Clinical trial NCT03991936
Conditions: Nail Psoriasis Nail Diseases
Keywords: Nail Psoriasis Nail Diseases Triamcinolone acetonide Triamcinolone
Sponsor: Weill Medical College of Cornell University
Start date: 2020-03-11; Completion date: 2023-03-29
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to determine the lowest effective concentration of intralesional triamcinolone acetonide in the treatment of nail psoriasis.

Detailed description:

Arms: arm 1: Participants receive an intralesional injection of 0.1-0.2 mL of normal saline in one psoriatic fingernail once per 6 weeks until 24 weeks. arm 2: Participants receive an intralesional injection of 0.1-0.2 mL of 2.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. arm 3: Participants receive an intralesional injection of 0.1-0.2 mL of 5.0 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. arm 4: Participants receive an intralesional injection of 0.1-0.2 mL of 7.5 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks. arm 5: Participants receive an intralesional injection of 0.1-0.2 mL of 10 mg/mL intralesional triamcinolone acetonide in one psoriatic fingernail once per 6 weeks until 24 weeks.
Interventions: intervention 1: Placebos intervention 2: Triamcinolone Acetonide 2.5 mg/mL intervention 3: Triamcinolone Acetonide 5.0 mg/mL intervention 4: Triamcinolone Acetonide 7.5 mg/mL intervention 5: Triamcinolone Acetonide 10 mg/mL
Intervention descriptions: intervention 1: Normal saline intralesional injection intervention 2: 2.5 mg/mL intralesional injection intervention 3: 5.0 mg/mL intralesional injection intervention 4: 7.5 mg/mL intralesional injection intervention 5: 10 mg/mL intralesional injection

Protocol documents:
Prot_SAP_000.pdf: 
1 
Benefit of different concentrations of intralesional triamcinolone 
acetonide in the treatment of nail psoriasis 
Protocol Version Date: 17 October 2018 
Principal Investigator: Shari Lipner, MD, PhD 
Administrative Contact:  
Jose Ricardo 
jwr4001@med.cornell.edu


2 
 
INVESTIGATOR RESPONSIBILITY/SIGNATURE PAGE 
 
Prior to participating in this clinical trial, the Principal Investigator must obtain written 
approval from his/her Institutional Review Board (IRB).   
 
The Principal Investigator must also agree to: 
 
● Conduct the trial in accordance with the protocol, the signed Clinical Study 
Agreement, the International Conference of Harmonization Good Clinical Practice 
(GCP) guidelines, and all applicable FDA clinical trial/device trial regulations.  
● Participate in all sponsor-required training prior to study initiation. 
● Not begin the study until IRB approval is secured. 
● Obtain informed consent as well as authorization for utilization of study data 
including photographic images from each prospective subject prior to enrollment, 
using IRB-approved forms. 
● Provide all required data and permit source document verification of study data 
with subjects’ medical records. 
● Permit representatives of FDA to review, inspect and copy any documents 
pertaining to this clinical study. 
● Retain all case report forms (CRF) and study documentation for the required 
number of years after study completion in accordance with the appropriate 
legislation. 
 
The Principal Investigator may delegate one or more of the above functions to another 
qualified member of the site study team. However, the Principal Investigator retains 
overall responsibility for proper conduct of the study, including obtaining and documenting 
subject informed consent, compliance with the study protocol, and the collection of all 
required data. 
 
 
I have read and understand the contents of the protocol. I agree to meet all the 
expectations outlined above. 
 
 
 
 
 
 
 
 
 
Investigator Name (print) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Signature  
 
 
Date 
 
 
 
 
 


3 
 
 
TABLE OF CONTENTS 
 
 
1.   INTRODUCTION/BACKGROUND 
4 
2.   SIGNIFICANCE 
8 
3.   OBJECTIVES 
8 
4.   SUBJECT POPULATION 
9 
5.   CONCOMITANT MEDICATIONS 
10 
6.   RESEARCH DESIGN / METHODS 
10 
7.   ADVERSE EVENTS AND SIDE EFFECTS 
15 
8.   EFFICACY EVALUATIONS 
17 
9.   INSTITUTIONAL REVIEW BOARD 
17 
10. DATA ANALYSIS 
17 
11. MONITORING AND QUALITY ASSURANCE 
18 
12. PRIVACY AND CONFIDENTIALITY  
 
 
 
 
 
     19  
13. EARLY TERMINATION 
 19 
 
REFERENCES 
APPENDIX A – NAIL PSORIASIS SEVERITY INDEX 
APPENDIX B – NPQ10 
 
 
 
 
 
 
 
 


4 
 
INTRODUCTION/BACKGROUND 
 
Psoriasis is a chronic, inflammatory disease that affects the skin, joints and nails. The 
condition affects as many as 7 million people in the United States, approximately 50% 
of whom are estimated to have nail involvement.[1, 2] The effects of psoriasis on the 
nail are often overlooked in light of cutaneous manifestations. However, the lifetime 
incidence of nail involvement is 80-90% among patients with cutaneous psoriasis.[2] In 
some cases, nail psoriasis is the only manifestation of the disease.[3] Nail psoriasis can 
also be a marker of psoriatic arthritis, which coexists in 80% of cases and can have 
debilitating consequences.[2] 
 
Nail psoriasis results in pitting of the nail, separation of the nail from the nail bed, 
thickening of the skin under the nail, nail discoloration and other abnormalities.[2] Left 
untreated, nail psoriasis progresses and can result in social stigma, pain, and loss of 
manual dexterity, which may affect typing, computer work, and many other activities 
requiring the use of hands. The disorder is diagnosed clinically through physical 
examination of the nails. A supporting history of cutaneous psoriasis is helpful, though 
not necessary, in making the diagnosis. Tissue sampling and histological examination 
can also support the diagnosis, and x-rays of the hand may be used to check for the 
presence of psoriatic arthritis, which commonly coexists with nail psoriasis.[2, 4]  
 
Current treatments for nail psoriasis include topical therapies, systemic medications, 
intralesionals, and biologics. The treatment of nail psoriasis is challenging because few 
guidelines exist; treatment regimens are clinician-dependent and are tailored to the 
patient’s needs.[5] Topical therapy is typically used for mild cases of nail psoriasis. 
Topical steroids are commonly used as “first-line” therapy. The advantages of topical 
steroids include low cost and low rate of adverse effects (when not used for prolonged 
periods).[5] Other topical therapies such as vitamin D analogs, retinoids, fluorouracil, 
anthralin and tacrolimus are also used. Though many of the therapies listed above are 
effective in the treatment of nail psoriasis, as topical medications they have several 
important limitations.[5] The major limitation of all topical medicines is reliance on 


5 
 
patient compliance. The medications must be applied up to two times a day for as long 
as 2-12 months. Another limitation is limited penetration into the affected part of the nail 
unit. The therapies are not effective on all nail changes associated with nail psoriasis, 
and may have poor absorption into the parts of the nail unit responsible for different 
features of the disease. Systemic therapies such as acitretin, cyclosporin A, and 
methotrexate are also sometimes used. Good results have been reported with the use 
of systemics, though they also require strict patient compliance. Biologic drugs such as 
alefacept, etanercept, infliximab are newer therapies in the treatment of nail psoriasis. 
They too, have shown to be effective, though confer a risk of severe 
immunosuppression.  
 
Intralesional corticosteroids, most commonly triamcinolone acetonide (ITA), are often 
used in the treatment of nail psoriasis. TA is a corticosteroid that is FDA approved for 
the treatment of psoriasis via intralesional injection. Corticosteroids are used in the 
treatment of many inflammatory dermatologic diseases. Briefly, they work by inhibiting 
the body’s inflammatory response. At higher doses, the response is more inhibited.  
 
ITA is used in concentrations ranging from 2.5mg/mL - 10mg/mL in the treatment of nail 
psoriasis.[1, 3] There is debate in the literature regarding the ideal concentration of ITA 
to treat nail psoriasis.[1] That is, the dose that gives the best efficacy while limiting side 
effects. No randomized prospective studies investigating this question exist. A number 
of authors have conducted studies on the efficacy of ITA in the treatment of nail 
psoriasis using specific concentrations of ITA (most commonly 5mg/mL or 10mg/mL). 
[6-10] To our knowledge, no authors have directly compared the concentrations to one 
another. Determining the lowest effective concentration of ITA is important because 
patients receiving higher than necessary concentrations may experience an increase in 
side effects. The side effects of corticosteroids such as TA are numerous, and include 
thinning of the skin at the site of injection, thinning along the lymphatic vessels draining 
the injection site, allergic reactions, infection, and pituitary suppression.[11] 
 


6 
 
Previous studies have demonstrated the efficacy of ITA, at different concentrations 
ranging from 0.1 to 10 mg/mL at 0.1-0.2mL volumes.[6-8, 12] In these studies, nail 
psoriasis has been shown to significantly clinically improve with the treatment. The 
studies cited occurred mostly before the year 2000. In no studies to our knowledge were 
the concentrations compared directly. In 2000, the Nail Psoriasis Severity Index (NaPSI) 
was developed. The NaPSI is a nail psoriasis assessment tool developed by one of the 
leaders in the field of nail pathologies, Dr. Richard Scher. This tool, detailed in Appendix 
A, allows researchers and clinicians to objectively quantify changes in psoriatic nails 
following treatments and study interventions.[13] Prior to 2000, authors used different 
methods to assess change following the study intervention, but most of these were 
qualitative. For example, Peachey et al. used a qualitative assessment (i.e. no 
improvement versus slight improvement versus marked improvement.) De Berker also 
used a qualitative assessment, but graded each feature of nail psoriasis (i.e. ridging, 
pitting, etc.) separately. The most recent study cited by Nantel-Battista et al., did use the 
NaPSI score. This score is increasingly widely used in studies of nail psoriasis. 
 
The frequency and length of time that injections were administered in the cited studies 
varied between studies, but in most occurred at monthly intervals for 4-6 months. Four 
to six months is approximately the amount of time needed for the nail to completely 
grow, and therefore the amount of time necessary to see results from the study 
intervention. 
 
Our approach is to investigate different concentrations of ITA in the treatment of nail 
psoriasis to determine which is the lowest effective concentration. All concentrations 
under investigation are part of standard clinical practice, as there is no consensus in the 
literature on the lowest effective concentration. Our study will consider only the 
fingernails, and not the toenails, of subjects with nail involvement for two reasons. First, 
toenail psoriasis is less common compared to fingernail psoriasis.[2] Second, in our 
clinical experience, patients are more motivated to treat fingernails, due to their 
important functions in daily activities, and for cosmetics. Thus, the treatment of 
fingernail psoriasis with ITA is most clinically relevant. 


7 
 
Our study will enroll participants with at least two fingernails involved. This will allow us 
to use placebo in one fingernail of every participant, thus establishing the efficacy of ITA 
in our study by allowing us to compare placebo to ITA. In addition to efficacy 
assessments, we will measure changes in quality of life due to the study intervention as 
an outcome. Quality of life assessments will be done with the NPQ10 assessment, which 
is a validated assessment tool developed to measure quality of life in nail psoriasis.[14] 
This tool is included in Appendix B. 
 
All fingernails not treated with placebo will undergo randomization to four groups 
corresponding to four concentrations of ITA under investigation (2.5, 5.0, 7.5, 10.0 
mg/mL). Thus, a participant with five affected fingernails may have a different 
concentration of ITA used as the study intervention in each fingernail. This approach 
has been used in studies of ITA in other dermatologic diseases such as alopecia areata. 
[15] In the cited study, the lesions of subjects with alopecia areata were divided into four 
quadrants, corresponding to four concentrations of ITA that were injected. We believe 
this approach will be helpful in comparing the efficacy of different concentrations in the 
same patient. 
 
SIGNIFICANCE 
Psoriasis is a chronic, inflammatory condition that affects millions of people in the United 
States. Approximately 50% of patients with cutaneous psoriasis have nail involvement; 
nail psoriasis causes significant pain, and can lead to loss of manual dexterity, therefore 
impairing the ability to use the hands or perform work. Intralesional triamcinolone 
acetonide is considered one of the mainstays of treatment for nail psoriasis. By 
determining the lowest effective concentration of this medication for nail psoriasis, we can 
minimize side effects for millions of people affected with nail psoriasis worldwide. 
 
OBJECTIVES 
 
The primary objective of this study is to determine the lowest effective concentration of 
intralesional triamcinolone acetonide in the treatment of nail psoriasis. 


8 
 
 
The secondary objective is to determine that intralesional triamcinolone acetonide is 
effective in the treatment of nail psoriasis when compared to placebo, using the Nail 
Psoriasis Severity Index as a measure of improvement. 
 
Another secondary objective is to determine the rate and nature of side effects 
experienced by patients using different concentrations of intralesional triamcinolone 
acetonide for the treatment of nail psoriasis. 
 
Another secondary objective is to assess baseline quality of life in patients with nail 
psoriasis and determine if there is a change in quality of life with the study intervention. 


9 
 
SUBJECT POPULATION 
 
Inclusion Criteria: 
The subject must meet ALL the criteria listed below for entry: 
1. Subject must be at least 18 years of age, of either sex or transgendered individuals, 
and of any race; 
2. Subject must have nail psoriasis that is clinically diagnosed of at least 2 fingernails. 
3. Subject must be willing to give written informed consent and able to adhere to 
procedures and visit schedules; 
4. Subject must consent to having the fingernails photographed during the study 
period 
 
Exclusion Criteria: 
The subject will be excluded from entry if ANY of the criteria listed below are met: 
 
1. 
Subject with any clinically significant condition or situation, other than the 
condition being studied that, in the opinion of the investigator, would interfere with 
study evaluations or optimal participation in the study. This is including, but not limited 
to: immunodeficiency, onychomycosis, any other nail condition other than psoriasis, 
allergy to triamcinolone acetonide, local anesthetic, normal saline, or any other 
material used for procedures. 
2. 
Subject 
who 
has 
received 
radiation 
therapy, 
chemotherapy, 
and/or 
immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 
month within the 6 months of study (exception: inhaled steroids); 
3. 
Subject known to have received treatment with investigational drugs or devices 
within 30 days prior to enrollment into this study; 
4. 
Subject who is unwilling to abstain from any cosmetic nail treatments outside 
those provided by the study clinic, beyond basic nail trimming (i.e. no spa nail 
treatments, no nail polish use, no other topical prescription nail medication); 


10 
 
5. Subject who is unwilling to abstain from any medical nail treatments on their nails 
other than the study intervention (i.e. topical steroids, antifungal creams) for the 
duration of the study intervention and for duration of the washout period (if applicable); 
6. 
Subject who is part of the staff personnel directly involved with this study or a 
family member of the investigational study staff 
 
CONCOMITANT MEDICATIONS 
 
All concomitant medication usage from the period of 60 days prior to the trial through the 
trial period shall be documented and include the following information:  
1. Medication 
2. Indication 
3. Dosage (including frequency) 
4. Start / Stop date 
All concomitant medication usage will be checked with respect to exclusion criteria and 
cross-referenced to adverse events (if any). 
 
RESEARCH DESIGN / METHODS 
 
Our approach is to assess the efficacy and safety of different concentrations of ITA in 
the treatment of nail psoriasis. A similar approach has been taken with psoriasis of the 
skin, and alopecia areata.[15, 16] 
 
Hypothesis: The lowest concentration of ITA tested offers the best ratio of efficacy to 
safety. 
 
Study Design: A total of 10 subjects who have nail psoriasis of at least two fingernails 
will be enrolled. During the screening visit, the investigator will discuss with each subject 
the nature of the study, its requirements and its restrictions during the Informed Consent 
Process. 
 


11 
 
The following will be performed at the screening visit: 
• 
Review of inclusion/exclusion criteria 
• 
Medical history and demographics including age, gender, history of psoriasis 
• 
Review of medications 
• 
Examination of the fingernails 
• 
Possible tissue sampling (clipping the nail) to rule out onychomycosis 
• 
X-ray of the affected hand 
• 
Administration of a survey assessing quality of life at baseline. 
• 
Use the study intervention (intralesional triamcinolone acetonide injections) 
on your fingernail(s) 
 
Eliciting the patient history and physical exam are part of standard clinical practice. 
Nail psoriasis is a clinical diagnosis. Tissue sampling may be taken if there is a question 
about diagnosis, or if there is a possible confounding diagnosis such as onychomycosis. 
X-rays of the hand may also be taken to determine if there is co-existing arthritic 
involvement, which is very common in nail psoriasis. Both of these events are part of 
standard clinical practice and are not research-related procedures. Patients who only 
decline to obtain x-rays won’t be excluded from the study. 
 
After completion of the informed consent process, the study site will take photos of the 
affected fingernails proposed for enrollment.  
 
Washout Period: Subjects who are using any form of treatment on their nails at the time 
of the screening visit may participate in the study provided that they are willing to 
undergo a two-month washout period. During this time, they must abstain from using 
any nail treatments (including, but not limited to: spa nail treatments, nail polish use, 
prescribed topical or systemic medications indicated for the nails, over the counter nail 
treatments, or any other nail intervention with the exception of routine clipping and 
washing.) After the washout period, the subject may be re-evaluated for participation in 
the study. 
 


12 
 
Enrollment and Randomization: Patients with at least two affected fingernails will be 
enrolled. For each participant, one fingernail will receive an intralesional injection of 0.1-
0.2 mL of normal saline (placebo). The other affected fingernail(s) will receive an 
injection of 0.1-0.2mL of a pre-determined concentration of ITA. Four concentrations of 
ITA will correspond to four study groups: 2.5mg/mL, 5mg/mL, 7.5mg/mL and 10mg/mL. 
Participants’ fingernails will be randomized such that there are approximately equal 
numbers of fingernails in each of the five groups (four study interventions, one placebo). 
To avoid bias, fingernails will be assigned to groups systematically. Fingernails will be 
assigned to groups in order of anatomical convention. For example, if the subject has 
involvement of both the thumb, forefinger and third finger of the right hand, the thumb is 
the first digit, so, if involved, it will be assigned first according to the table below. If a 
subject has involvement of fingernails of both the right and left hand, the fingernails of 
the right hand will be assigned before the left. The table assumes that up to 50 nails will 
be affected between the 10 subjects enrolled. In our clinical experience, this is a 
reasonable expectation. If more or fewer fingernails are involved during the enrollment 
period, the randomization table will be adjusted accordingly. The concentration of ITA 
injected will be different for each group. All other study procedures will be the same 
between groups.  
 
Fingernail 
Group 
1
5
2
3
3
4
4
1
5
2
6
4
7
5
8
1
9
3
10
2
11
3
12
4
13
5
14
1
15
2


13 
 
16
2
17
1
18
3
19
5
20
4
21
5
22
4
23
3
24
2
25
1
26
1
27
2
28
3
29
4
30
5
31
1
32
2
33
4
34
3
35
5
36
5
37
3
38
4
39
2
40
1
41
1
42
3
43
4
44
2
45
5
46
1
47
5
48
2
49
4
50
3
Table 1: Randomization of subjects’ fingernails to groups. Groups are numbered 1-5 
and correspond to concentrations of ITA such that 1=2.5mg/mL; 2=5.0mg/mL; 
3=7.5mg/mL; 4=10.0mg/mL; 5=placebo. 
 


14 
 
Procedures: Injections of ITA will be administered using standard methods. Hand 
hygiene procedures will be performed and the administrator will use gloves. 
Triamcinolone acetonide, at the determined dose, will be drawn into a solution of 1% 
lidocaine. The nail fold of the affected nail will be cleaned with an alcohol swab. In 
addition to the local anesthetic given as part of the injection, the area will be 
anesthetized with an ethyl chloride spray immediately prior to injection using a 30 gauge 
needle. During injection, the participant may experience light pressure. Following 
injection, the wound will be covered with a bandage. A board-certified dermatologist will 
perform all procedures and will be present to monitor for unlikely adverse events, such 
as excessive bleeding.  
 
None of these procedures differ from the current standard of care. The only aspect that 
will differ in the treatment of affected nails is the concentration of ITA used. However, 
there is no current standard of care regarding the concentration; all concentrations 
under investigation are part of typical clinical practice and have been validated in 
studies.[1] The purpose of this study is to determine the lowest effective concentration 
of ITA in the treatment of nail psoriasis. 
 
The schedule of treatments is as follows: 
Treatment will be performed using ITA with a frequency of once per 6 weeks +/- 1 week. 
A follow-up visit will be performed at 24 weeks, ending the study period. 
 
 
The following will be performed at the first visit: 
x Completion of Nail Psoriasis Severity Index  
x Collection of survey to document subject's quality of life 
x Use the study intervention (intralesional triamcinolone acetonide injections) on 
the subject’s fingernail(s) 
x Take pictures of subject’s nails before and possibly after treatment 
x Take an X-ray of the affected hand 
 
 


15 
 
The following procedures will be performed at every treatment visit after the first, and at 
the follow-up visit: 
● Measurements of clear nail growth (in millimeters), clear nail area (in mm2) 
● Completion of Nail Psoriasis Severity Index. 
● Use the study intervention (intralesional triamcinolone acetonide injections) on 
the subject’s fingernail(s) 
● Take pictures of subject’s nails before and possibly after treatment 
● Collection of adverse events, if there are any 
 
The following procedures will be performed at the follow-up visit only:  
● Measurements of clear nail growth (in millimeters), clear nail area (in mm2) 
● Completion of Nail Psoriasis Severity Index. 
● Take pictures of subject’s nails  
● Collection of survey to document subject's changes in quality of life since the 
beginning of the study intervention and subjective assessment of nail since the 
beginning of the study intervention 
 
ADVERSE EVENTS AND REPORTING 
 
Adverse event/effect (AE) assessment will be ongoing throughout the study. All adverse 
events shall be reported by the clinical Investigator to the Sponsor and IRB following 
WCMC’s reporting policies.  
 
Unanticipated Adverse Effect (UAE) 
An unanticipated adverse effect is an adverse effect on health and safety caused by, or 
associated with, the study intervention, if that problem was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application, or any 
other unanticipated  problem that relates to the rights, safety, or welfare of subjects. 
 


16 
 
The Investigator shall be responsible for determination of the causal relationship of all 
adverse events to the study intervention and/or procedure. The Principal Investigator is 
responsible for monitoring the safety of the subjects enrolled.  
 
Any adverse events will be reviewed and analyzed by the Principal Investigator as soon 
as the event occurs and will be documented in the subject’s binder. Any unexpected 
adverse reactions will be reported by telephone to the IRB within 48 hours of observing 
the event.  
 
No major adverse effects are anticipated during this study; however, we will screen for 
severe pain (Pain ≥ 8/10 on self-reported scale).  
 
The following minor adverse effects are anticipated: cold/burning sensation, minor to 
moderate pain (Pain ≤7 on VAS scale), minor swelling (edema), minor hematomas, and 
temporary erythema (redness). We will screen for additional possible but not expected 
adverse effects. If the minute treatment reaches an intolerable threshold of pain >7, the 
study intervention will be stopped and more anesthetic may be applied if appropriate. 
Such pain could result from local injection of the skin.  A physician will be on site for the 
to assess for adverse events as needed. 
 
POTENTIAL ADVERSE EFFECTS: 
 
 
 
Epidermal/Nail Response Assessed
Grading
 
 
Pain 
0 = none      1      2     3  = extreme 
 
 
Persistent Erythema 
0 = none      1      2     3  = extreme 
 
 
Skin atrophy 
0 = none      1      2     3  = extreme 
 
 
Bleeding 
0 = none      1      2     3  = extreme 
 
 
Burning/cold sensation 
0 = none      1      2     3  = extreme 
 
 
Hematoma 
0 = none      1      2     3  = extreme 
 
 


17 
 
Other (please describe and grade, or 
enter ‘0’ for none) 
 
 
 
Table 1. The physician shall evaluate the patient’s response to the treatment and screen for 
possible side effects as listed. 0 = none, 1 = mild, 2 = moderate and 3 = extreme. 
 
Photos shall be taken of any visible treatment effects. 
 
EFFICACY EVALUATIONS 
 
The primary endpoint of this study is to assess the lowest effective concentration of 
intralesional triamcinolone acetonide in the treatment of nail psoriasis. Safety and 
tolerability shall be determined based on the reported number of adverse events as 
outlined in the Adverse Events Section and subject-reported symptoms (if any).  
 
In order to evaluate the efficacy of the proposed treatment, high quality photographs will 
be taken before and after treatment using standardized lighting, exposure settings, and 
subject positioning. Trained individuals shall assess the changes in the photographs as 
outlined in the following paragraphs. 
 
Preliminary assessment of the efficacy of the study intervention will be determined by 
measuring the amount of clear nail growth. This growth will be compared to the initial 
amount of clear nail recorded at baseline. Changes in clear area and NaPSI will also be 
reviewed as study intervention progresses and compared to baseline values.  
 
INSTITUTIONAL REVIEW BOARD 
 
Prior to beginning this study, approval for all study related documents (protocol, consent 
form, advertising) will be obtained from the Weill Cornell Medical College IRB. 
 


18 
 
DATA ANALYSIS 
 
Efficacy will be evaluated using nail plate measurements to assess clear nail plate growth 
and rates of clinical improvement. Clinical improvement will be assessed using the NaPSI, 
an objective validated measuring tool developed by one of the leaders in the field of nail 
pathology for use in clinical trials on treatment of nail psoriasis.  
 
Adverse effect intensity will be assessed at each of the treatment visits using a 0-3 scale 
(0=none, 1=mild, 2=moderate, 3=severe) for each side effect with changes from baseline 
analyzed using the Wilcoxon signed-ranks test and presented as medians and ranges.  
 
Statistical analysis will be performed using SAS version 9.2 (SAS Institute, Cary, NC).  
Two-tailed P < 0.05 will be considered statistically significant.       
 
MONITORING AND QUALITY ASSURANCE 
 
Site Monitoring  
The Principal Investigator will evaluate compliance with the protocol, FDA regulations, 
IRB and the signed investigator agreement. The study will be monitored according to 
applicable provisions and applicable national law/regulations.   
 
The Principal Investigator will be reviewing data on an ongoing and consistent basis 
throughout the duration of the study. The Principal Investigator will review data weekly. 
The Principal Investigator is responsible for protecting the rights, safety, and welfare of 
subjects under his/her care. Principal Investigator will be responsible for this review and 
for determining whether the research should be altered or stopped. If any severe adverse 
effect directly related to the study intervention occurs, Principal Investigator will report to 
the IRB or others who might be assigned primary responsibility for this monitoring activity. 
 


19 
 
Monitoring will include a verification that informed consent was properly obtained for all 
enrolled study participants, a review of clinical records for accuracy and completeness, 
resolution of missing or inconsistent results and a review of source documents.  
 
Protocol Adherence 
The study investigators are responsible for performing the study in compliance with the 
protocol. All deviations to the protocol are to be documented in the study records. Any 
protocol violation that may result in significant additional risk to the subject or that may 
impact subject safety should be reported to the IRB within 5 working days if they occur.  
Protocol deviations that do not result in additional risk to the subject (e.g., subject missed 
visit), are not required to be reported to the IRB; however, they must be documented on 
the study case report forms and may be reported as part of the annual review process. 
 
Data Management and Collection 
Data will be recorded and retrieved via REDCap software. Missing or unclear data will be 
investigated by the investigators and will be retrieved and clarified by study personnel as 
necessary throughout the study.  
 
PRIVACY AND CONFIDENTIALITY 
 
All source data will be organized and filed into individual subject binders. Any pertinent 
notes to file regarding the subject and their study visit will be documented by the study 
coordinator and kept in the applicable subject binder. All subjects will be assigned a study 
identification number, which is the only item that will appear on the subject binder.  All 
data used in the analysis and reporting of this evaluation will be used in a manner without 
identifiable reference to the subject. 
 
Personnel associated with the Investigator’s office, the U.S. Food and Drug 
Administration (FDA), and the Institutional Review Board, have the right to review the 
data, including photographs, collected during this study. They are also required to 
maintain confidentiality.  


20 
 
 
EARLY TERMINATION 
 
If a subject decides to stop taking part in the study for any reason, the subject will be 
asked to make a final study visit. At this visit, same procedures of the Follow-up visit will 
be performed. Trial sponsor and trial site shall review the rate of unanticipated adverse 
events and determine whether to terminate the trial early.  
Subjects may also be terminated at the request of the Principal Investigator for such 
reasons as unanticipated changes in the Protocol that require an Amendment and make 
the original research methods no longer desirable. In such instances, the subjects may 
be invited to re-consent and re-enroll in the Amended study. 
 


21 
 
 
References 
 
1. 
Jiaravuthisan, M.M., et al., Psoriasis of the nail: anatomy, pathology, clinical 
presentation, and a review of the literature on therapy. J Am Acad Dermatol, 
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Baran, R., The burden of nail psoriasis: an introduction. Dermatology, 2010. 221 
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Rigopoulos, D., Treatment of Nail Psoriasis, in Nail Psoriasis: From A to Z, D. 
Rigopoulos and A. Tosti, Editors. 2014, Springer International Publishing: Cham. 
p. 111-130. 
6. 
Peachey, R.D., R.J. Pye, and R.R. Harman, The treatment of psoriatic nail 
dystrophy with intradermal steroid injections. Br J Dermatol, 1976. 95(1): p. 75-8. 
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Abell, E. and P.D. Samman, Intradermal triamcinolone treatment of nail 
dystrophies. Br J Dermatol, 1973. 89(2): p. 191-7. 
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Bleeker, J.J., Letter: Intradermal triamcinolone acetonide treatment of psoriatic 
nail dystrophy with Port-o-Jet. Br J Dermatol, 1975. 92(4): p. 479. 
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de Berker, D.A. and C.M. Lawrence, A simplified protocol of steroid injection for 
psoriatic nail dystrophy. Br J Dermatol, 1998. 138(1): p. 90-5. 
10. 
Nantel-Battista, M., et al., Treatment of nail psoriasis with intralesional 
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Cutan Med Surg, 2014. 18(1): p. 38-42. 
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Coskey, R.J., Adverse effects of corticosteroids: I. Topical and intralesional. Clin 
Dermatol, 1986. 4(1): p. 155-60. 
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Scher, R.K. and C.R. Daniel, Nails : therapy, diagnosis, surgery. 1990, 
Philadelphia: Saunders. xv, 320 p. 
13. 
Rich, P. and R.K. Scher, Nail Psoriasis Severity Index: a useful tool for 
evaluation of nail psoriasis. J Am Acad Dermatol, 2003. 49(2): p. 206-12. 


22 
 
14. 
Ortonne, J.P., et al., Development and validation of nail psoriasis quality of life 
scale (NPQ10). J Eur Acad Dermatol Venereol, 2010. 24(1): p. 22-7. 
15. 
Chu, T.W., et al., Benefit of different concentrations of intralesional triamcinolone 
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Br J Dermatol, 1961. 73: p. 107-9. 
 
 
 
 
 
 
 


23 
 
APPENDIX  A 
 
Nail Psoriasis Severity Index 
 
 
From Rich, P. and R.K. Scher, Nail Psoriasis Severity Index: a useful tool for evaluation 
of nail psoriasis. J Am Acad Dermatol, 2003. 49(2): p. 206-12. 
 


24 
 
 
 
 
From Rich, P. and R.K. Scher, Nail Psoriasis Severity Index: a useful tool for evaluation 
of nail psoriasis. J Am Acad Dermatol, 2003. 49(2): p. 206-12. 


25 
 
APPENDIX B 
 
NPQ10 
 
Directions: Below is a series of statements. Read each statement. Then, circle the 
answer choice that best describes your experience with nail psoriasis. 
  
1. State the location of your psoriasis of the nails. 
a. Fingernails 
b. Toenails 
c. Both 
2. Would you say that your psoriasis of the nails is mostly: 
a. Very painful 
b. Somewhat painful 
c. Not painful 
3. Because of my psoriasis of the nails, I have difficulty putting my shoes on. 
a. Always 
b. Sometimes 
c. Never 
4. Because of my psoriasis of the nails, I don’t do any of the jobs I usually do 
around the house. 
a. Always 
b. Sometimes 
c. Never 
5. Because of my psoriasis of the nails, I get dressed more slowly than usual. 
a. Always 
b. Sometimes 
c. Never 
6. Because of my psoriasis of the nails, I have trouble putting on my socks (or 
stockings or tights). 
a. Always 
b. Sometimes 
c. Never 
7. Because of my psoriasis of the nails, I have trouble turning my door key. 
a. Always 
b. Sometimes 
c. Never 
8. Because of my psoriasis of the nails, I have trouble driving my car. 
a. Always 
b. Sometimes 
c. Never 
9. Because of my psoriasis of the nails, someone helps me to get dressed. 
a. Always 
b. Sometimes 
c. Never 
10. Because of my psoriasis of the nails, I avoid doing big jobs around the house: 


26 
 
a. Always 
b. Sometimes 
c. Never 
11.  Because of my psoriasis of the nails, I am more irritable than usual, and bad-
tempered with people: 
a. Always 
b. Sometimes 
c. Never 
 
Adapted from Ortonne, J.P., et al., Development and validation of nail psoriasis quality 
of life scale (NPQ10). J Eur Acad Dermatol Venereol, 2010. 24(1): p. 22-7.