Needle-free Delivery of Intralesional Triamcinolone for Pediatric Alopecia Areata: a Pilot Study of Patient Tolerability
Phase: PHASE4
Conditions: Alopecia Areata
Sponsor: University Hospitals Cleveland Medical Center

 
 
Needle-free delivery of intralesional triamcinolone for pediatric alopecia areata: a pilot study of patient 
tolerability 
 
NCT05278858 
 
01/25/2022 
 
 
 
 
 
 
 
 
 
 

Objectives  
 
Primary Objectives  
o Validate patient tolerability of needle-free delivery of intralesional triamcinolone using 
patient-reported outcome measures.  
 
Secondary Objectives  
o Validate efficacy of needle-free delivery of intralesional triamcinolone for pediatric 
alopecia areata.  
o Assess the impact of needle-free delivery of intralesional triamcinolone on quality of life 
for pediatric alopecia areata.  
Background  
Alopecia areata (AA) is a significant medical condition that causes emotional and psychosocial distress as 
well as reductions in quality of life, especially in the pediatric population [Aldhouse et al 2020; 
Mostaghimi 2021; Christensen et al 2017]. When limited and patchy, an estimated 80% of those 
affected will see spontaneous recovery; however, this disease is characterized by frequent remittances 
and relapses and may progress to more severe disease – alopecia totalis or alopecia universalis (Ito 
2012; Barton 2021). Currently, there are no Food and Drug Administration- (FDA) approved treatments 
for pediatric alopecia areata, and there is a paucity of well-designed, randomized-controlled clinical 
trials (Meah et al 2020; Barton et al. 2021). Current recommendations, however, support the use of 
intralesional triamcinolone acetonide (ILTA) in adults (Meah et al 2020, Yee et al 2019), and pediatric 
patients (Barton et al. 2021; Fernando et al. 2020; Wang et al. 2012).  
The use of ILTA in the pediatric population is often limited due to fear of injections and pain [Hordinsky 
2015]. A 2002 chart review by Tan et al. demonstrated >50% improvement in 65% of pediatric patients 
at 12 weeks with use of ILTA, but >10% of patients dropped out of the study due to pain (Tan et al 2002). 
Current methods for pain mitigation include small gauge needles, cold sprays, distraction, and topical 
anesthetics, each with their own limitations (Want et al. 2012). Controlling pain is important as it can 
result in several physiological, psychological, and emotional consequences such as hypoxemia, vasovagal 
reaction, tachycardia, life-long needle phobia, fear of other procedures, higher levels of pain during 
other procedures, and possible avoidance of the healthcare system as adults (Ballard et al 2018; Birnie 
et al 2018). Given limited treatment options for pediatric patients with AA, ameliorating the fear and 
pain associated with needle-based ILTA is preferable, and the Med-Jet injector may be a device that can 
do just that. If well-tolerated, well-designed, randomized clinical trials may be feasible in the pediatric 
population. 
The Med-Jet-MBX needle-free injector (Med-Jet) is a novel, needle-free drug-delivery system, which we 
believe may be a solution to the pain and fear associated with needles. It uses regulated compressed air 
as a power source to accelerate an injectable fluid through a 0.005” orifice (6x smaller than a 30G 
needle) to penetrate the skin and deliver medication to a specific anatomical region (MedJet) The drug-
delivery device is highly configurable allowing adjustable depth and volume parameters (MedJet). In 
addition, the high-performance design allows for triggering multiple injection sites rapidly which is 
practical when needing to treat large surface areas (MedJet). 
 

Inclusion and Exclusion Criteria 
 
 
Number of Research Participants  
This is a proof-of-concept pilot study. Collins et al. stated that the boundary between mild and moderate 
pain is a numerical rating scale (NRS) score of 3 (Collins 1997). Previous use of needle-free delivery 
methods have demonstrated an NRS < 3 (Nantel-Batista 2017, Vadeboncoeur 2017). Based on previous 
studies and the pilot nature of this study, 15 subjects will be enrolled to determine whether mild or 
moderate pain would be anticipated in future large scale assessments. 

Recruitment Methods  
We will be recruiting patients from Northeast Ohio ages 6-17 years with patchy alopecia areata. Subjects 
will be recruited from the Pediatric Dermatology RBC Zagara Clinic by Dr. Sonal Shah, the Dermatology 
Clinical Trials Unit Database, and from dermatology provider referrals at University Hospitals practices 
on main campus, Beachwood, Twinsburg, Independence, Westlake, Cuyahoga Falls, and Concord. 
Patients identified from the clinical trials database will be approached by a letter of recruitment. We will 
also perform a Trinetx search of the EMR database to identify potential patients; we will contact the 
providers for these patients for permission to contact the patients and their parents. If identified by 
provider referral, the referring provider will inform the patient that a member of our clinical trials 
research group will contact them. A follow-up phone call will be done under the guidelines outlined in 
the interview guide. In addition, flyers will be placed in clinical areas and patients and their parents may 
inquire about joining the study by calling the phone number on the advertisement flyer in our 
dermatology outpatient clinics. The purpose of the phone interview questions is to pre-screen 
participants prior to commitment of a screening visit. Clinical trials staff may also pre-screen the EMR 
during the phone interview to aid with interview guide questions. After the initial prescreening phone 
call, patients will be asked to come to the clinic to begin the screening visit. 
Setting  
The research team recruitment efforts and all research procedures will be performed in the 
dermatology outpatient clinic at UH RBC Zagara Clinic, University Hospitals Cleveland Medical Center, 
Bolwell 3100 outpatient dermatology clinic, at the Department of Dermatology Skin Study Center, or at 
University Hospitals Dermatology, 2820 West Market Street, Suite 210, Fairlawn, OH 44333. 
Consent Process  
Subjects will be consented during the screening visit in a private patient room located at UH RBC Zagara 
Clinic. University Hospitals Cleveland Medical Center, Bolwell 3100, outpatient dermatology clinic, at the 
Department of Dermatology Skin Study Center, or at University Hospitals Dermatology, 2820 West 
Market Street, Suite 210, Fairlawn, OH 44333. Subjects will initially review the consent document with 
the study coordinator/study physician. After this initial review, the subjects, will be given the 
opportunity to review independently, discuss the study with family/friends/etc., and then ask the study 
team their questions or concerns prior to signing the consent. Subjects can take as much time as they 
need before deciding to participate or not to participate in the study. To ensure participant 
understanding of the study, the participant will be asked to explain the study back to the coordinator 
consenting the subject. To minimize coercion, participants will be given time to review the consent 
alone before deciding. The study coordinator will explain to the participant that their decision to 
participate/not participate will not impact their standard/routine clinical care. 
Study Design  
This is an interventional pilot study assessing the tolerability of needle-free delivery administration of 
ILTA with the Med-Jet as an alternative to conventional syringe and needle in patients with patchy 
pediatric alopecia areata. There will be a total of four (4) or five (5) visits necessary for study 
participation. We hypothesize that the Med-Jet will have acceptable pain tolerability, efficacy, safety, 
and a positive impact on patient quality of life. 

Study Procedures  
 
Informed Consent  
o An Informed Consent Form (ICF) will be signed by at least one parent or guardian before 
any study-related assessments are performed. Assent will be elicited when applicable 
prior to any study-related assessments being performed.  
 
Study Visits  
There will be four (4) or five (5) visits necessary for study participation:  
o If all inclusion criteria are met and no exclusion criteria are met on the same day and the 
patient and their guardian wish to start the study, the baseline visit and screening visit 
can be completed on the same day. This will decrease the number of visits from 5 to 4. o  
o If the patient has complete hair growth prior to the end of the study, they will complete 
all remaining visits, but they will not receive injections.  
o Visit 1 Screening (within 5 weeks prior to baseline visit or same day, estimated time 1 
hour if baseline activities are not performed):  
 
We will obtain informed consent, review inclusion/exclusion criteria, obtain 
medical history (medical conditions, surgeries, alopecia areata history, 
medications, allergies, social history, and relevant family history), obtain vitals, 
perform a complete skin exam, efficacy assessments, patientreported pain 
assessments, and quality of life assessments. A urine pregnancy test will be 
performed for persons of childbearing potential. 
o Visit 2 Baseline (Week 0, estimated time 1.5 hours if not performed the same day as 
screening):  
 
This will be the in-office intervention visit to be scheduled within 4-6 weeks of 
screening visit. We will review inclusion/exclusion criteria, obtain concomitant 
medications, adverse events (AE), obtain vitals, perform limited skin 
examination with efficacy assessment, photograph of target lesions, perform 
intervention injections per protocol, collect patientreported pain assessments 
and quality of life assessments. A urine pregnancy test will be performed for 
persons of childbearing potential. 
o Visits 3-5 Follow up study period (Week 4, 8, and 12, estimated time 30 minutes each):  
 
A limited skin exam, photographs, review of AEs and concomitant medications, 
efficacy assessments, QoL assessments and pain assessments will be performed. 
ILTA will be administered at each visit unless complete regrowth has occurred. A 
urine pregnancy test will be performed for persons of childbearing potential. 
Inclusion/Exclusion Criteria  
Subjects must meet all inclusion criteria and must not meet any exclusion criteria to qualify for 
participation in the study. The subject’s source documents must support his/her qualifications for the 
study. 
 
 
 

Past Medical History and Surgical History  
All medical, surgical, and social history, as defined in the electronic Case Report Form (eCRF) Completion 
Guidelines and the Study Manual, will be recorded. The date of medical diagnoses and surgical 
procedures will be recorded. 
Prior and Concomitant Medications and Therapies  
All medications and therapies being taken/used by the subject at the time of consent or at any time 
during the study will be recorded. All medications and therapies for alopecia areata, will be recorded. 
The stop dates and reason for stopping all medications and therapies prohibited in the study will be 
recorded. 
 
Intervention 
o At least two patches; each measuring 2 cm2 and at least 1 cm from one another will be 
identified, mapped out, and photographed.  
o Only one of the alopecic patches will be treated.  
o The concentration of ILTA will be controlled at up to 1 mg per cubic centimeter (0.1 ml 
@ a maximum concentration of 10mg/ml) injected every 1 cm until patch has been fully 
treated. The researcher providing treatment will be properly trained to deliver 
intradermal injections using the syringe and needle-free system. 
o Med-Jet with Triamcinolone (TAC) Procedure - ILTA will be administered into the 
patches. The PI and co-investigators will be performing interventions and follow proper 
training by the manufacturer on operation and handling of the device. Training will 
consist of a live course with a designated manufacturer technician supplemented with 
training videos. A standard sterile disposable 5 ml syringe will be used to draw TAC using 
standard sterile protocol. This syringe will be attached to the Med-Jet along with a 
sterile barrel and disposable sterile tip. The target lesion will be wiped with alcohol and 
injected with up to 10mg/ml of TAC directed towards the dermis to create a blanching 
wheal that is 1 cubic centimeter (total of 0.1 ml of injected fluid). The optimal injection 
pressure used on the subject will start at 130 pounds per square inch (psi) and increased 
by 5 psi until a blanching wheal is observed. The optimal pressure will be recorded. The 
injections will be repeated multiple times at the optimal pressure until the targeted 
patch is completely treated. 
o Patients will be treated at each visit unless complete regrowth has occurred. 
Photographs will be taken at each visit and activities will be completed as above. 
Safety Assessments  
 
Full Skin Exam/Limited Skin Exams/ Photographs A full skin examination includes evaluation of 
all cutaneous and mucosal surfaces. A limited skin exam includes only evaluation of the scalp. 
Photographs of affected skin will be completed each visit. Patient can decline examination of 
breasts, buttocks, and genitals during the full skin exam.  
 
Pregnancy Surveillance & Contraception Education Subjects of childbearing potential will 
require a urine pregnancy test at each visit.  
 
Monitoring Adverse Events Details of adverse event reporting may be found in section 6. 

Clinical Assessments  
 
Physician Efficacy Assessments  
o Severity of Alopecia Tool (SALT) Score The SALT score is a visual tool to help assess 
percentage of hair loss on the scalp. The scalp is divided into four sections – top, 
back, right side, and left side. Each section contributes to a total of 100% (i.e. top = 
40%, back = 24%, sides = 18% each). Raters assess total percentage of hair loss in 
the section and then multiple is by the respective multiplier which is based on that 
sections total percentage of the scalp – 40%, 24%, or 18%. Only terminal hairs are 
considered hair growth in this tool. (Olsen et al. 2004) Figure 1 illustrates the visual 
aid and allows for intuitive use. This is a static tool and only quantifies the hair loss 
at one point in time.  
o Alopecia Areata - Investigator Global Assessment (AA-IGA) The AA-IGA categorizes 
the scalp hair loss into 5 categories based on the SALT score. The five categories are: 
1 = None, 2 = Limited, 3 = Moderate, 4 = Severe, and 5 =Very Severe. The 
corresponding SALT scores for each category are: 1 = 0%, 2 = 1-20%, 3 = 21-49%, 4 = 
50- 94%, and 5 = > 95%. This is a static tool and only quantifies the hair loss at one 
point in time (Olsen 2004). 
o “Rule of Thumb” Assessment and Regrowth Categorization A patient’s thumbprint 
projection is approximately 1% of the scalp surface area (King 2019). When selecting 
the alopecic patch for treatment and its comparator, thumb projections will be used 
to quantify the percentage of total scalp hair loss contributed by each these patches 
at baseline. At each subsequent visit, the thumbprint projection from baseline will 
be used to determine percent of regrowth since baseline. Based on regrowth, the 
patient will be categorized into one of 6 categories: A0-5. Where A0 = no change or 
further loss, A1 = 1-24% regrowth, A2 = 25-49% regrowth, A3 = 50-74% regrowth, 
A4 = 75-99% regrowth, and A5 = 100% regrowth. 
 
Patient-Reported Efficacy Assessments  
o Patient-Reported Hair Loss – Whole Scalp This assessment will apply to the 
subject’s whole scalp surface area. This question will be asked at every visit. And it 
will include 5 numerical categories: 0 = No missing hair (0% of my scalp is missing 
hair; I have a full head of hair); 1 = limited area (1% to 20% of my scalp is missing 
hair); 2 = moderate area (21% to 49% of my scalp is missing hair); 3 = large area 
(50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my 
scalp is missing hair).  
o 5-Point Patient-Reported Regrowth – Whole Scalp and Selected Patches At each 
visit after the baseline visit, the subject will be asked about their perceived amount 
of hair regrowth both for the whole scalp and those patches selected at baseline. 
The subject will be able to select one of 5 categories: 1 = Further Loss, 2 = No 
Change, 3 = A Little Improved (<50% regrowth), 4= A lot of improvement (50-99% 
regrowth), and 5= Complete Regrowth (100%). 
 
Pain Score Assessment  
o Subjects will rate their pain using the Wong-baker FACES scale (Garra 2010) and a 
numerical rating scale (NRS) before and after the procedure. The NRS score ranges 
from 0-10 where 0 is no pain and 10 is the worst pain imaginable (Williamson 2005). 

 
Quality of Life Assessment  
o Subjects 6-11 years of age will use the Children’s Dermatology Quality of Life Index 
(cCDLQI) at each visit (Lewis-Jones 1995). Subjects 12-17 years of age will use the 
Teenager’s Quality of Life Index (T-QoL) at each visit (Basra 2018). Assessments 
should be performed prior to ILTA administration when applicable. 
 
Patient Survey  
o Participants will be given a survey at each visit. This will assess perceived 
tolerability, comfortability, associated fear, and assess experience and preference 
over conventional needle and syringe.  
Study Timeline  
The following chart lists the standard of care for treatment of patchy pediatric alopecia with ILTA. Each 
visit can be completed within + 7 days of the target date. Screening and baseline visits can be completed 
on the same day if appropriate. 
 
 
 
 
 

Data to be Collected 
 
Personal information (name, address, contact information, social security number)  
 
Medical records  
 
Personal medical history including medications and allergies  
 
Vital signs and physical exam findings  
 
Photographs  
 
Pregnancy laboratory test results if person of child-bearing potential  
 
Safety Data (Reported AEs)  
 
Efficacy Data (tPGA, pruritus score)  
 
Tolerability Data (Pain Score)  
 
Quality of life Data (DLQI, Patient survey) 
 
Data Analysis Plan  
Statistical analyses will be completed under the supervision of a statistician. Statistical analysis will be 
done by statistical software (e.g. SPSS, SAS, R, Excel; etc.) AUROC will be calculated in order to assess for 
accuracy. The χ2 test may be used for comparison of dichotomous variables, and the Mann-Whitney test 
may be used for non-normally distributed continuous variables. The cutoff value for significance was set 
at p = 0.05. 
Risks to Research Participants  
 
Intralesional Injections  
o Injections with the Med-Jet – Discomfort, bruising, injection site reaction (redness, 
swelling, pain), and infection  
 
Skin evaluations  
o Minimal emotional discomfort and embarrassment can be considered a risk  
 
Questionnaires  
o Minimal emotional discomfort can be considered a risk  
 
Breach of Confidentiality  
o Study participant information collected in the research process may include; contact 
information, consent documentation, demographics, social security number (necessary 
for reimbursement), and personal medical history. All data will be stored on the secure 
UH or REDCap© server, or as paper records stored in a locked cabinet. Data collected in 
this study will include: Patient records collected electronically and on paper, consent 
forms, and urine samples. While we maximize our ability to secure private information, 
participants could potentially be at risk for anticipated problems such as:  
 
Lost or stolen laptops/cabinets storing participant information  
 
Faxes sent to the wrong fax machine outside of the Health Sciences Center  
 
Paper without PHI not disposed of properly - i.e. shredded  
 
Information delivered to the wrong participant using the postal service, courier, 
or other delivery method 
Provisions to Protect the Privacy Interests of Research Participants  

The formal consent process and study visits will take place in a private exam room at our outpatient 
dermatology clinic. Each participant will have the study explained in its entirety with special attention to 
the length of the study, the actual study procedures, financial obligations, risks, benefits and alternatives 
to participation. Participants will be given ample time to consider study participation and encouraged to 
discuss with significant others, have any questions answered by the study staff. Only participants willing 
to undergo all study procedures will be asked to affirm participation by signing the consent form. Only 
study staff that have been trained on the study and having IRB required Human Subject Protection 
Training and authorized by the investigator will obtain consent. Subjects will be reminded the 
importance of adhering to all study requirements and their right to withdrawal at any time without 
affecting the quality of their individual medical care. Each class of data will be handled in the following 
manner: 
 
Patient Records, Consent Forms, and Study Data:  
o Patients enrolled into the study will complete informed consent and provide medical 
history. All patients upon entering the study will be assigned a unique identifier by 
REDCap© that will be used throughout the study to de-identify their information. 
Consent forms and paper records will be filed in study binders, stored in a locked room 
within the Department of Dermatology. Only authorized research personnel will have 
access to these records.  
o Patient records will be created and stored electronically on both the secure and 
encrypted University Hospitals server and the secure REDCap© server. REDCap© has 
been adopted and adapted specifically for our use on the CTSC under licensing terms 
with Vanderbilt University and has been approved for Vanderbilt, in collaboration with a 
consortium of leading research institutional partners who were funded by both 
Vanderbilt and the NCRR, has developed a software toolset and workflow methodology 
for electronic collection and management of research and clinical trial data. REDCap© 
data collection projects rely on a thorough study-specific data dictionary defined in an 
iterative self-documenting process by all members of the research team with planning 
assistance from the CTSC Informatics Core resources. The iterative development and 
testing process results in a well-planned data collection strategy for individual studies. 
Whether a study is submitted for scientific review on one of the three CTSC Clinical 
Research Units, each with a full-time dedicated informatics resource available to 
support investigators with REDCap©, or an institutional request outside of the 
controlled environment of the CWRU, our CTSC has made the REDCap© tool and 
associated resources available for use. 
o The REDCap© survey, a powerful tool for building and managing online surveys as the 
research team can create and design surveys in a web browser and engage potential 
respondents using a variety of notification methods. Both REDCap and REDCap Survey 
systems provide secure, web-based applications that are flexible enough to be used for 
a variety of types of research, provide an intuitive interface for users to enter data and 
have real time validation rules (with automated data type and range checks) at the time 
of entry. These systems offer easy data manipulation with audit trails and reporting for 
reporting, monitoring and querying patient records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R), and are managed in-

house by dedicated resources, including for backup/recovery to prevent data loss due to 
equipment failure. 
o The PI will ensure protocol adherence, proper protocol conduct, data quality, and 
subject safety and efficacy by conducting regular meetings with the entire study staff. 
The adverse events submitted by subject phone inquiry or email will be reviewed and 
adjudicated with all research team members. In addition, any adverse events or 
deviations to the protocol or other issues will be discussed at the Regulatory Meeting 
held monthly in the department of Dermatology. 
 
Tissue Samples: No tissue samples will be taken in this study. 
 
Photographs: All photographs will be de-identified and stored on the secure UH server, only 
accessible to authorized study personnel. In the event a photograph is taken of the face or any 
other identifiable feature, the patient’s identity may become known.  
 
Data Transfer/Transmission: Research data will be sent to a statistician for data management 
after finishing this research study: however, all the data will be stripped of patient identifiers 
prior to transfer. In order to comply with federal regulations, records identifying participants in 
this study may be reviewed by authorized study personnel, authorized representatives of the 
Institutional Review Board, or other federal regulatory officials responsible for oversight of 
human subject protection. Any data linking participants to their sample will be deidentified. A 
code will be used to link participants to identifying information and only the investigators and 
the research study coordinators will have access to this information, which will be stored on a 
server at University Hospitals Case Medical Center with a separate encryption code. Upon 
enrollment, each patient record will be stripped of all identifying information and assigned a 
unique numerical identifier that has no reference to any identifiable patient information. 
Potential Benefit to Research Participants  
In this study no benefits to the study subjects for participating in this research can be guaranteed, 
though some patients may experience improvement of their treated alopecic patches. Information 
gained from this study may improve therapies for patchy pediatric alopecia areata by demonstrating 
that needle-free drug delivery systems can be used safely and effectively.  
Withdrawal of Research Participants  
The participants are entitled to withdraw from the study at any time and for whatever reason 
without this influencing their access to the treatment via the investigator. We do not anticipate any 
circumstances that will require participants to be withdrawn from the research by the study 
investigator without their consent.  
Alternatives to Participation  
The only alternative for potential subjects is to not participate.  
Costs to Research Participants  
Study drug and all study procedures required by the study will be funded by the department of 
dermatology under the supervision of the principal investigator. Costs for medical treatment as a 
result of research-related injury will not be funded. Parking for all study-related visits will be 
validated.  

Research Participant Compensation  
The participant will be compensated a parking voucher for completion of each study visit. 
Provisions to Monitor the Data to Ensure the Safety of Research Participants 
Procedures for analysis and interpretation of data: The PI has meetings with the staff performing 
both the clinical and laboratory based assessments. These meetings occur on a minimum of a 
monthly basis, but often occur more frequently. These meetings are held for two primary functions: 
The meetings are, first, to discuss primary data and progress of the study. Data include both clinical 
observation and laboratory measurements. The secondary function of these meetings is to monitor 
clinical outcomes for potential adverse events associated with the study. The PI has put into place 
an action plan should adverse events occur during the course of the study. Adverse events that 
could be envisioned are outlined below:  
A. Responsible party for safety monitoring: In addition to the PI, safety monitoring will also be 
performed by the University Hospitals Data Safety and Monitoring Committee.  
B. Safety Monitoring Methods and Intervals: Grading method and attribution for adverse 
event reporting AE will be graded according to the following 0-5 scale: 
 
The PI will determine the relationship of AE’s to the test procedure/agent/device as; not related, 
possibly related, or definitely related, using standard criteria for clinical trials.  
 
All reported AEs will be followed until the event resolves or stabilizes OR  
 
The event returns to baseline OR  
 
The event can be attributed to agents other than the study agent(s) OR  
 
The subject withdraws informed consent OR  
 
The subject is lost to follow up. 
Implementation of the data and safety monitoring plan: The study team will internally review AEs at 
each patient visit and weekly with the PI. The study team will notify the DSMC of any Grade 3+ events 
within 1 week, and that the DSMC will formally review the study every 6 months. Adverse event reports 
for this protocol will be submitted to the approved IRB. Adverse Event Report Form sent in a timely 
manner consistent with the approved IRB policy.  
In addition, any serious adverse event (grade 3 or greater), except for those reported in the protocol, 
must be reported to the sponsor by the investigator by telephone, fax or email within 24 hours. A 

notification form will then be sent to the sponsor by fax or email with acknowledgement of receipt 
within 48 hours of the event. 
The investigator will also inform the sponsor of adverse events and abnormal results of the analysis, 
which are defined as decisive for the evaluation of safety of persons taking part in biomedical research. 
Drugs or Devices  
 
Triamcinolone acetonide injection therapy  
o Triamcinolone acetonide is not being trialed in this study. It is only included here for 
informational purposes given its significant role in our study.  
o Mechanism of Action: Triamcinolone is an organic lipophilic compound under the class 
of glucocorticoids which has a vast role in treatment of inflammatory skin conditions. It 
is proposed that TAC binds to glucocorticoid receptors in the cytoplasm and undergoes 
conformational changes. This drug-protein complex directly binds to DNA affecting gene 
regulation and transcription of various specific messenger ribonucleic acid (mRNA). In 
the skin, this leads to reduction of proinflammatory cytokines, t-cell lymphocytes, and 
suppression of keratinocyte growth factors. This is particularly helpful in psoriasis as 
cytokine/t-cell dysregulation and keratinocyte hyperproliferation is the pathogenic 
hallmark. In the dermis, glucocorticoids suppress fibroblasts activity and collagen/elastic 
fiber production which can lead to dermal volume reduction and subsequent dermal 
atrophy seen clinically.13  
o Dosing, Formulation, Frequency: Multiple formulations of triamcinolone acetonide exist 
including lotions, topical spray, nasal spray, cream, ointment, dental paste, and 
injectable suspension. The injectable suspensions are produced in two concentrations, 
10mg/ml or 40mg/ml. In our study we will be performing injections using the 10mg/ml 
injectable suspension to inject up to 1 mg of TAC per cubic centimeter to minimize drug-
related adverse events. The TAC may be diluted with sterile saline to a concentration 
less than 10 mg/ml. After one intervention of TAC, the first signs of involution start 4-14 
days after injection with max involution at 2-3 months, followed by relapse at 6-12 
months at which a repeat intervention may be considered.14 
 
Med-Jet Injector  
o The Med-Jet injector is a needle-free injection system which consists of a handheld 
firing body/trigger, sterilized barrel, disposable luer lock syringe, disposable nozzle cap, 
and disposable splash guard. The Med-Jet injector is designed to deliver drugs or 
biologics into the intradermal, subcutaneous or intramuscular tissues, by means of a 
narrow, high-velocity jet of fluid, which penetrates the surface of the skin and delivers 
the fluid to the target tissue. Upon attenuation of the trigger, the device uses regulated 
compressed carbon dioxide (CO2) or compressed air as a power source to accelerate an 
injectable fluid through a small orifice (0.005”) in a fraction of a second. The dose 
volume can be pre-set with an adjustment knob at an accuracy of ±0.0125ml for 0.25ml 
injections. The depth of injection is also adjustable based on pressure as denoted by 
pounds per square inch (psi) which in our study will be targeting the dermis at an 
average 140 psi which is needed to create a wheal (Nantel-Battista 2013). Upon release, 
the dose chamber is automatically refilled and ready for the next actuation for multiple 
injections. 

o The needle-free drug delivery system with triamcinolone could be more efficacious then 
using a conventional syringe due to the dispersion physics of forcefully propelling a fluid 
into the skin [Schramm-Baxter 2004; Park 2015). Jet propulsion results in a sporadic-
shaped distribution of fluid under the skin when compared to a bolus-shape using 
conventional syringes. The dispersion of fluid made by jet propulsion could be valuable 
delivering triamcinolone to the dermis in patchy pediatric alopecia areata (Meah et al 
2020). 
o Administering ILTA using the needle-free drug delivery system will have a similar safety 
profile to conventional syringes with some additional benefits. One benefit of a needle-
free system is the zero-risk of needle-stick injuries on providers. Lipoatrophy, a rare side 
effect of ILTA when injected too deep and in proximity to the subcutaneous fat, could be 
minimal with needle-free injections due to the operator-controlled injection depth 
parameter. Reported complications of needle-free injections were seen with devices 
using high driving pressures (1,420 psi); however, in this study, we will be using a low-
pressure system (< 160 psi) (Seok 2016; Barolet 2018; Haneke 2012) This method of ILTA 
delivery has been used in the hyperhidrosis or nail psoriasis trials and none of the 
subjects encountered significant adverse effects with a low-pressure system 
(Vadeboncoeur 2017, Nantel-Battista 2014). This device is not currently approved for 
use in the United states by the FDA. We are requesting a determination from the IRB for 
investigational use of the Medjet as a nonsignificant risk medical device. 
o The Medjet needle-less system propels an injectable fluid through a 0.005” orifice which 
is 6x smaller than a 30G needle (MedJet)> The small orifice combined with a quick 
delivery low-pressure system results in decreased pain scores for patients. In the nail 
psoriasis trial, 17 patients were injected over the proximal nail fold, which is a rather 
sensitive area, and reported a mean pain score of 2.1 based on a 10-point scale (Nantel-
Battista 2017). Similar results were seen in the hyperhidrosis trial with scoring an 
average 3 on a 10-point scale over the palms (Vadeboncoeur 2017). Finally, the absence 
of a needle will create a more tolerable environment for patients who are needle 
phobic. 
 
 
 
 
 
 
 
 
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