COLD TABLETS 
BAYER CHILDREN’S ASPIRIN TABLETS 
BC TABLET AND POWDER 
BUFF-A COMP #3 TABLETS WITH 
CODEINE 
BUFFAPRIN TABLETS 
BUFFERIN TABLETS 
BUFFERIN ARTHRITIS STRENGTH 
TABLETS 
BUFFERIN EXTRA-STRENGTH 
TABLETS 
BUFFERIN WITH CODEINE #3 
TABLETS 
BUFFETS II TABLETS 
BUF-TABS 
CAMA ARTHRITIS PAIN RELIEVER 
CELEBREX 
CODEINE 
CONGESPRIN CHEWABLE TABLETS 
COPE TABLETS 
COSPRIN TABLETS 
COUMADIN 
CP-2 TABLETS 
DARVON WITH ASA PULVULES 
DARVON COMPOUND PULVULES 
DARVON COMPOUND 65 
DARVON N WITH ASA 
DASIN CAPSULES 
DAYPRO 
DINOL TABLETS 
DISALCID CAPSULES 
DOAN’S PILLS 
DUOPRIN’S SYRUP 
DUOPRIN CAPS 
DURADYNE TABLETS 
DYNOSAL TABLETS 
EASPRIN 
ECOTRIN TABLETS 
EFFICIN TABLETS 
EFFICIN WITH CODEINE TABLETS 
EQUAGESIC TABLETS 
EXCEDRIN TABLETS AND CAPS 
EASPRIN 
ECOTRIN TABLETS 
FENOPROFEN 
FIORINAL TABLETS 
FIORINAL WITH CODEINE 
FOUR-WAY COLD TABLETS 
GAYSAL-S TABLETS 
GEMISIN TABLETS 
GOODY’S HEADACHE POWDER 
HYDROCODONE (VICODIN, LORTAB, 
NORCO) 
IBUPROFEN 
INDOMETHACIN 
INDOCIN 
INDO-LEMMON CAPSULES 
LANORINAL TABLETS 
MAGAN TABLETS 
MAGSAL TABLETS 
MARNAL CAPS 
MAXIMUM BAYER ASPIRIN 
MEASURIN TABLETS 
MEDIPREN 
MEFENAMIC ACID 
MIDOL CAPLETS 

 
 
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METHOCARBAMOL WITH ASPIRIN 
TABLETS 
MECLOMEN 
MECLOFENAMATE 
MICRAININ TABLETS 
MOBDIN TABLETS 
MOBIGESIC TABLETS 
MOMENTUM MUSCULAR BACKACHE 
MOTRIN, FORMULA TABLETS 
NALFON 
NAPROSYN 
NAPROXEN 
NEOCYLATE TABLETS 
NORGESIC & NORGESIC FORTE 
TABLETS 
NUPRIN 
ORUDIS 
OS-CAL GESIC TABLETS 
PABLATE 
PABLATE-SF TABLETS 
PEPTO BISMOL TABLETS AND 
SUSPENSION 
PERCODAN & PERCODAN-ASA DEMI 
TABLET 
PERSISTIN TABLETS 
PLAVIX 
PROPOXYPHENE COMPOUND 65 
PIROXICAM (FELDENE) 
PLAVIX 
ROBAXISAL TABLETS 
RUFEN 
S-A-C TABLETS 
ST. JOESPH ASAPIRIN FOR CHILDREN 
ST. JOESPH COLD TABLETS FOR 
CHILDREN 
SINE-OFF SINUS MEDICINE TABLETS 
SK-65 COMPOUND CAPS 
STANBACK TABLETS AND POWDER 
SUPAC CAPS 
SYNALGOS CAPS 
SYNALGOS-DC CAPSULES 
TALWIN COMPOUND TABLETS 
TRENDAR 
TOLECTIN 
TRIAMINICIN TABLETS 
TRIGSESIC 
TRILISATE TABLETS & LIQUID 
ULTRAM 
URACEL 
VANQUISH 
VERIN 
VITAMINE SUPPLEMENT 
VOLTAREN 
ZORPRIN TABLETS 
5 Study Visits and Methods 
5.1 Study Measurements 
5.1.1 Safety 
All adverse events will be recorded and evaluated for severity. 
5.1.2 Feasibility 
Before the procedure the density (number of hairs per square centimeter) and 
thickness (mm) of the hair will be measured and compared to the same 
measurements after the procedure at 3 and 6 months.   
5.2 Study Visit and Procedures 
5.2.1 Visits 

 
 
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There will be between 7 and 8 study visits for each subject (screening and pre-surgery 
1 may be combined). Each office visit will take approximately 0.5 hour.  The procedure 
visit will be conducted at the same center on an outpatient basis.   
5.2.2 Recruitment 
Subjects will be recruited via; 1) email utilizing a list of patients that have given their 
prior consent to be contacted in this manner 2) at the PI’s office when they come in 
for their regularly scheduled appointments 3) referrals from healthcare professionals 
within the community or 4) via IRB approved flyers.  Subjects recruited via email or 
flyer will be requested to call in for more information. Designated office staff will 
screen subjects in the office or on the phone to evaluate eligibility. 
5.2.3 Informed Consent & HIPAA 
The Consenting Process will only be done by the PIs or other qualified consent 
designees.  The PI or consent designee will conduct a complete interview for each 
potential Subject. The PI and authorized consent designees have clinical experience, 
have completed either CITI and/or NIH training “Protecting Human Research 
Participants”, and have individual expertise and training detailed in their respective 
curriculum vitae or resumes. 
The PIs and authorized consent designees will describe the project, its goals, 
expectations of the study, description of inclusion/exclusion criteria for the 
participants, the liposuction surgery, fat processing to obtain cells, scalp injections, 
events at the study visits, questionnaires to be used, that their participation has 
potential (but not guaranteed) direct medical benefit to them, and that the study may 
provide new knowledge relevant to potential use of cells or tissue therapies in the 
future.  Each subject must be informed that participation in the study is voluntary and 
that he/she may withdraw from the study at any time and that withdrawal of consent 
will not affect his/her subsequent medical treatment or relationship with the treating 
physician.   
The PI or consent designee will review the elements of HIPAA and Protected Health 
Information (PHI) with each participant and each participant will be asked if s/he 
understands HIPAA authorization and PHI.  Each participant will be asked to 
voluntarily sign a study Informed Consent Form and HIPAA Authorization Form before 
any study-related procedure is performed. The subject will sign the consent form if 
willing to proceed or decline any further participation if unwilling. Informed Consent 
Forms must be dated and signed by the PI or consent designee and participant or the 
participant’s legal representative and the original signed consent form kept by the 
Investigator in the study patient’s file.  “Legal representative” means an individual or 
judicial or other body authorized under applicable law to consent on behalf of a 

 
 
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prospective participant to the participant’s participation in the procedure(s) involved 
in the research. A copy of the signed consent documents will be provided to each 
subject. 
5.2.4 Enrollment 
The subject will be assigned an anonymous, unique identifier called the Subject ID 
unrelated to the subject’s name from a list of possible ID’s.  The subject’s name and 
corresponding identifier will be recorded in a study look up document, which shall be 
kept at the study site. 
The subject ID of excluded subjects will not be re-assigned.  Information describing the 
reason(s) for exclusion will be documented on the Inclusion/Exclusion CRF. 
5.2.5 Study Timeline 
Initial Contact to Informed Consent – The timing from the initial contact and obtaining 
consent at the Pre-surgery #1 is expected to range from the same day up to two (2) 
weeks depending on participant and physician availability. Potential Participants will 
have the option of taking additional time to review the documents, but it is expected 
that the dates for surgery will be set within two to four weeks depending on 
scheduling. A potential Participant will need to have all documents signed and in place 
prior to surgery and if they choose to participate in the project the study documents 
will be included in the package. 
5.2.6 Methods 
1. Liposuction will be performed at the clinical site according to standard clinical 
practice.   
2. The surgery and scalp injection will be conducted on the same day within 1.5 hours 
from collection of adipose to injection in the scalp.  
3. At the conclusion of the fat harvest procedures, support garments and dressings are 
worn by the Subject to control swelling and promote healing.   
4. Processing of the fat will be done immediately after harvest using a sterile single use 
disposable (GID SVF-2) and according to the instructions for use with the device.  
The GID SVF-2 is an investigational device and will be labeled as such. 
5. Injection of Cells into Scalp 
The scalp will be cleansed with 70% alcohol, and 1% lidocaine will be injected as a 
regional nerve block.  All of the SVF will be injected under the scalp at the superficial 
subcutaneous plane in a 2 x 2 cm area.   
6. Hair Measurements 

 
 
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Refer to the Hair Measurement CRF for location of 2 x 2 cm area.  Hair 
measurement will be made using a computerized handheld USB camera at baseline 
and 3 and 6 months after treatment.   
5.2.7 Adverse Events 
Although the actual study poses no threat or risk above that for the liposuction/fat 
harvesting procedure and scalp injection, any Adverse Event or Serious Adverse Event 
experienced by a participant involved in the study, whether or not due to the study, 
will be reviewed and evaluated for appropriate follow-up actions (see Adverse Events, 
Side Effects and Other Risks, Section 6). An Adverse Event Form or Serious Adverse 
Event Form will be filled out if such an event occurs and communicated directly to the 
Sponsor within 3 days. 
5.2.8 Data Collection 
The investigator will train his/her study personnel regarding the study protocol.  This 
training will take place prior to enrollment of the first subject.  The study site shall 
maintain applicable regulations specific to the conduct of clinical studies. Steps will be 
taken in the planning and implementation of this study to ensure that the data 
collected are accurate, consistent, complete and reliable. 
During the study, patient data paperwork will be kept using standard patient records 
criteria, confidentiality and information security procedures that include limited 
access, Co-PI oversight of records, and secured files.  The data will be stored 
consistent with the clinics Records Retention Policies.  
5.2.9 Case Report Forms 
All clinical data obtained will be recorded on source documents (i.e. study chart) and 
information required by the protocol will be copied onto the case report forms (CRFs).  
CRFs for each subject enrolled in the study will be stored in a binder.  The appropriate 
CRFs will be completed and signed by the PI.  All CRFs will be completed in a legible 
manner in ink.  Any corrections required will be made by drawing a single line through 
the incorrect entry, entering the correct information, and initialing and dating the 
change.   
During the study, the quality of the data will be assured by the presence of site 
personnel who will check the CRFs against the site's source documents for 
completeness and to ensure that data is collected in adherence to the protocol.  
Evident recording errors will be rectified by the clinical site. 
5.2.10 Data Management and Quality Control 

 
 
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A clinical study database will be generated by The GID Group, Inc. and/or by their 
representative to record all clinical data from the CRFs.  Deviations, discrepancies and 
missing data will be investigated.  After all protocol deviations and/or discrepancies 
are resolved and all corrections and clarifications are made to the database, the 
database is declared complete, accurate and locked. 
Any missing, unused, or spurious data will be noted in the study report.  Data may be 
disqualified if it meets the pre-determined exclusion criteria.  Selection of the 
acceptable subjects for data analyses will be established prior to the database lock.  A 
discussion of any outliers and reasons for excluding subjects or data will be 
documented and summarized in a study report. 
5.3 Subject Exit and Study Completion Procedures 
5.3.1 Subject Exit Status 
Subjects shall exit the study with a status as one of the following: 
1. Completing 
One who completes all required study visits. 
2. Non-completing 
a. One who exits the trial by his or her own volition or at the discretion of the PI.  
Any subject may decide to voluntarily withdraw from the trial at any time 
without prejudice. 
b. Non-completions are to be characterized as: 
i. One who does not complete all the study visits.  
b. The particular reason for non-completion should be documented on the CRF. 
3. Termination 
Subjects may be terminated from the study at the discretion of the PI only for 
reasons related to the study examinations that would jeopardize the subject’s 
health and/or welfare if they were to continue in the study. 
5.3.2 Completed Study 
The trial is completed when the planned enrollment has been completed, and the 
enrolled subjects exit the study. 
6 Side Effects, Adverse Events and Other Risks 
The Study adds no expected risks or the need for additional safety precautions for the Subject 
beyond what they would have for the standard Liposuction surgery and scalp injection. These are 
detailed in the INFORMED CONSENT - LIPOSUCTION (Suction-Assisted Lumpectomy Surgery) and the 
CONSENT FOR SCALP INJECTION PROCEDURE. 

 
 
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Throughout the course of the proposed study, all efforts will be made to remain alert to possible 
adverse events or untoward findings.  If an adverse event occurs, the first concern will be the safety 
of the subject.  Appropriate medical intervention will be made.  Any adverse events observed by the 
investigator or reported by the subjects, regardless of severity and whether or not ascribed to the 
research procedures, will be recorded in the appropriate section of the subject’s CRF. Any subjects 
who are terminated from the study due to adverse events will be followed until their medical 
outcome is determined.   
7 Statistical Analysis 
7.1 Sample Size 
This is a pilot study with a sample size of N=8 participants. 
7.2 Statistical Methods 
Hair density and thickness will be compared pre and post treatment. The data gathered will be 
used to establish a baseline difference for future studies.  
7.3 Procedure for Accounting for Missing, Unused or Spurious Data 
Any missing, unused, or spurious data will be noted in the study records.   Data may be 
removed if it does not meet quality criteria. 
8 Ethical and Regulatory Considerations 
This study must be carried out in compliance with the protocol and in accordance with the site’s 
standard operating procedures.  These are designed to ensure adherence to Good Clinical Practice 
(GCP) guidelines, as described in: 
• 
Code of Federal Regulations, Title 21, Parts 50, 56, and 812. 
• 
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research 
Involving Human Subjects 2013. 
• 
ICH E6 Good Clinical Practice April 1996 
The investigator agrees, when signing the protocol, to adhere to the instructions and procedures 
described in it and thereby to adhere to the principles of GCP to which it conforms. 
8.1 Institutional Review Board 
Initiation of this study requires approval by a qualified, properly constituted Institutional 
Review Board (IRB).  The protocol, proposed informed consent form and subject recruitment 
material must be included in this review process and approved.  A copy of the IRB approval will 
be kept in the study binder. 
8.2 Protocol Reviews 

 
 
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The study will not be started until the Protocol and the Consent Form have been approved by 
the appropriate IRB. It is the responsibility of the Investigator to keep copies of written 
approvals and a list of the members of the IRB, their titles and their institutional affiliations in 
the study binder. The approval should include study identification and the date of review. 
8.3 Protocol Amendments 
If the Investigator desires to modify the procedures and/or design of the study, he or she must 
contact and obtain the consent and approval regarding the proposed changes from the IRB, 
where applicable.   
8.4 Subject Information and Informed Consent 
It is the responsibility of the Investigator to ensure that each subject (or legally authorized 
representative) receives an explanation of the nature of the study, its purpose, the procedures 
involved, the expected duration, the potential risks and benefits involved and any discomfort it 
may entail.  Each subject must be informed that participation in the study is voluntary and that 
he/she may withdraw from the study at any time and that withdrawal of consent will not affect 
his/her subsequent medical treatment or relationship with the treating physician. 
It is the responsibility of the investigator at each study site to obtain a signed copy of the 
following consent documents from all subjects (as applicable) prior to enrollment into the 
study:  
• 
Subject Informed Consent and  
• 
HIPAA consent form  
 
The Investigator will acknowledge the receipt of informed consent documents by also signing 
the forms where designated.  A copy of each of the signed consent documents should be 
provided to the subject.  The original consent documents should be filed by each Investigator 
for possible review for study monitoring or auditing purposes.  Any changes to the informed 
consent and subject recruitment material must be approved by the IRB.  A copy of the 
approved version(s) must be kept in the study binder after IRB approval.   
8.5 Study monitoring 
The GID Group, Inc. will provide study monitoring to assure clinical research quality. 
8.6 Additional Considerations 
The proposed study is subject to all applicable governmental rules and regulations concerning 
the conduct of clinical trials on human subjects.  This includes, but is not necessarily limited to, 
the approval of an IRB (where applicable); obtaining prospective informed consent; monitoring 
of the conduct of the study and the completeness of the CRFs; and record retention in 
accordance with 21 CFR Part 812 Subpart G—Records and Reports. 

 
 
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It is the responsibility of each Investigator to obtain IRB approval of the study protocol and to 
keep the IRB informed of any serious side effects, any adverse events or any amendments to 
the protocol.   
All correspondence with the IRB will be filed in the study binder. 
9 References 
1. 
Ellis JA, Sinclair R, Harrap SB. Androgenetic alopecia: pathogenesis and potential for therapy. 
Expert reviews in molecular medicine. 2002;4(22):1-11. 
2. 
Yip L, Rufaut N, Sinclair R. Role of genetics and sex steroid hormones in male androgenetic 
alopecia and female pattern hair loss: an update of what we now know. The Australasian journal 
of dermatology. 2011;52(2):81-88. 
3. 
Rahnayake D, Sinclair R. Male Androgenetic Alopecia. In: De Groot LJ, Beck-Peccoz P, Chrousos 
G, et al., eds. Endotext. South Dartmouth (MA)2000. 
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