A Randomized Clinical Trial to Determine Whether a Novel Plaque-based Dosimetry Strategy Can Improve the Speed of Response to Treatment in Patients With Plaque Psoriasis (Photos)
Phase: NA
Conditions: Psoriasis
Sponsor: University of California, San Francisco

 
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Photos Study 
Title: Excimer LaserPhototherapy Outcomes in the Treatment Of Psoriasis: A randomized 
clinical trial to determine whether a novel plaque-based dosimetry strategy can improve 
the speed of response to treatment in patients with plaque psoriasis (The Photos Study) 
 
Investigators: Ethan Levin MD and John Koo MD 
 
Synopsis 
 
Objectives 
To determine whether a novel plaque-based dosimetry strategy can 
improve the speed of response to excimer laser treatment (Photomedex 
XTRAC ® Velocity) in patients with plaque psoriasis. 
Methodology 
Randomized, assessor-blinded, bilateral comparison clinical trial 
Study Period  
10 weeks 
Number of Subjects 
Up to 30  
Dosing Regimen 
Each patient will receive plaque-based dosing on one side of the body and 
conventional dosing on the contralateral side. Patients will be treated 1-2 
times per week for a maximum of 10 treatments.   
Diagnosis and Main 
Criteria for Inclusion 
into the Study 
Males and females subjects at least 18 years of age with plaque-type 
psoriasis affecting a body surface area ≤ 10 percent.  
Endpoints 
Primary Endpoint: 
1. Change in mPASI of target lesions on each side of the body over time 
Secondary Endpoints: 
2. Number of treatments to reach a reduction in mPASI of 75% 
3. Percentage of patients reaching a reduction in mPASI of 75% after 10 
treatments 
4. Change in PGA of each side of the body over time  
5. Percentage of patients reaching PGA of 0 or 1 after 10 treatments  
6. Number of treatments to reach PGA of 0 or 1 
Safety: Safety will be assessed by tabulations of adverse events (AE’s), 
with all AE’s during the study recorded at each visit.  
Statistical Methods 
Statistical significance will be based on resulting p-values of 0.05 or less 
Ethical Considerations 
This study will be conducted in accordance with applicable laws and 
regulations and according to the recommendations of International 
Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines 
and those of the Declaration of Helsinki (Edinburgh, 2000); only after 
approval for the study has been obtained from the relevant regulatory 
authority and relevant independent ethics committee (IEC). The 
institutional review board (IRB)/IEC must review and approve the 
protocol and informed consent form (ICF) before any subjects are 
enrolled. The subject must be consented using the approved ICF before 
any procedures specified in the protocol are performed. 
 
 
 
12/15/14

 
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STUDY TITLE:ExcimerLaser Phototherapy Outcomes in the Treatment Of Psoriasis: 
Arandomized clinical trialto determine whether a novel plaque-based dosimetry strategy 
can improve the speed of response to treatmentin patients with plaque psoriasis (The 
Photos Study) 
 
 
 
ABSTRACT 
Objectives:To determine whether a novel plaque-based dosimetry strategy can improve 
the speed of response to excimer laser treatment in patients with plaque psoriasis. 
Design: Randomized, assessor-blinded, bilateral comparison clinical trial 
Subjects: Consecutive sample of patients with generalized plaque type psoriasis seen at 
the University of California San Francisco Psoriasis and Skin Treatment Center 
Variables: 
Predictor Variables – plaque-based dosimetry vs. induration and skin type guesstimated 
dosimetry (Appendix A-1) 
Outcome Variables – clearing of target plaque (modified PASI) over time 
 
SPECIFIC AIMS 
 To assess the difference in the rate of improvement of plaque psoriasis treated with 
excimer laser using plaque-based dosimetry compared with current treatment 
guidelines. 
 
 

 
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A.  BACKGROUND AND RATIONALE: 
Psoriasis is a chronic inflammatory condition that is associated with significant 
morbidityand affects7.5 million Americans.1Patients with untreated generalized psoriasis 
suffer from adecreased quality of life, comparable to patients living with conditions such as 
congestive heart failure, diabetes mellitus and breast cancer.2Further, patients with 
psoriasis are more likely to be depressed and experience suicidal ideation compared to the 
general population.  
 
While there are many treatments for psoriasis including topical therapies, oral 
agents and injectable biologic medications, one of the safest and most widely used is 
ultraviolet (UV)-B phototherapy.1Excimer laser therapy is the most convenient modality of 
phototherapy, clearing psoriatic plaques in less than half the number of treatments needed 
with traditional UVB booth phototherapy.3-5  In contrast to traditional UVB phototherapy, 
which exposes the whole body, excimer laser therapy targets only lesional plaques. As a 
result, the clinician is able to dose more aggressively, resulting in faster clearance.  
 
The current standard of care is to determine dosimetry based on skin type and 
plaque induration (see Appendix A-1).  This ‘guesstimated’ dose is extrapolated from whole 
body UVB box phototherapy. An alternative method is to use a dose that is 2-4 times higher 
than the minimal erythema dose (MED) of non-psoriatic skin, a strategy is known as 
“supra-erythemogenic phototherapy” (see Appendix A-2).6However, non-psoriatic skin is 
much less tolerantto UVB radiation than psoriatic plaques. Thus, a more rational approach 

 
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to determining the optimal dosimetry than either of the above strategies can be devised 
based on direct testing ofpsoriatic plaques. 
 
Prior studies have shown thatthe dose (mj/cm2) of ultraviolet B administeredis the 
single most important factor in determining both clearance and duration of therapeutic 
response of psoriatic plaques to excimer laser phototherapy (5–7). Interestingly, the 
number of phototherapy sessions is not as critical. Based on these observations, it is best to 
treat the patient with a dosimetry that is as high as possible, without causing discomfort or 
blistering to the psoriatic plaques.  In order to determine the optimal dosimetry strategy, 
we propose a head-to-head, bilateral comparison clinical trial that compares plaque-based 
dosimetryto the current standard of care. 
 
B.  STUDY OBJECTIVE 
The primary objective of this study is to determine whether a novel plaque-based 
dosimetry strategy can improve the speed of response toexcimer laser treatment in 
patients with plaque psoriasis. 
 
C. STUDY DESIGN 
This is a randomized, assessor-blindedclinical trial to determine whether a novel 
plaque-based dosimetry strategy can improve the speed of response to excimer laser 
treatment (measured by change in Modified Psoriasis Area and Severity Index [mPASI] of 
target lesion over time) in patients with plaque psoriasis. To minimize the effect of inter-
subject variability in response to treatment, this study will use a bilateral comparison 

 
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design.  Each patient will receive plaque-based dosing on one side of the body and 
conventional dosing (Appendix A-1) on the contralateral side. This design is based on the 
assumption that psoriasis usually affects patients in a symmetric distribution (e.g., knees 
and elbows) and the effect of excimer laser phototherapy is limited to the treated plaque.  
The side of the body treated with plaque-based dosimetry will be assigned using a table of 
random numbers.  The assessor will be blinded to the treatment group.Each patient will be 
treated 1-2 times per week at the discretion of the investigator for a maximum of 10 
treatments.  A summary of study procedures is described in Appendix B. 
 
D. STUDY SUBJECTS 
Target Population: Patients with generalized plaque type psoriasis 
Accessible Population: Patients with generalized plaque type psoriasis seen at the 
University of California San Francisco Psoriasis and Skin Treatment Center 
Inclusion Criteria: 
1) Diagnosis of chronic plaque psoriasis for at least 6 months 
2) Age ≥ 18 years  
3) Body surface area affected ≤ 10 percent 
4) Presence of at least one pair of bilateral target lesions with an area of at least 20 cm2per 
target lesion.  The bilateral target lesions must be present in the same category of 
anatomical region (e.g., bilateral lower extremities, bilateral upper extremities or bilateral 
trunk). 
 
Exclusion Criteria: 
1) active or past history of erythrodermic psoriasis, guttate psoriasis, or pustular psoriasis 
2) history of photosensitivity disorder 
3) history of malignant melanoma 
4) active, invasive non-melanoma skin carcinoma  
5) Fitzpatrick Skin Type I 

 
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6) Subject has received UVB phototherapy or any topical anti-psoriatic therapy within two 
weeks prior to starting the study. 
7) Subject has received systemic or topical psoralen-UVA photochemotherapy within four 
weeks prior to starting the study. 
8) Subject has received biologic therapy within three months of starting the study. 
Sampling: Consecutive sample 
Recruitment: Eligible patients will be recruited from the Psoriasis and Skin Treatment 
Center outpatient clinic and from the center’s research study hotline.  
Ineligible patients or those who decline to participate will be offered the standard of care of 
psoriasis treatment. 
 
E. STUDY ENDPOINTS 
Primary Endpoint: 
1. Change in mPASI of target lesions on each side of the body over time 
 
Secondary Endpoints: 
2. Number of treatment to reach a reduction in mPASI of 75% 
3. Percentage of patients reaching a reduction in mPASI of 75% after 10 treatments 
4. Change in PGA of each side of the body over time  
5. Percentage of patients reaching PGA of 0 or 1 after 10 treatments  
6. Number of treatments to reach PGA of 0 or 1 
7. Change in PASI over time for each side of body 
8. Percentage of patients reaching a 75% reduction in PASI after 10 treatments 
9. Change in Patient’s Global Assessment of each side of body over time  
 
The mPASI for each target lesion will be calculated based on erythema, induration, scaling 
and area scores. Erythema, induration and scaling will be graded on a four-point scale 
including: [0] none, [1] slight, [2] mild, [3] moderate and [4] severe.  The area score will be 
graded on a six-point scale based on percentage of the target lesion involved: [0] clear, [1] 
<10%, [2] 10-30%, [3] 30-50%, [4] 50-70%, [5] 70-90%, or [6] 90-100%.  This percentage 

 
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will be calculated as one minus the proportion of the target lesion cleared compared to the 
pretreatment baseline.  
 
The PGA is a measurement determined by the investigator that gives an overall clinical 
impression of the psoriatic lesions of the patient.  The PGA is graded on a seven-point scale 
including: [0] clear, [1] almost clear, [2] mild, [3] mild-to-moderate, [4] moderate, [5] 
moderate-to-severe and [6] severe.  Four characteristics of the patient’s psoriatic plaques 
are considered when determining the PGA including erythema, induration, scaling and total 
area affected.  
 
F. STUDY TREATMENTS  
Control:  Dosimetry based on induration and skin type of subject (see Appendix A-1) 
Intervention: Dosimetry based on plaque-based testing 
Method of Assigning Subjects Treatment 
Up to 30 eligible patients will randomly assigned to receive plaque-based dosing on one-
half of their body and conventional dosing on the other side.  The side of the body treated 
with plaque-based dosimetry will be assigned using a table of random numbers. Patients 
will be treated with the Photomedex XTRAC® Velocity, the latest version of the excimer 
laser. 
Blinding  
Due to the objectives of the study, the identity of test and control treatments will not be 
known to investigators or patients.  Research staff administering the treatments will know 
the treatment assignment so they can correctly treat the patients.  The following study 
procedures will be in place to ensure blinding is maintained.  
 Access to the randomization code will be strictly controlled.   
 The assessor will be blinded to the treatment group 
 One investigator will strictly assess the outcome variables while a different investigator 
will perform the plaque-based testing and administer the excimer treatments.   

 
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 Target plaques on both sides of the body will be tested with the new dosimetry device.  
Therefore, the results of the testing (ink marks, erythema, etc.) will not clue the blinded 
assessor as to the treatment assignment. 
The study blind will be broken on completion of the clinical study and after the study database 
has been locked.  Patients can be made aware of treatment assignments at this time. During the 
study, the blind may be broken only in emergencies when knowledge of the patient’s treatment 
group is necessary for further patient management. The principal investigator will make this 
determination in consultation with the patient. 
 
G. STUDY PROCEDURES AND GUIDELINES 
A Schedule of Events representing the required testing procedures to be performed for the 
duration of the study is diagrammed in Appendix B. 
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed and 
dated by the subject.  If appropriate, assent must also be obtained prior to conducting any 
study-related activities. 
 
Determining dosimetry based on plaque-based testing: 
Plaque-based testing will be performed in least one but not more than three anatomical 
areas, namely the trunk, arms and legs.  Test lesions need to be at least 2 cm by 2 cm. They 
will be marked with an inkpad to indicate orientation, photographed and diagrammed in 
source documentation. These lesions will be treated with a specialized hand piece that can 
deliver up to 9 different doses of ultraviolet B simultaneously in a 3 by 3 matrix (see 
Appendix C).  The 9 distinct doses are delivered in steps of 10% of the maximum dose 
(100%, 90%, 80%, etc.). For Fitzpatrick Type II or III skin, this will include doses of 
2100milliJoules (mJ), 1890 mJ, 1680 mJ, 1470 mJ, 1260 mJ, 1050 mJ, 840 mJ, 630 mJ, and 
420 mJ. For Fitzpatrick Type IV, V or VI skin, this will include doses of 4000 mJ, 3600 mJ, 
3200 mJ, 2800 mJ, 2400 mJ, 2000 mJ, 1600 mJ, 1200 mJ, and 800 mJ. The plaque will be 
inspected and photographed 24-48 hours after the initial doses to determine the minimal 

 
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blistering dose (MBD). The MBDis the lowest dose of ultraviolet B that results in clinically 
perceptible blistering, usually manifest as slight crusting or epidermal erosion. The patient 
will then be treated with a starting dose that is 20% less the MBD in each respective 
anatomic area. Subsequent dosing will be determined according to the current standard of 
care (Appendix A-1, Part B). 
 
Clinical Assessments 
Concomitant Medications 
All concomitant medication and concurrent therapies will be documented at Screening and 
at Visits 1, 3, 5, 7, 9, and at early termination when applicable.  Dose, route, unit frequency 
of administration, and indication for administration and dates of medication will be 
captured. 
Demographics  
Demographic information (date of birth, gender, race) will be recorded at Screening. 
Medical History  
Relevant medical history, including history of current disease, other pertinent respiratory 
history, and information regarding underlying diseases will be recorded at Screening. 
Physical Examination 
A complete physical examination will be performed by either the investigator or a 
subinvestigator who is a physician at screening. New abnormal physical exam findings 
must be documented and will be followed by a physician or other qualified staff at the next 
scheduled visit. 
Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the study. 
Duration (start and stop dates), severity/grade, outcome, treatment and relation to study 
drug will be recorded on the case report form (CRF). 
 
H. EVALUATIONS BY VISIT 
 
Screening Visit (Visit 0) 
 
Review and obtain written informed consent and HIPAA authorization 

 
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 
Assign subject unique screening number 
 
Review demographics data 
 
Review medical history including all medications 
 
Review inclusion criteria and exclusion criteria 
 
Perform physical examination, including a careful skin exam 
 
If patient qualifies, administer test dose to psoriasis plaques 
 
Visits 1-10 
 Review any adverse events or side effects from treatment 
 Review concomitant medications (only at Screening and Visits 1, 3, 5, 7 and 9) 
 Skin assessments 
 Treatment with Excimer Laser 
 Photograph Psoriasis (only at Visit 1 and Visit 10) 
 
Early Withdrawal Visit 
 Record any adverse events 
 Record changes to concomitant medications. 
 Perform complete physical examination. 
 
I.  ADVERSE Experience REPORTING AND DOCUMENTATION 
An AE is defined as any undesirable event that occurs to a study participant whether or not 
it is believed to be related to the study treatment.  Examples include: 
 Any sign, symptom and/or event that is an undesirable change from the subject’s 
baseline/entry status, e.g. an increase in severity or frequency of  a pre-existing 
abnormality or disorder; 
 Any illness, whether apparent to be related or unrelated to the study treatment; 
 Injury or accidents. 
All AE’s, whether observed by the Investigator or reported by the subject, and whether or 
not thought to be treatment-related, must be fully and completely documented on the 

 
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Adverse Event Form or on a Serious Adverse Event Form.  Assessment of severity and 
relationship to the study treatment will be based on specific definitions and reported. 
 
Grading and Severity 
The severity of an adverse event should be scored, based on the Investigator’s clinical 
judgment, according to the following scale: 
• 
Mild – the AE does not interfere in a significant manner with the subject’s 
normal activity/functioning level.  It may be an annoyance. 
• 
Moderate – the AE produces some impairment of activity/functioning, but is 
not hazardous to health. 
• 
Severe – the AE produces significant impairment of activity/functioning or 
incapacitation, and is a definite hazard to the subject’s health. 
 
The relationship of an AE to the study treatment should be assessed by the Investigator 
according to the following definitions: 
• 
Definitely Unrelated – events which occur prior to the administration of 
study treatment or events which cannot be even remotely related to study 
treatment. 
• 
Unlikely – there is no reasonable temporal association between the study 
treatment and the event, and the event could have been produced by the subject’s 
clinical condition or other therapies concomitantly administered to the subject. 
• 
Possible – the event may or may not follow a reasonable temporal sequence 
from administration of study treatment, but seems to be the type of medical 
condition that cannot be dismissed as unlikely.  The event could have been 
produced or mimicked by the subject’s clinical state or other therapies 
concomitantly administered to the subject. 
• 
Probable – the event follows a reasonable temporal sequence from 
administration of study treatment (i.e. abates upon discontinuation of study 
treatment) and cannot be reasonably explained by the known characteristics of the 
subject’s clinical state. 

 
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• 
Related – events that have no uncertainty in their relationship to the 
administration of study treatment. 
 
A Serious Adverse Event (SAE) includes, but is not limited to, an event that:  (1) is fatal;  (2) 
is life threatening (the subject was at risk of death at the time of the event; this does not 
refer to an event which might have caused death if it had occurred in a more severe form;  
(3) requires in-subject hospitalization or prolongs an existing hospitalization;  (4) is a 
persistent or significant disability/incapacity;  or (5) is a congenital anomaly/birth defect. 
Study sites will document all SAEs that occur (whether or not related to study treatment) 
per UCSF CHR Guidelines.  The collection period for all SAEs will begin after informed 
consent is obtained and end after procedures for the final study visit have been completed. 
In accordance with the standard operating procedures and policies of the local Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC), the site investigator will report 
SAEs to the IRB/IEC.   
 
J. PROTOCOL VIOLATIONS 
A protocol violation occurs when the subject or investigator fails to adhere to significant 
protocol requirements affecting the inclusion, exclusion, subject safety and primary 
endpoint criteria. Protocol violations for this study include, but are not limited to, the 
following: 
 Failure to meet inclusion/exclusion criteria 
 Use of a prohibited concomitant medication 
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a protocol 
violation. The investigator will determine if a protocol violation will result in withdrawal of 
a subject. 
When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by a 
Sponsor representative and the Investigator. A copy of the form will be filed in the site’s 
regulatory binder and in the Sponsor’s files. 

 
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K. STATISTICAL METHODS AND CONSIDERATIONS 
The primary outcome variable is Modified Psoriasis Area Severity Index (mPASI) for each 
target lesionat each study visit. Scores will be compared to Visit 1 in order to calculate 
change from baseline. The scores for the other outcome variables including Physicians 
Global Assessment (PGA) of each side of the body, PASI of each side of the body, and 
Patient’s Global assessment will also be compared to baseline. 
Statistical significance will be based on resulting p-values of 0.05 or less.  Last observation 
carried forward (LOCF) will be used to impute missing data.  Analyses will be conducted on 
an intent-to-treat (ITT) population (all subjects enrolled and receiving the treatments).  
Analyses on the per-protocol (PP) population will be considered supportive of the ITT 
analyses.  Subjects will be eligible for the PP analyses if they complete Visit 10 without any 
noteworthy study protocol violations (i.e. patient or investigator activity that could have 
possibly interfered with the therapeutic administration of the treatment or the precise 
evaluation of treatment efficacy). 
 
Sample Size Determination 
The primary null hypothesis is that there is no difference in the change in mPASI over time 
in patients treated with excimer laser using plaque-based dosimetrycompared to 
conventional dosimetry. The alternative hypothesis is two-sided. 
Effect size: 
While the change in mPASI over time is not reported in the literature with excimer laser, 
20% faster improvementusing plaque-based dosimetry (compared with conventional 
dosimetry) would be clinically significant. This would lead to a patient achieving a great 
response of their psoriatic lesions in at least two less treatments, since the average time to 
response is 10 treatments.   
Estimate of Variability (standard deviation):20%, based on published studies using 
excimer laser to treat plaque psoriasis4 

 
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E/S ratio: 1 
α = 0.05 β = 0.20 (power = 0.80) – minimum sample size = 17 patients Per groupx 1.2, 
assume 20% loss to follow-up/dropout = 20 patients per group 
Comment 
Effect size and variability were based on prior literature using excimer laser treatment 
methods in plaque psoriasis 4,6.   This is a two-tailed test because we do not know for 
certain before hand that the effect size of the novel treatment will increase the change in 
PGA over time.  If it decreased the change in PGA over time, this would be clinically relevant 
and thus we want to account for this outcome with our statistical test. Alpha and beta were 
set at 0.05 and 0.20 (power of 0.80).  Thus, there is a 5% chance that we would observe a 
difference in the change in PGA over time based on chance alone, eventhough there is no 
real difference in the true population.  There is an 80% chance we would detect an 
association of the given effect size or greater if it exists.  These are standard α and β values. 
This particular research question does not require a lower α to avoid potential Type I error 
- there is no theoretical basis as to why plaque-based dosimetry would result in more harm 
to the patient. Similarly, since the conventional dosimetry method is safe and well 
tolerated, there is little reason to require a more stringent β value. 
 
L. DATA COLLECTION, RETENTION AND MONITORING 
Data Collection Instruments 
The Investigator will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each treated subject.   
Study personnel will enter data from source documents corresponding to a subject’s visit 
into the protocol-specific paper Case Report Form (CRF) when the information 
corresponding to that visit is available.  Subjects will not be identified by name in the study 
database or on any study documents, but will be identified by a site number, subject 
number and initials. 

 
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If a correction is made on a CRF, the study staff member will line through the incorrect 
data, write in the correct data and initial and date the change. 
The Investigator is responsible for all information collected on subjects enrolled in this 
study.  All data collected during the course of this study must be reviewed and verified for 
completeness and accuracy by the Investigator.  A copy of the CRF will remain at the 
Investigator’s site at the completion of the study. 
Data Management 
The data will be entered into a Microsoft access database and stored on an encrypted, 
password-protected research server. Data will be exported from Microsoft access to Stata 
for analysis. Appropriate backup copies of the database and related software files will be 
maintained.  
Availability and Retention of Investigational Records 
The Investigator must make study data accessible to authorized representatives of the 
Sponsor (or designee), IRB/IEC, and Regulatory Agency (e.g., FDA) inspectors upon 
request.  A file for each subject must be maintained that includes the signed Informed 
Consent, HIPAA Authorization and Assent Form and copies of all source documentation 
related to that subject.  The Investigator must ensure the reliability and availability of 
source documents from which the information on the CRF was derived. 
All study documents (patient files, signed informed consent forms, copies of CRFs, Study 
File Notebook, etc.) must be kept secured for a period of two years.  There may be other 
circumstances for which the Sponsor is required to maintain study records and, therefore, 
the Sponsor should be contacted prior to removing study records for any reason. 
Subject Confidentiality 
In order to maintain subject confidentiality, only a site number, subject number and subject 
initials will identify all study subjects on CRFs and other documentation submitted to the 
Sponsor.  Additional subject confidentiality issues (if applicable) are covered in the Clinical 
Study Agreement. 

 
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M. ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
The study will be conducted according to the Declaration of Helsinki, Protection of Human 
Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and Obligations of 
Clinical Investigators (21 CFR 312). 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other 
records will be identified by a coded number and initials only.  All study records will be 
kept in a locked file cabinet and code sheets linking a patient’s name to a patient 
identification number will be stored separately in another locked file cabinet.  Clinical 
information will not be released without written permission of the subject, except as 
necessary for monitoring by the FDA.  The Investigator must also comply with all 
applicable privacy regulations (e.g., Health Insurance Portability and Accountability Act of 
1996, EU Data Protection Directive 95/46/EC). 
Protocol Amendments 
Any amendment to the protocol will be written by the investigator.  Protocol amendments 
cannot be implemented without prior written IRB/IEC approval except as necessary to 
eliminate immediate safety hazards to patients.  A protocol amendment intended to 
eliminate an apparent immediate hazard to patients may be implemented immediately, 
provided the IRBs are notified within five working days. 
Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form will be reviewed and approved by the IRB/IEC of each 
participating center prior to study initiation.  Serious adverse experiences regardless of 
causality will be reported to the IRB/IEC in accordance with the standard operating 
procedures and policies of the IRB/IEC, and the Investigator will keep the IRB/IEC 
informed as to the progress of the study.  The Investigator will obtain assurance of IRB/IEC 
compliance with regulations. 

 
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Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 
will be submitted to the IRB/IEC.  The IRB/IECs written unconditional approval of the 
study protocol and the informed consent form will be in the possession of the Investigator 
before the study is initiated.  The IRB/IECs unconditional approval statement will be 
transmitted by the Investigator to the Sponsor prior to the shipment of studysupplies to 
the site.  This approval must refer to the study by exact protocol title and number and 
should identify the documents reviewed and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without 
prior written IRB/IEC approval except when necessary to eliminate immediate hazards to 
the patients or when the change(s) involves only logistical or administrative aspects of the 
study.  Such modifications will be submitted to the IRB/IEC and written verification that 
the modification was submitted and subsequently approved should be obtained.   
The IRB/IEC must be informed of revisions to other documents originally submitted for 
review; serious and/or unexpected adverse experiences occurring during the study in 
accordance with the standard operating procedures and policies of the IRB; new 
information that may affect adversely the safety of the patients of the conduct of the study; 
an annual update and/or request for re-approval; and when the study has been completed. 
Informed Consent Form  
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH GCP, 
US Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 
50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act 
(HIPAA, if applicable), and local regulations. 
The Investigator will prepare the informed consent form, assent and HIPAA authorization 
and provide the documents to the Sponsor or designee for approval prior to submission to 
the IRB/IEC.  The consent form generated by the Investigator must be acceptable to the 
Sponsor and be approved by the IRB/IEC.  The written consent document will embody the 

 
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elements of informed consent as described in the International Conference on 
Harmonisation and will also comply with local regulations. The Investigator will send an 
IRB/IEC-approved copy of the Informed Consent Form to the Sponsor (or designee) for the 
study file. 
A properly executed, written, informed consent will be obtained from each subject prior to 
entering the subject into the trial.  Information should be given in both oral and written 
form and subjects must be given ample opportunity to inquire about details of the study.  If 
appropriate and required by the local IRB/IEC, assent from the subject will also be 
obtained.  If a subject is unable to sign the informed consent form (ICF) and the HIPAA 
authorization, a legal representative may sign for the subject.   A copy of the signed consent 
form (and assent) will be given to the subject of the subject and the original will be 
maintained with the subject’s records. 
Publications  
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among the 
study Sponsor and participating institutions.  The publication or presentation of any study 
results shall comply with all applicable privacy laws, including, but not limited to, the 
Health Insurance Portability and Accountability Act of 1996.  
Investigator Responsibilities 
1. 
Conduct the study in accordance with the protocol and only make changes after 
notifying the Sponsor (or designee), except when to protect the safety, rights or welfare of 
subjects. 
2. 
Personally conduct or supervise the study (or investigation). 
3. 
Ensure that the requirements relating to obtaining informed consent and IRB 
review and approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4. 
Report to the Sponsor or designee any AEs that occur in the course of the study, in 
accordance with §21 CFR 312.64. 

 
Protocol 14-15201 
 
Proprietary and Confidential 
 
5. 
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments. 
6. 
Maintain adequate and accurate records in accordance with §21 CFR 312.62 and to 
make those records available for inspection with the Sponsor (or designee). 
7. 
Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study. 
8. 
Promptly report to the IRB and the Sponsor (or designee) all changes in the 
research activity and all unanticipated problems involving risks to subjects or others (to 
include amendments and IND safety reports). 
9. 
Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10. 
Comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements listed in § 21 CFR part 312. 
 
 

 
Protocol 14-15201 
 
Proprietary and Confidential 
 
REFERENCES 
1. 
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, 
Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis 
and Psoriatic Arthritis in the United States: Findings From the National Psoriasis 
Foundation Surveys, 2003-2011. JAMA dermatology. 2013. 
2. 
Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as 
much disability as other major medical diseases. Journal of the American Academy of 
Dermatology. 1999;41(3 Pt 1):401-407. 
3. 
Asawanonda P, Anderson RR, Chang Y, Taylor CR. 308-nm excimer laser for the 
treatment of psoriasis: a dose-response study. Archives of dermatology. 
2000;136(5):619-624. 
4. 
Feldman SR, Mellen BG, Housman TS, et al. Efficacy of the 308-nm excimer laser for 
treatment of psoriasis: results of a multicenter study. Journal of the American 
Academy of Dermatology. 2002;46(6):900-906. 
5. 
Trehan M, Taylor CR. High-dose 308-nm excimer laser for the treatment of psoriasis. 
Journal of the American Academy of Dermatology. 2002;46(5):732-737. 
6. 
Gattu S, Pang ML, Pugashetti R, et al. Pilot evaluation of supra-erythemogenic 
phototherapy with excimer laser in the treatment of patients with moderate to 
severe plaque psoriasis. The Journal of dermatological treatment. 2010;21(1):54-60. 
 
 
 

 
Protocol 14-15201 
 
Proprietary and Confidential 
 
Appendix A-1: Conventional Excimer Laser Treatment Guidelines 
 
 
XTRACUltraandXTRACVelocityExcimerLaserProtocol 
A.Determiningdoseforfirsttreatmentofpsoriasis 
Fitzpatrickskintype 
Plaque 
Induration 
1–3 
4–6 
thickness 
score 
(mJ/cm2) 
(mJ/cm2) 
Mild 
1 
300 
400 
Moderate 
2 
500 
600 
Severe 
3 
700 
900 
B.Determiningdoseforsubsequenttreatmentsofpsoriasis 
Clinicalobservation 
Moderate/ 
Minimal 
Considerable 
severe 
Noeffect 
effect 
Goodeffect improvement 
erythema 
Noerythema at  Slight 
Mild-to- 
Significant 
Withor12–
24hours 
 erythemaat 
moderate 
improvement 
without 
andandno plaque 
 
12–24hrbut 
erythema
 
withplaque 
blistering improvement 
 
nosignificant 
response 
thinningor 
 
improvement 
at12–24 
reducedscalinesshr
 
orpigmentation 
occurred 
 
Increasedose 
Increasedose 
Maintain 
Maintaindoseor 
Reducedose by 
25% 
 by15% 
dose 
reducedoseby 
by25%(treat 
15%(reduction 
aroundany 
intendedto 
blisteredarea; 
minimize 
donottreat 
hyperpigmentation  blisteredarea 
effectand/orto 
untilhealed 
avoidincreased 
withcrust 
erythema) 
disappeared) 
Source: XTRAC treatment guidelines. 12–95359-01 Rev. C. 
Note:Thisdosingguideline 
isprovided 
forguidance 
purposes 
only.Eachpatientmayreactdifferently,therefore,thephysicianshoulddeterminetheactualtreatme
ntregimensbasedonpatient historyandtheirownclinicalexperienceand expertise. 
XTRACO
R  clinicalreferenceguide:DosingguidelinefortargetedUVBphototherapyofpsoriasis. 

Principal Investigator: Ethan Levin 
 
22
 
Appendix A-2: Determining Dose for First Treatment of Psoriasis Based on MED and Plaque 
Characteristics.   First Treatment Dose = MED x Multiplier 
 
Plaque Location 
Plaque Thickness 
Plaque Tan 
Multiplier for First 
Dose 
Knees, Elbows, 
Hands, Feet 
Thick, Tough 
Tanned 
4 (or 400%) 
Knees, Elbows, 
Hands, Feet 
Thick, Tough 
Not Tanned 
3 (or 300%) 
Knees, Elbows, 
Hands, Feet 
Thin, Moderate 
Tanned 
3 (or 300%) 
Knees, Elbows, 
Hands, Feet 
Thin, Moderate 
Not Tanned 
2 (or 200%) 
All Other Locations 
Thick, Tough 
Tanned 
3 (or 300%) 
All Other Locations 
Thick, Tough 
Not Tanned 
2 (or 200%) 
Knees, Elbows, 
Hands, Feet 
Thick, Tough 
Tanned 
4 (or 400%) 

Principal Investigator: Ethan Levin 
 
23 
Appendix B: Summary of Study Procedures 
 
Visit Number 
0 - Screening 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Inclusion/Exclusion Criteria 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
 
 
 
 
 
 
 
 
 
 
 
Medical History + Physical Exam 
 
 
 
 
 
 
 
 
 
 
 
Fitzpatrick Skin Typing 
 
 
 
 
 
 
 
 
 
 
 
Plaque-based Testing 
 
 
 
 
 
 
 
 
 
 
 
Physician’s Global Assessment, each 
side 
 
 
 
 
 
 
 
 
 
 
 
Patient’s Global Assessment, each 
side 
 
 
 
 
 
 
 
 
 
 
 
Modified Psoriasis Area and Severity 
Index, each side 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis Area and Severity Index, 
target lesion 
 
 
 
 
 
 
 
 
 
 
 
Reconcile Concurrent medications 
 
 
 
 
 
 
 
 
 
 
 
Adverse Events 
 
 
 
 
 
 
 
 
 
 
 
Full body photographs 
 
 
1 
Excimer Laser Rx2 
 
 
 
 
 
 
 
 
 
 
 
Completion Paperwork 
 
 
 
 
 
 
 
 
 
 
 
1Second set of full body photographs will be captured once the patient reaches a PGA or 0 or 1 on one side of the body OR at the last study visit 
2Patients will be treated excimer laser 1-2x per week at the discretion of the provider for a maximum of 10 treatments over 10 weeks   
 
 
 

Principal Investigator: Ethan Levin 
 
24
Appendix C - Matrix Dosimetry Tip for Plaque Based Testing 
Matrix Dosimetry Tip includes a series of 9 small reflective filters that reduce the delivered 
308 nm UVB by small, controlled, incremental steps of 10%, as shown in the figure below.