Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
Phase: NA
Conditions: Psoriasis
Sponsor: University Hospitals Cleveland Medical Center

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 1 of 13 
 
 
1. BACKGROUND/RATIONALE 
 
Psoriasis is a prevalent global skin disease (1). Psoriasis is not simply an inflammatory disease of 
the skin but also a systemic inflammatory condition that carries a higher risk for cardiovascular 
disease and other systemic comorbidities. Certain inflammatory markers are known to be elevated 
in the serum of patients with psoriasis. Some of these markers may correlate with severity and 
extent of skin lesions (i.e. PASI score), while others may not (2). Therapies that decrease the 
inflammation present in the skin could lead to a systemic decrease in inflammatory mediators, 
thereby lowering the risk for developing comorbidities. UVB phototherapy has been employed in 
the treatment of psoriasis for decades. The UVB wavelengths most effective for psoriasis (i.e. 
action spectrum) falls within 308-313 nm. Narrowband UVB (311 nm) is the most popular 
phototherapeutic modality for full body treatment, in which unaffected normal skin is also exposed 
to UV light. Lesion targeted NUVB became feasible upon the introduction of 308 nm excimer 
lasers. This strategy not only spared normal skin from unnecessary UV, but also allowed for higher 
doses of UV to be delivered on lesional skin, within a reasonable amount of time. Currently, 
excimer laser treatment of psoriasis is an FDA-approved therapy. Whereas changes in serum 
resistin have been demonstrated after NUVB (3), there is no data regarding targeted UVB excimer 
laser treatments and serum inflammatory markers. 
 
Hyperpigmentation is a common adverse effect reported after targeted UVB phototherapy (4,5). In 
our clinical experience, the Photomedex Xtrac® Velocity Excimer Laser has resulted in minimal to 
no hyperpigmentation after psoriasis plaque treatment. Furthermore, there is a lack of research 
objectively measuring hyperpigmentation and erythema after excimer laser treatment. 
 
2. STUDY OBJECTIVES/HYPOTHESIS 
 
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis 
affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer 
laser treatment. 
 
We hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will 
decrease the levels of serum inflammatory markers. We hypothesize that treatment will decrease 
plaque erythema and will result in minimal hyperpigmentation 
  
3. STUDY DESIGN 
 
We plan on enrolling 24-27 psoriasis patients for this research study. 
  
 
 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 2 of 13 
 
 
3.1  STUDY POPULATION 
 
3.1.1 Inclusion Criteria 
 
 Age 18 years and older 
 Male or female with diagnosis of psoriasis 
 Psoriasis involvement of 5-15% BSA 
 Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) 
for at least 4 weeks 
 Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks 
 Fitzpatrick Skin Types I-VI 
 
3.1.2 Exclusion Criteria 
 
 Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, 
porphyria, severe polymorphous light eruption, solar urticaria) 
 Any suspicion that the psoriasis is of the photosensitive variant.  
 Any medical condition that could be aggravated or may cause extreme discomfort during 
the study period.   
 
3.2 STUDY PROCEDURES 
 
3.2.1 Dose Determination:  
The initial dose will be determined by one of the following methods:  
 
 Sunburn Test/Minimal Erythema Dose (MED) Test: This test will be 
performed during the screening visit to determine the initial dose of the Excimer 
laser. This involves exposing spots on the buttock or lower back to increasing 
doses of UVB via the Excimer laser. The redness generated from these exposures 
will be evaluated at Visit 2 by visual evaluation to determine the initial laser dose. 
The initial dose will be anywhere from 1-4x the MED. Patients who choose this 
method will have to come back for Visit 2 to determine the dose. 
 
 Visual MED Test: If this method is chosen, a study doctor will visually 
determined the MED during the screening visit based on the patient’s skin type 
and thickness of the psoriasis plaques. Patients who choose this method will not 
have to come in for Visit 2. 
  
3.2.2 Excimer Laser Irradiation: This is a standard clinical procedure approved for the 
treatment of psoriasis. Initial laser dose will be anywhere from 1-4x the MED, 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 3 of 13 
 
 
depending on thickness of the plaque. Escalation will be 25-50% increase in dose per 
treatment if there is no residual erythema, 25% increase per treatment if there is mild 
residual erythema, and 0% increase per treatment if there is moderate residual erythema. 
Investigator also has the option to skip a treatment, if there is above moderate erythema, 
or significant patient discomfort exists.  Patients will receive treatment twice a week 
until one of the following: 
 PASI 75 Improvement 
 Patient reaches a maximum of 20 treatments 
 
3.2.3 Optional Punch Biopsy: Up to 8mm punch biopsies may be taken at the screening visit 
and final visit from a psoriasis lesion. The tissue samples will be used for histology and 
undergo standard H&E staining to evaluate the differences before and after Excimer 
laser treatment. Patients may still participate in this study if they choose to not donate 
punch biopsies. This procedure involves the removal of a small circle of skin (pencil 
eraser-sized) using a cookie cutter-like instrument. Lidocaine is used to numb the area 
to be removed before obtaining the biopsy and then 1-2 stitches are used per biopsy site 
to prevent bleeding, speed healing and improve the appearance. This procedure may last 
up to an hour depending on the number of biopsy sites. The stitches are then removed 7-
14 days later. 
 
3.2.4 PASI Scoring: PASI will be determined for all subject at the Screening Visit, Visit 8, 
Visit 16, at Visit 23 Final/Termination Visit and, if applicable, the 3 month follow-up 
visit The PASI is a measure of psoriatic disease severity taking into account qualitative 
lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area 
involvement on defined anatomical regions. The PASI is a validated instrument that has 
become standard in clinical trials for psoriasis.  Psoriasis Area Severity Index scores 
range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, 
thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic 
regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement 
on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% 
to 100% involvement). The total qualitative score (sum of erythema, thickness, and 
scaling scores) is multiplied by the degree of involvement for each anatomic region and 
then multiplied by a constant. These values for each anatomic region are summed to 
yield the PASI score.   
 
3.2.5 Physician Global Assessment (PGA): PGA skin evaluation will be performed  
 
at the Screening visit, Visit 8, Visit 16, Visit 23 Final/Early Termination Visit, and, if 
applicable, the optional 3 month follow-up visit. This assessment is a scale from 0 
(clear) to 5 (severe). It is a global assessment of the subject’s psoriasis based on the 
severity of induration, scaling and erythema. 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 4 of 13 
 
 
3.2.6 Chromameter Assessment: Treated plaques will be evaluated using a chromameter as 
an objective measure of hyperpigmentation and erythema at Screening Visit, Visit 8, 
Visit 16, Visit 23 Final/Early Termination Visit, and, if applicable, the 3 month follow-
up visit.  The chromameter uses the L*a*b* color system. L* measures skin reflectance 
or lightness, a* measures red to green color saturation, b* measures yellow to blue color 
saturation. Hyperpigmentation of treated plaques will be assessed via L*. L* values of 
treated plaques will be compared to L* values of normal, untreated skin. Erythema of 
treated plaques will be assessed via a*. a*  values of treated plaques will be compared to 
a* values of normal, untreated skin. These values will also be compared from visit to 
visit.  
 
3.2.7 Limited Medical Exam: Medical and Dermatological history, demographic 
information, concomitant medications, vital signs, height, weight, and BMI will be 
collected during Visit 1/Screening Visit. 
 
3.2.8 Blood Draw: Blood will be drawn at Visit 1/Screening Visit and at Visit 23 Final/Early 
Termination Visit by venipuncture and will be evaluated for: 
 Serum Inflammatory Markers: (e.g. Levels of CRP, resistin, MPO and S100, etc) 
as quantified via ELISA kits [~10mL blood]. 
 Pro-Inflammatory Monocytes (optional): Populations of monocytes will be 
characterized in the blood and via flow cytometry analysis [~60mL blood]. 
  
3.2.9 Questionnaires: Subjects will be asked to complete two questionnaires. 
 
3.2.5.1 Patient Satisfaction Survey: Patients will be asked to complete a survey, 
scoring their satisfaction with the treatment at Visit 23 Final/Early Termination 
Visit. 
 
3.2.5.2 Nutrition Questionnaire: Patients will be asked to complete a survey about 
their nutritional habits at Visit 1/Screening Visit. 
 
3.2.10 Photographs: Participants will have a photographic record of their skin made 
throughout this study at the discretion of the study doctor to document any changes in 
the psoriasis from the treatment. Photographic records provide objective data on skin 
lesions of persons with skin disease and potential changes that may occur over time in 
the disease. Photography gives us a tool to compare clinical appearance with laboratory 
and research findings. Clinical images will be stored as digital images electronically. In 
the event that a photograph is taken of the patient’s head or any other identifiable 
feature, the patient’s identity may become known. Every precaution will be taken to 
protect the patient’s identity, including blacking-out the patient’s eyes on any 
photographs involving the face.   

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 5 of 13 
 
 
3.3 STUDY VISITS 
 
3.3.1 Visit 1: Screening Visit (estimated time: ~ 90 minutes) 
 Subjects will review the Institutional Review Board (IRB) approved Informed 
Consent Form (ICF) with the study staff. After all study procedures have been 
discussed and all questions have been answered, subjects will affirm participation by 
signing and dating the consent form. 
 Inclusion/exclusion criteria will be reviewed and subject eligibility confirmed. 
 Study staff will review concomitant medications and procedures with each subject. 
 Medical and Dermatological History information will be collected. 
 Vital signs, height, weight and BMI will be collected and recorded. 
 Subjects will have their psoriasis clinically evaluated through PASI scoring and PGA. 
 A chromameter will be used to evaluate pigmentation before treatment.  
 Subjects will have plaque/body photographs taken 
 Subjects will undergo a Sunburn MED Test or Visual MED Test. 
 Subjects will complete a dietary/nutrition questionnaire. 
 Subjects will undergo a pre-treatment blood draw. 
 An optional, pre-treatment punch biopsy may be taken from a psoriasis lesion. 
 
3.3.2 Visit 2 (estimated time: up to 15 minutes) 
**This visit will only be scheduled for patients undergoing the Sunburn MED Test** 
 
 Study staff will review concomitant medications, any AEs since the previous visit, 
and procedures with each subject. 
 Study staff will determine the MED through visual evaluation. 
 Patient may begin first treatment/Visit 3 during this visit. 
 
3.3.3 Treatment Visits (Visits 3-22) (estimated time: up to 1 hour):  
 
*Patients will undergo Treatment twice a week until they reach a PASI 75 
improvement, or until they reach the maximum of 20 total treatments* 
 
 Study staff will review concomitant medications, any AEs since the previous visit, 
and procedures with each subject. 
 Subjects will have their psoriasis clinically evaluated through PASI scoring and PGA 
every four weeks during Visit 8 and Visit 16. 
 During Visit 8 and Visit 16, treated plaques will be evaluated using a chromameter to 
measure hyperpigmentation and erythema that may be caused by the laser. 
 Subjects will have plaque/body photographs throughout this study. 
 Subjects will undergo standard clinical treatment with an Excimer Laser. 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 6 of 13 
 
 
3.3.4 Visit 23: Final Visit/Early Termination Visit [2 days-2 weeks after last treatment] 
(estimated time: up to 1 hour )  
 
 Subjects will have their psoriasis clinically evaluated through PASI scoring and PGA. 
 Treated plaques will be evaluated using a chromameter to measure hyperpigmentation 
and erythema that may be caused by the laser. 
 Subjects may have plaque/body photographs taken. 
 Subjects will undergo a post-treatment blood draw. 
 Optional, post-treatment punch biopsies may be taken from a psoriasis lesion. 
 Subjects will fill out the Patient Satisfaction Survey. 
 
3.3.5 **Optional 3 Month Follow-Up Visit (estimated time: approximately 30 minutes): 
 
 Subjects will have their psoriasis clinically evaluated through PASI scoring and PGA. 
 Treated plaques will be evaluated using a chromameter to measure hyperpigmentation 
and erythema that may be caused by the laser. 
 Subjects may have plaque/body photographs taken. 
 
3.4   Schedule of Events 
 
 
 
Visit 1: 
Screening  
Visit 2 
(Only if 
Sunburn/MED 
was done) 
All Treatment 
Visits  
(Visits 3-22) 
Treatment 
Visit 8 and 
Visit 16 
Visit 23: Final 
Visit/Early 
Termination 
Visit 
**Optional 3 
Month Follow-
Up Visit 
Informed Consent 
X 
 
 
 
 
 
Limited Medical Exam 
X 
 
 
 
 
 
PASI & PGA 
X 
 
 
X 
X 
X 
Photographs* 
X 
X 
X 
X 
X 
X 
Chromameter 
X 
 
 
X 
X 
X 
Blood Draw 
X 
 
 
 
X 
 
Concomitant Med Assessment 
X 
X 
X 
X 
X 
X 
Optional Sunburn/MED Test 
X 
 
 
 
 
 
Optional Sunburn/MED assessment 
 
X 
 
 
 
 
Excimer Laser Treatment 
 
 
X 
X 
 
 
Nutrition Questionnaire 
X 
 
 
 
 
 
Patient Satisfaction Questionnaire 
 
 
 
 
X 
 
Adverse Event Assessment 
X 
X 
X 
X 
X 
X 
Optional Sub-Study: Additional Blood 
X 
 
 
 
X 
 
Optional Sub-Study: Punch Biopsy 
X 
 
 
 
X 
 
*Photographs will be taken throughout this study at the discretion of the study doctor to document any changes in 
the psoriasis from the laser treatment. 
 
 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 7 of 13 
 
 
4. RISKS AND DISCOMFORTS AND HOW MINIMIZED 
 
4.1. Sunburn Test/Minimum Erythema Dose (MED) Testing: A sunburn reaction may result 
from the MED testing. The degree of sunburn that the participant experiences should be light 
to moderate redness (sometimes no redness occurs).  It may result in some tenderness and 
possibly some mild dryness and itching and may change into a tan color, with the degree of 
darkness and the time it takes to fade being dependent upon the light dose and participant skin 
type.  In the most extreme circumstance, to achieve a completely even color of light-exposed 
and adjacent unexposed skin can take over one year, and in most cases, will result in no long-
term effects from this type of exposure. Some sunburns will not be visible, so the area will be 
marked with a black pen to facilitate evaluation. 
 
4.2. Excimer Laser Irradiation: Similar to a sunburn, there could be redness, scaling, 
occasionally blistering of the skin lesion treated. These are considered expected reactions to 
the ultraviolet light. As this is a therapeutic, clinical intervention that is known to reduce the 
inflammation in psoriasis, the benefits outweigh the risks and discomforts. Long-term risks of 
UVB Excimer laser have not been reported in the literature.  
 
4.3. Chromameter Assessment: The chromameter poses minimal risk, as this is a non-invasive 
instrument that is used to measure pigmentation and redness. 
 
4.4. Optional Punch Biopsies: Punch biopsies will be up to 8mm in diameter. Lidocaine, which is 
used to numb the skin prior to biopsy, may cause a tingling or burning sensation when injected 
into the skin.  Potential risks of the biopsy include bleeding or oozing from the biopsy wound, 
discomfort at the site, or infection. One to two sutures will be utilized to close the biopsy site. 
These will be removed 14 days after the biopsy occurs. Suture removal is generally painless, 
but may involve a scant amount of bleeding and some pinching or pulling of the skin. The 
biopsy site will heal with a small, flat scar, which may be red for several months. The scar may 
be lighter or darker than the surrounding area. 
 
4.5. Blood Draw: The risks of simple blood drawing may commonly include the occurrence of 
discomfort and/or bruise at the site of the puncture and, less commonly, the formation of a 
small clot, swelling of the vein, or bleeding from the puncture site. 
 
4.6. Questionnaires: There are no known risks to filling out questionnaires. However, in rare 
instances some participants may feel uncomfortable with answering or applying responses to 
some questions. 
 
4.7. Photographs: There are no known risks to taking photographs. In the event a photograph is 
taken of the face or any other identifiable feature, the patient’s identity may be known. Every 
precaution will be taken to protect the patient’s identity. In the event a photograph is taken of 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 8 of 13 
 
 
the patient’s head or face, the patient’s eyes will be blacked out. 
 
5. COMPENSATION FOR INJURIES 
 
Every effort to avoid side-effects of participating in this research study will be made, but there can 
be no guarantee that study subjects will not experience some physical damage. As there is no 
automatic compensation available for physical injury for a research study, study subjects will not 
be automatically reimbursed for the costs of time lost from work or the costs of extra hospital days, 
doctor’s fees, and medicine. 
 
6. BENEFITS TO SUBJECT 
 
No direct benefit can be guaranteed as a result of participation in this research study, however, 
because UVB Excimer laser is an established therapy for psoriasis, it is anticipated that some 
participants may see an improvement of their disease. Participation in this study will help aid in the 
understanding of Excimer lasers and the effects they have on serum inflammatory markers in the 
body. 
 
7. COSTS TO THE SUBJECT 
 
There is no cost to the participant for research-specific procedures. Standard of care procedures 
will be billed to the subject’s insurance. 
 
8. ALTERNATIVES TO PARTICIPATION 
 
Alternative treatments available to patients who decide not to participate or who may withdraw 
early from the study are: 
 Topical creams/ointments 
 Methotrexate 
 Oral retinoids 
 Cyclosporine   
 Full body narrowband UVB 
 Biologics 
 
9. WITHDRAWAL FROM STUDY PARTICIPATION 
 
The participants are entitled to withdraw from the study at any time and for whatever reason 
without this having an effect on their access to the treatment via the investigator. 
 
 
 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 9 of 13 
 
 
10. PAYMENT TO THE SUBJECTS (REIMBURSEMENT AND INCENTIVES) 
 
The participant will be compensated for study parking costs (if any); parking validated for study-
related visits. Subjects will be compensated $50 at the screening visit and $50 at the final visit to 
cover study-related procedures. All Excimer laser treatment visits will be billable to the patient’s 
insurance company, per standard of care. Participants to choose to participate in the optional sub-
study will receive $20 for each additional blood draw and $25 for each punch biopsy. 
 
11. PLAN FOR OBTAINING INFORMED CONSENT (INFORMED CONSENT PROCESS) 
 
Potential subjects recruited for study participation will be seen by a member of the study staff in a 
private exam room for the formal consent process. 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. 
 
12. PROVISIONS FOR SUBJECTS FROM VULNERABLE POPULATIONS 
 
No special subject populations are targeted for inclusion in this protocol however if subjects from 
vulnerable populations noted below are eligible, additional procedures will be followed.  
 
In the event that an illiterate person who understands English presents themselves as a potential 
study participant and they meet all of the inclusion/exclusion criteria, the consent form will be read 
to that individual in the presence of a witness. The study participant will sign the consent document 
by “making their mark” in the signature space; the witness must also sign and date the consent 
form, noting that the informed consent process has taken place. 
 
House staff and students, medical students on a clerkship, and employees of Case Western Reserve 
University (CWRU) or UHC are not excluded from the study, but their participation will be 
entirely voluntary. Their scholastic or employment evaluations will be conducted by a rater 
uninvolved with, and most likely totally unaware of, the study.  Members of the study team are not 
eligible to participate in this study as a subject.  Subject participation is kept confidential by the 
entire study team, and will not be divulged to supervisors, evaluators, or others, unless under the 
unlikely condition where it becomes medically necessary information, with the subject's consent. 
 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 10 of 13 
 
 
13. SUBJECT PRIVACY AND DATA CONFIDENTIALITY 
 
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 blood samples. Each class of data will be 
handled in the following manner: 
 
13.1  
Patient Records and Consent Forms: 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. 
 
Patient records will be created and stored electronically on both the secure and encrypted 
University Hospitals server and the secure REDCap© server. REDCap serves as the 
main computerized data management system for this study.  
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. 
 
13.2 
Blood Samples: Study personnel will acquire the specimen from each patient via 
needlestick, de-identify the specimen using a code specific for this trial before sending it 
to the lab for processing. 
  
13.3 
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. 
  
13.4 
Data Transfer/Transmission: Research data will be sent to Pingfu Fu, PhD, 
Biostatistical Core, CWRU after finishing the clinical trial: however, all of 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 authorized representatives of the Institutional Review Board or other 
federal regulatory officials responsible for oversight of human subject protection. Any data 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 11 of 13 
 
 
linking participants to their sample will be de-identified. 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. 
 
14. DATA ANALYSIS PLAN 
 
14.1  Clinical Outcome: Clinical evaluation through PASI scoring and PGA will be performed, 
supported by photographic documentation. Percent change in PASI and number of 
treatments to obtain PASI 75 improvement will be calculated for each patient and results 
summarized as descriptive statistics using means and standard deviations. 
 
14.2  Serum inflammatory markers: Levels of inflammatory markers in the serum e.g. CRP, 
resistin, MPO and S100. will be quantified pre and post treatment via ELISA kits and 
correlated with PASI score, total number of treatments received, BMI and nutrition data, 
using multivariate regression analyses. 
 
14.3  Optional flow cytometry analysis: Populations of monocytes will be characterized in the 
blood and response to excimer laser expressed in improvement in PASI scores will be 
correlated with levels of specific pro-inflammatory monocytes using Pearson correlation 
coefficient. Level of pro-inflammatory monocytes will also be correlated with levels of 
CRP, resistin, MPO, S100. 
 
14.4  Chromameter Assessment: Hyperpigmentation of treated plaques will be assessed via L*. 
L* values of treated plaques will be compared to L* values of normal, untreated skin. 
Erythema of treated plaques will be assessed via a*. a*  values of treated plaques will be 
compared to a* values of normal, untreated skin. These values will also be compared from 
visit to visit. They will also be correlated with response to treatment.  
  
14.5  Patient Satisfaction Questionnaire: Each item in the survey will be scored from 1-5. 
Scores will be summarized and descriptive statistics will be used. Satisfaction scores will 
also be correlated with PASI improvement.  
 
15. DATA AND SAFETY MONITORING PLAN 
 
15.1 Procedures for analysis and interpretation of data 
 
The PI or co-investigator holds meetings with the staff performing both the clinical and 
laboratory based assessments. These meetings occur on a minimum of a monthly basis, but 

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 12 of 13 
 
 
often occur more frequently. These meetings are held for two primary functions: 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 designated medical study coordinator. 
 
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: 
 
Score Description 
0 
No Adverse Event or within normal limits or not clinically 
significant 
1 
Mild AE did not require treatment 
2 
Moderate AE resolved with treatment 
3 
Severe AE resulted in inability to carry on normal activities and 
required medical attention 
4 
Life threatening or disabling AE 
5  
Fatal AE 
 
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. 
 
C. Implementation of the data and safety monitoring plan: 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), with the exception of 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.   

University Hospitals Case Medical Center 
Department of Dermatology 
Protocol 
 
Protocol Title: Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients with 
Psoriasis 
Principal Investigator: Margaret Bobonich, NP 
Co-Principal Investigator: Elma D. Baron, MD 
 
06-13-33 Protocol v1.2  02.27.2014 
Page 13 of 13 
 
 
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. 
 
16.  PLANS FOR THE SUBJECTS AT THE END OF THE PROTOCOL 
 
At the last visit, patients will be advised that lesions that do not demonstrate improvement should 
be treated using other established therapies (e.g.topical steroids, retinoids, phototherapy, etc), and 
appropriate referrals will be made. 
 
16. REFERENCES 
  
1) Parisi R et al. Global Epidemiology of Psoriasis: A Systemic Review of Incidence and 
Prevalence. J Invest Dermatol 2013; 133(2): 377-85.  
2) Nakajima et al. Clear association between serum levels of adipokines and T-helper 17-related 
cytokines in patients with psoriasis. Clin exp Dermatol 2013; 38(1):66-70.  
3) Kawashima et al. Phototherapy reduces serum resistin levels in psoriasis patients. Photoderm 
Photoimmunol Photomed 2011, 27(3);152-55. 
4) Mudigonda et al. A review of targeted ultraviolet B phototherapy of psoriasis. J Am Acad   
Dermatol 2012, 66; 664-72.   
5) Taibjee et al. Controlled study of excimer and pulsed dye lasers in the treatment of psoriasis. 
Br J Dermatol 2005, 153; 960-966.