Conditions: Alopecia Areata
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
The investigators hypothesize that Restylane® could serve as a repair matrix which also maintains IL triamcinolone acetonide concentrations at higher levels for a longer period of time in the skin, giving a more sustained local anti-inflammatory effect and thus, arresting the AA process and promoting hair regrowth. Furthermore, the combination of Restylane® with IL triamcinolone acetonide injections may prevent a common side effect, atrophy. With the prevention of scalp atrophy and the preservation of higher concentrations of triamcinolone acetonide for longer periods of time, patients may see a better clinical response for a longer period of time. Quality of life may improve as the number of clinic visits decreases as would the number of IL corticosteroid injections.

Detailed description:

Arms:
arm 1: Injection of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on whole scalp and Restylane on half of scalp

Interventions: intervention 1: Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) intervention 2: Restylane
Intervention descriptions: intervention 1: Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp intervention 2: Intralesional injections of 2mLs of Restylane on one side of the scalp

Protocol document:
Prot_SAP_000.pdf: 
( 
vt1  
Department of Dermatology 
University of Minnesota 

 -.. () --- )-CH S-
Title of Study 
Safety and Efficacy of Combined Restylane® and Triamcinolone 
Acetonide 10 mg/cc lntralesional Injections for the Treatment of 
Alopecia Areata 
Purpose 
The purpose of this pilot research study is to determine the safety and 
efficacy of combined hyaluronic acid, Restylane®, and intralesional 
Triamcinolone acetonide 10 mg/cc in the management of alopecia 
areata. Dermal injections of Restylane® and triamcinolone acetonide 10 
mg/cc will be performed at areas of hair loss on study participants. 
Background 
AA is an autoimmune organ specific T-cell mediated disease which 
targets hair follicles and causes non-scarring hair loss5• Hairs that are 
shed are either in telogen or dystrophic anagen6• AA can present as 
patches of alopecia on the scalp, complete loss of hair on the scalp 
(AA total is) or loss of hair from the entire body (AA universal is) 1.
This fairly common disorder can affect patients of all ages8• Lifetime risk 
has been estimated to be 1.7%. A significant number of these cases, 
approximately 7%, may eventually evolve into chronic and severe hair 
loss8• Because the pathogenesis of the disease and the factors 
contributing to development are not fully understood, predicting the 
course of the disease is extremely difficult1. The psychological affects 
on patients with AA can be devastating. Increased risk of psychiatric 
disorders such as anxiety disorders (39%) and major depression (39%) 
have been found in patients affected by the disease3•
With regards to the management of AA, use of IL corticosteroids has 
become a first line therapy. Synthetic corticosteroids are utilized in 
Version 04/03/2013 
Restylane-Alopecia Areata study 
1 
NCT01797432



































ICF_001.pdf: 
 
 
 
 
 
 
 
 
IRB Code Number: 0907M69801; NCT01797432   
 
Version Date: 04/22/2014 
IRB Approval Letter Date: 11/17/2014 
 
Page 1 of 5 
CONSENT FORM 
 
Safety and Efficacy of Combined Restylane and Triamcinolone acteonide 
Injections for the Treatment of Alopecia Areata 
 
 
Sponsor: 
Medicis Pharmaceutical Corporation 
 
 
Site: 
Department of Dermatology 
 
 
University of Minnesota  
 
 
Principal Investigator: 
Maria Hordinsky, M.D.  
 
Study Team: 
Charles Crutchfield III, M.D. 
 
 
 
 
Ronda Farah, M.D. 
 
 
Heather Bemmels, M.S., C.G.C.  
 
 
 
 
 
 
 
 
You are invited to participate in a research study to examine whether the treatment you 
will be receiving for alopecia areata has an impact hair growth.  You are being asked to 
participate in the study because you have expressed interest in treatments for alopecia 
areata.  Your participation is completely voluntary. 
 
Before agreeing to participate in this study, it is important that you read this consent 
form.  This form may contain words that have not been explained well enough.  Please 
ask one of the study team to explain any information that is not clear.  You may take 
home an unsigned copy of this consent form to think about or discuss with family or 
friends before making your decision. 
 
This study is being conducted by Maria Hordinsky, M.D., Department of Dermatology, 
University of Minnesota. Other members of the study team are Dr. Ronda Farah, Dr. 
Charles Crutchfield, and Heather Bemmels, M.S., C.G.C., Clinical Research 
Coordinator in the Department of Dermatology at the University of Minnesota. 
 
Why is this study being done? 
 
The purpose of the study is to see whether treating alopecia areata with  injections of 
the corticosteroid, triamcinolone acetonide, with Restylane®, a dermal filler, has an 
impact on hair growth. 
 
Corticosteroids are powerful anti-inflammatory drugs similar to a natural hormone called 
cortisol that is produced by the adrenal glands.  Because corticosteroids suppress the 
immune system, they are often used in the treatment of various autoimmune diseases, 
including alopecia areata.  Injections of triamcinolone acetonide given directly into 
hairless patches on the scalp and sometimes the brow and beard areas are effective in 
halting alopecia areata and inducing hair growth in most people.  The drug removes the 


Restylane and Triamcinolone acteonide Intralesional Injections 
IRB Code Number: 0907M69801  
 
Version Date: 05/30/2014 
IRB Approval Letter Date: 11/17/2014 
 
Page 2 of 5 
confused immune cells and allows the hair to grow.  It usually takes about 1 or 2 months 
for new hair growth to become visible.  
   
Restylane, also known as Hyaluronic acid, is currently approved for use as a dermal filler 
for wrinkles of the face. It enhances the movement of cells involved in wound healing and 
provides a favorable environment for cells of the repair process to migrate.  
 
The purpose of this study is to examine whether there is an increase in hair regrowth in 
patients with alopecia areata when intralesional injections of Restylane are given with 
triamcinolcone acetonide when compared to intralesional injections of triamcinolone 
acetonide alone. No studies have been done to evaluate the effectiveness of combined 
Restylane and triamcinolone acetonide intralesional injections. 
 
What is involved in the study? 
 
If you agree to participate in this study, you will be asked about your medical history and 
other drugs that you are taking to make sure you are eligible for the study.  The study 
will involve receiving intralesional injections of Restylane and triamcinolcone 
acetonide at the bald areas of your scalp on one side. Triamcinolone acetonide will be 
injected alone to the bald areas on the other half of the scalp. Non- identifying 
photographs of the scalp will be taken at the first appointment and then at the second 
and third appointments to document changes in hair growth.  Because the drugs in this 
study may affect a fetus, pregnant women may not participate in this study.  If you are a 
female of child-bearing potential (i.e., you have had your first menstrual period and have 
not yet reached menopause), a urine test will be done at the initial visit and prior to the 
second injection to make sure you are not pregnant. 
 
How long will the study last? 
 
The study will last about 12 weeks.  At the first and second visits you will receive 
intralesional injections.  The visit will be scheduled approximately 6 weeks apart. 
Photographs will be taken at both visits. 
 
What are the possible risks? 
 
The risks of participating in the study include: 
 
Intralesional injections: Risks associated with the intralesional triamcinolone acetonide 
injections include dizziness, bleeding, bruising, pain, discoloration, inflammation, allergic 
reaction, death of tissue (necrosis), tenderness and, rarely, fainting, acne or the 
possibility of developing an infection at the injection site. 
 
In studies involving the use of Restylane® as a dermal filler for facial wrinkles infrequent 
reports of the following were made to the manufacturer: inflicted injury, stuffy nose 
(sinusitis), upper respiratory tract infection, acne, back pain, depression, tooth disorder, 
bronchitis, pneumonia, rash (contact dermatitis), allergic reaction, joint pain (arthralgia), 


Restylane and Triamcinolone acteonide Intralesional Injections 
IRB Code Number: 0907M69801  
 
Version Date: 05/30/2014 
IRB Approval Letter Date: 11/17/2014 
 
Page 3 of 5 
osteoporosis, headache, migraine, herpes simplex, high cholesterol, involuntary 
leakage of urine (urinary incontinence), , seasonal allergy, reaction to make-up around 
the eye.  
 
Are there any potential benefits? 
 
There are no direct health benefits to you from participating in this study, other than the 
possibility of hair regrowth.  It is possible that the information gained from your 
participation may help others with alopecia areata. 
 
What other options are there? 
 
You do not need to participate in this study to receive treatment for your alopecia 
areata.  Your doctor will discuss the various treatment options with you.  You may 
choose not to participate in the study and still receive treatment with intralesional 
triamcinolone acetonide. 
 
What are the costs? 
 
You will not be charged for procedures or clinic visits related to this research.  
Triamcinolone acetonide and Restylane will be provided free of charge while you are 
in the study.   
 
What will happen if there is a research-related injury? 
 
In the event that this research activity results in an injury, treatment will be available, 
including first aid, emergency treatment and follow-up care as needed.  Care for such 
injuries will be billed in the ordinary manner to you or your insurance company.  If you 
think that you have suffered a research related injury, let the study physicians know 
right away. 
 
What about confidentiality? 
 
The records and photography of this study will be kept private.  In any publications or 
presentations, you will not be identified by name or other recognizable way on any 
records, results or publications relating to the study.  
 
Participation and results in this study may be recorded in your medical record. 
 
Your information may be transmitted and/or reviewed by University of Minnesota (UM), 
University of Minnesota Physicians (UMP) and University of Minnesota Medical Center 
(UMMC) personnel who monitor research and UM, UMP and Medical Center personnel 
who need access to the information to complete the clinical trial. 
 


Restylane and Triamcinolone acteonide Intralesional Injections 
IRB Code Number: 0907M69801  
 
Version Date: 05/30/2014 
IRB Approval Letter Date: 11/17/2014 
 
Page 4 of 5 
Your protected health information (PHI) created or received for the purposes of this 
study is protected under the federal regulation known as HIPAA.  You will be asked to 
review and sign a separate HIPAA authorization concerning the use of this information.  
 
To these extents, confidentiality is not absolute.  
 
What are your rights as a research subject? 
 
Your participation in this study is entirely voluntary and you have the right to choose not 
to participate.  Your decision whether or not to participate in this study, or to withdraw 
from the study, will not affect any subsequent treatment by your doctor or this clinic, in 
any way and will not involve any penalty or loss of benefits to which you are otherwise 
entitled. 
 
The study team can stop your participation in the study at any time without your consent 
for any reason.  You also have the right to withdraw from the study at any time, even 
after signing the consent form, without giving a reason.  
 
If you withdraw voluntarily from the study or are taken out of the study, you may be 
asked questions about your experience in the study.  You also may be asked to have 
laboratory tests and physical examinations, as the doctor considers necessary. 
 
The study doctors will notify you if there are new findings about triamcinolone acetonide 
or Restylane® that might affect your willingness to continue to be in the study, or that 
could affect your health either during or after the study. 
 
You may ask any questions you have now, or if you have questions later, you may 
contact them at 612-625-7420. 
If you have any questions or concerns regarding the study and would like to talk to 
someone other than the researcher(s), you are encouraged to contact the Fairview 
Research Helpline at telephone number 612-672-7692 or toll free at 866-508-6961. You 
may also contact this office in writing or in person at Fairview Research Administration, 
2433 Energy Park Drive, St. Paul, MN 55108.  
 
 
 
 
 
 
 
 
 
 
 
 
 


Restylane and Triamcinolone acteonide Intralesional Injections 
IRB Code Number: 0907M69801  
 
Version Date: 05/30/2014 
IRB Approval Letter Date: 11/17/2014 
 
Page 5 of 5 
 
 
 
 
 
You will be given a copy of this form to keep for your records. 
 
 
Statement of Consent 
 
I have read the above information.  I have asked questions and have received answers.  
I consent to participate in the study. 
 
 
__________ 
Subject's Name (Print) 
         
     
 _ 
__________  
Subject's Signature 
 
__________________________ 
Date of Signature 
  
 
 
 
 
___________________________________ 
Name of person conducting consent process (Print)   
 
___________________________________ 
Signature of person conducting consent 
 
_________________________ 
Date of Signature