Conditions: Cutaneous Lupus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: yes

Brief summary:
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.

Detailed description:

Arms:
arm 1: 532nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. arm 2: 1064nm laser is applied to the patient's lesion in-clinic in addition to a topical corticosteroid. arm 3: Topical corticosteroid is applied to the patient's lesion.

Interventions: intervention 1: 532nm laser intervention 2: 1064nm laser intervention 3: Topical corticosteroid
Intervention descriptions: intervention 1: 532nm laser will be used to treat the lesion in this study arm. intervention 2: 1064nm laser will be used to treat the lesion in this study arm. intervention 3: The topical corticosteroid will be used to treat the lesion in this study arm.

Protocol document:
Prot_SAP_002.pdf: 
 
Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of 
Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone 
 
 
NCT03639857 
 
Date: May 22nd, 2019 


 
1) Protocol Title 
A Comparative Study of the Efficacy of 532nm Laser and 1064 nm laser as 
Adjuncts to Topical Corticosteroids in the Treatment of Cutaneous Lupus 
Erythematosus Versus Topical Corticosteroids Alone 
2) Principal Investigator 
David Weinstein M.D., UCF College of Medicine, UCF Health 
Co-Principal Investigator: Naveed Sami M.D., UCF Health 
Co-Principal Investigator: Samantha Prabakaran B.S., UCF College of Medicine 
Co-Principal Investigator: Amelia Winter B.A., UCF College of Medicine 
Co-Principal Investigator: Adam Foley, B.S., UCF College of Medicine 
Co-Principal Investigator: Kyle Sommerfield, B.S., UCF College of Medicine 
Sub-Investigator: Sun Kim, B.A., UCF College of Medicine 
Sub-Investigator: Rachel Diem-Trang Truong, B.A., UCF College of Medicine 
 
3) Objectives 
 
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) 
laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as 
adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus 
versus topical corticosteroids alone. 
 
Our hypothesis is that adding laser treatment to standard of care will result in quicker 
resolution of lesions of cutaneous lupus. Furthermore we hypothesize that the 532nm 
laser will be more effective than the 1064nm laser. 
 
The results of the study will either be submitted for publication in a journal or presented 
at a conference.  Data from this study also could be used for further studies to clarify the 
ideal laser settings for use in cutaneous lupus. 
 
4) Background 
 
Systemic Lupus Erythematous (SLE) is an autoimmune disorder characterized by the 
production of autoantibodies that can affect almost every organ in the human body. Most 
commonly there is a skin and musculoskeletal involvement, but there also can be 
hematologic, renal, and central nervous system manifestations as well.1 
 
It is estimated that 80% of people with SLE have skin involvement referred to as 
Cutaneous Lupus Erythematous (CLE).  CLE can develop independently of SLE and is 
more prevalent than SLE alone. Women ages 20 to 50 years old are most commonly 
affected by CLE although males and other ages can be affected as well. 2 


 
CLE is typically categorized as acute (ACLE), subacute CLE (SCLE), and chronic 
(CCLE). ACLE develops in nearly one half of patients with SLE, but most or all people 
with ACLE have SLE. Also known as "malar rash" or "butterfly rash”, ACLE is 
characterized by erythema distributed over the cheeks and nasal bridge of the face. 1 
SCLE is less common but may appear as round, scaly lesions with central clearing. 
Discoid Lupus Erythematosus (DLE), a form of CCLE, is one of the most common forms 
of cutaneous lupus and can appear as erythematous and hyper- and hypopigmented 
lesions with telangiectasias. Frequently these lesions lead to scarring and can be 
permanently disfiguring.  
 
First line management of CLE involves photo protection along with topical 
corticosteroids and possibly systemic agents. Other treatments include intralesional 
steroids and/or topical calcineurin inhibitors.1 Both topical and systemic medications 
carry a wide range of adverse and toxic effects.3–5 
 
Though not well-known, laser therapy has been shown to be effective in the treatment of 
cutaneous lupus.6–8 Many providers may be wary of using lasers on these patients given 
the ability of ultraviolet light to exacerbate or flare SLE.9,10 It is believed that by targeting 
the superficial vasculature the lasers are able to attenuate the inflammatory response seen 
in the skin.11 
 
The 585 nm, 595 nm and 1064 nm wavelength lasers have all been shown to be effective 
in the treatments of cutaneous lupus.6–8,12 Given their ability to target vasculature, these 
lasers are currently used to treat vascular lesions and inflammatory conditions such as 
port wine stains, telangiectasias, hemangiomas, rosacea, and scars.13,14 
 
Lasers utilizing the 532nm wavelength also have been shown to treat the same vascular 
and inflammatory conditions as the above mentioned wavelengths. This is due to the fact 
that the 532nm laser targets the same chromophore of oxyhemoglobin.15,16  
 
Therefore, given that the 532nm has very similar properties and same mechanism of 
action as other vascular lasers shown to be effective at treating cutaneous lupus it would 
be reasonable to consider that the 532nm laser could be utilized to treat cutaneous lupus 
as well. 17 
 
However, since the 532 nm should be used with caution in darker skin people and SLE is 
2 to 4 times higher in African-American women than Caucasian women, utilizing only 
the 532nm would limit the applicability of the proposed study.14,18  
 
Therefore, we are proposing investigating the use a 1064nm laser as well in treating 
cutaneous lupus as this wavelength is safe on people of all skin types.9 The 1064nm laser 
has previously been shown to be effective in cutaneous lupus though further studies are 
needed to confirm the preliminary findings and better characterize the effectiveness. 11 
 
When compared to available topical and systemic therapies, laser therapy generally has 
been shown to have minimal side effects. The most common adverse effect is bruising 


 
but that usually clears within 10 days. Other adverse effects include temporary 
dyspigmentation and very rarely scarring, vesiculation, and crusting that usually fade 
within a few weeks.14  
 
The 532nm laser and 1064nm wavelength lasers are currently being used in an off-label 
manner by Dr. David Weinstein of UCF Health to treat patients with cutaneous lupus 
with excellent clinical results. As there is limited data on the use of the 532nm and 
1064nm lasers for cutaneous lupus, we hope to quantify the magnitude of the results in a 
prospective manner. 
 
As lasers with these wavelengths are present in many dermatology practices, we hope 
that data from this study will educate and encourage more providers to use lasers, such as 
the one in this study, to benefit their patients with cutaneous lupus. 
 
 
5) Setting of the Human Research 
• The human research will be conducted at UCF Health Clinic at 9975 Tavistock 
Lakes Blvd., Orlando, FL 32827.  
• UCF College of Medicine’s resources will be used during data analysis 
• We have obtained permission and approval from UCF Health medical director Dr. 
Maria Cannarozzi 
 
6) Resources available to conduct the Human Research 
• Participants will be recruited through the UCF Health Clinic, Lupus Foundation 
of Florida, and the Central Florida Society of Dermatology. This represents a 
large pool of potential participants from which to recruit. 
• The study’s small sample size (N=25) makes it likely that the required number of 
participants will be recruited in less than 12 months. 
• Research will be conducted during Dr. Weinstein’s clinical time. Dr. Weinstein, a 
UCF Health board-certified physician, will perform the screening of eligible 
participants. Dr. Weinstein has significant prior experience conducting research, 
knowledge of the regulations and customs at UCF Health, and works regularly 
with patients performing laser treatments. Off-label laser treatments currently 
performed are fractionated CO2 laser for morphea, 1064nm and 532nm laser for 
sarcoidosis and acne, and 532nm laser for cutaneous lupus among others. 
Experience has been presented at invited talks/grand rounds. All treatments will 
be administered by Dr. Weinstein.  
• All individuals assisting in the research study will be provided a copy of the 
approved IRB study protocol and given the opportunity to meet with the principal 
investigator before recruitment begins. The principal investigator, Dr. Weinstein, 
will be responsible for informing all research staff of their research-related duties 
during a personal meeting or via phone or email. The contact information of the 
principal investigator and co-principal investigators will be distributed to all 
research staff and the participants. 


 
• The study will be will be conducted at the UCF Health Clinic, see section 5 
(Setting of the Human Research). Extramural funding will be sought from various 
organizations or industry.  
• The chances of a research related injury are extremely rare. However treatment 
for research related minor injuries will be made available at no cost by Dr. 
Weinstein if possible. For injuries that cannot be treated by Dr. Weinstein the 
participant will be referred elsewhere. Costs associated with this treatment may be 
billed to the participant’s insurance company. Costs not covered by participant’s 
insurance company will be the participant’s responsibility. 
• The study has been approved by the UCF Health Privacy Officer. 
 
7) Study Design 
 
a) Recruitment Methods 
• For this study, we will recruit 25 adult male and female volunteers age 18 years 
and older. This number was calculated with the Univeristy of California San 
Francisco (UCSF) Clinical and Translational Science Institute Sample Size 
Calculator with a power of 0.8, effect size of 0.25, and alpha of 0.05.  
• Participants with a diagnosis of cutaneous lupus will be recruited from the UCF 
Health Clinic during a patient’s visit (medical records will not be searched for 
patients with a diagnosis of cutaneous lupus) and through advertising on the UCF 
Health website and within the UCF Health clinic. Potential participants also will 
be identified through email by the Lupus Foundation of Florida to its membership 
and the Central Florida Society for Dermatology. (See attached “Advertisement”). 
• Dr. Weinstein and Dr. Sami will rely on prior labs, pathology reports, and 
physical examination to determine if the participant has cutaneous lupus.  
• If interested in participating, participants will contact the primary or co-
investigator, who will provide instructions on how to enroll in the study.  
• The investigator will describe the details of the study and answer any questions 
the participant may have about the study. Participants will be given an informed 
consent about the study and the primary investigator’s contact information. Those 
participants who express interest in the study will be required to sign the HIPAA 
Authorization form (attached), Informed Consent form (attached) to ensure that 
there is no coercion in the study. Each of these will be signed both by the 
participant and by Dr. Weinstein.  
 
 
b) Participant Compensation 
 
• The study participants will not be receiving any compensation for their 
participation in the study. 
 
c) Inclusion and Exclusion Criteria 
 
• For this study, we will recruit approximately 25 male and female volunteers ages 
18 and older. All volunteers will be asked to give informed consent and sign a 


 
HIPAA authorization before participation in the experiment. Participants will be 
screened in person before the research takes place. Participants will be screened 
and evaluated in the clinic to verify diagnosis through history, physical findings, 
health records, and previous labs. Participants who fit the diagnosis of cutaneous 
lupus will be asked whether they wish to participate in the study during the patient 
visit. 
 
• Inclusion Criteria:  
o Male or female adult 18 years of age or older 
o Ability to rate level of pain 
o Ability to rate visual satisfaction 
o At least 2 active lesions of CLE 
 
• Exclusion Criteria:  
o New or change in systemic medication for cutaneous lupus in past 6 
months 
o Allergy to triamcinolone or betamethasone dipropionate cream 
o Pregnancy 
o Currently a prisoner 
o Unable to read and speak English since consent will only be available in 
English 
 
d) Study Endpoints 
• Primary endpoints: Participation in the study will end after the third visit. 
• Primary safety endpoints: none 
• Secondary safety endpoints:  
o Adverse reaction to the laser treatment such as blister, ulceration, and 
scarring. 
o Adverse reaction to the topical steroid such as atrophy, telangiectasias or 
striae. 
o Intolerance to pain of laser procedure. 
 
e) Study Timelines 
• Each participant will be in the study for a maximum of 8 weeks. Participants will 
receive 2 laser treatments. The laser treatments will be spaced 4 weeks apart 
between visit 1 and visit 2. Finally, 4 weeks after visit 2, the participants will be 
followed up during visit 3.  
 
• The duration expected for all study participants to be recruited is estimated to be 
28 weeks.   
 
• The study will end when the last participant has completed the 2 laser treatments 
and follow up. The goal is to conclude the data collection by October 31, 2018 
and complete primary analysis by December 31, 2018. 
 


 
 
f) Procedures involved in the Human Research. 
• This study will be a randomized prospective study. All study lesions will receive 
topical treatment. One lesion will only receive topical treatment to serve as a 
control, and up to 2 others will also receive laser treatment in addition to the 
topical treatment.  
 
• Standard of care treatment will be a topical corticosteroid as follows: 
o Discoid lupus lesions: Betamethasone dipropionate augmented 0.05% 
cream twice a day as needed 
o Non-discoid cutaneous lupus lesions: Triamcinolone acetonide 0.1% 
cream twice a day as needed 
 
• Laser treatment will be randomized based upon the participant Fitzpatrick Skin 
Type as follows: 
o Fitzpatrick Skin Types I – III: 
§ Treatment lesion will be treated with 532nm laser or 1064nm laser 
§ 50:50 randomization for laser used (determined by coin flip) 
§ If the participants have an additional lesion then this will be treated 
with the laser not used for the treatment lesion  
o Fitzpatrick Skin Types IV - VI 
§ Treatment lesion will only be treated with the 1064nm laser. This 
is because the 532 nm wavelength is absorbed easily by melanin 
and thus can cause skin pigmentation abnormalities when used 
with darker skin participants.  
 
• Laser treatment system details and parameters: 
o The Excel V laser system manufactured by Cutera (Brisbane, CA) will be 
used to administer all laser treatments. This laser has the capability of 
emitting both 532nm and 1064nm wavelengths. 
o Treatments with the 532nm wavelength will utilize parameters in the 
following ranges: 
§ Spot size: 1-12mm 
§ Fluence: 5-12 J/cm2 
§ Pulse Duration: 3-15ms 
§ Temperature: 5-10°C 
o Treatments with the 51064nm wavelength will utilize parameters in the 
following ranges: 
§ Spot size: 1-12mm 
§ Fluence: 10-60 J/cm2 
§ Pulse Duration: 10-60ms 
§ Temperature: 5-10°C 
 
• Note: If the lesions are ill-defined such as those of ACLE and SCLE then a lesion 
will be defined as a 2cm2 within the involved area.  
 


 
 
 
 
 
25
Participants
Skin
Type
I
- III
Treatment
Lesion
532nm
laser
or
1064nm
laser
(50:50
randomization)
AdditionalTreatment
Lesion
(if
available)
532nm
laser
or
1064nm
laser
(whichever
laser
not
used
on
Treatment
Lesion)
Control
Lesion
Skin
Type
IV
- VI
Treatment
Lesion
1064nm
laser
Control
Lesion
Screening


 
• Timeline: 
Pre-Week 0: Screening Visit 
o Screening: participant will be screened for inclusion and exclusion criteria, 
including urine pregnancy test if necessary. 
Week 0: Visit 1 
o Baseline lesion assessment, lesion selection, randomization and treatment 1 
will occur. 
Week 4: Visit 2 
o Follow up lesion assessment 
o Treatment 2 
Week 8: Visit 3 
o Final lesion assessment 
 
• Lesion assessment: 
Limited CLASI: 
The classification of cutaneous lupus will be recorded for each participant. 
A  ‘‘limited’’ CLASI scoring system will be used, subdivided into an ‘‘active’’ and 
‘‘damage’’ components.  
The limited active CLASI for a lesion will include the following: 
o Erythema (ranging from 0 = absent to 3 = dark red/purple) 
o Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic) 
o The addition of these scores result in a total limited active CLASI score of the 
studied lesion, ranging from 0 to 5. 
The limited damage CLASI for a lesion will include the following: 
o Dyspigmentation (0 = absent or 1 = present) 
o Scarring/Atrophy/Panniculitis (ranging from 0 = absent to 2 = severely 
atrophic scarring or panniculitis).  
o The addition of these scores result in a maximum damage score of 3. 
The total limited CLASI reflects the sum of both active and damage CLASI, resulting 
in a score ranging from 0 to 8.  
 
Photographs will be taken of all study lesions during every assessment. 
 
All participants will evaluated by Dr. Weinstein at baseline and at subsequent visits. 
All participants will be evaluated via photograph by Dr. Sami at baseline and 
subsequent visits. Dr. Sami will be blinded to the treatment type so as to be an 
independent observer. He will utilize the “Independent Observer Survey” to 
document his assessments.  
 
Visual Satisfaction of Appearance: 
In addition participants will rate the cosmetic results on a visual analog scale (VAS). 
A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will 
represent cosmetically excellent result. 
 
• Adverse Effects: 


 
Pain: After each treatment pain will be recorded on VAS. A score of 0 will represent 
absence of pain and 10 will represent maximal pain. 
 
Other adverse effects that will be monitored for: 
o Hyperpigmentation 
o Hypopigmentation 
o Crusting 
o Vesiculation 
o Scarring 
 
• Risk Management: 
Participants will be directly observed for any adverse effects during treatment. The 
chances of a research related injury are extremely rare. However treatment for 
research related minor injuries will be made available at no cost by Dr. Weinstein if 
possible. For injuries that cannot be treated by Dr. Weinstein the participant will be 
referred elsewhere. Costs associated with this treatment may be billed to the 
participant’s insurance company. Costs not covered by participant’s insurance 
company will be the participant’s responsibility. 
 
Participants will not be misled in anyway about procedures/activities being performed 
 
Research will be conducted during Dr. Weinstein’s clinical time. 
 
The duration of research should take approximately 12 months. The research study will 
begin recruitment directly after IRB approval in hopes of being finished by December of 
2018. 
 
No audio or video recordings will be used in this study. However photographs will be 
taken of the lesions for assessment purposes. Though the photos will not contain any 
identifiers, participants are potentially identifiable from the photos and thus they will be 
stored in the HIPAA-compliant electronic health record (EHR) of UCF Health. 
 
A study survey document (see attached “Survey” and “Independent Observer Survey”) 
will be used to record the following: 
o Age 
o Gender 
o Pregnancy Status 
o Fitzpatrick Skin Type 
o Past Medical History 
o Medications 
o Allergies 
o Lesion locations 
o Lesion type 
o Lesion treatment 
o Limited CLASI 
o Patient cosmetic assessment 


 
o Whether patient would recommend treatment 
o Pain and adverse effect assessment 
Note: the above information will be collected from the medical records and during the 
study visits. 
 
Medical records in the HIPAA-compliant EHR at UCF Health will be used to obtain the 
following data: 
o Age 
o Gender 
o Past Medical History 
o Medications 
o Medication Allergies 
o Social History 
o Photographs 
o Laboratory Results 
 
Student/school records are not to be used. 
 
g) Data and specimen management 
There will be no specimen collection, and thus there will be no management of physical 
specimens. 
 
If a participant withdraws from the study, the reason for the withdrawal will be noted but 
data collected up to that point will be used.  
 
All data will be collected on the survey documents (see attached documents “Survey” and 
“Independent Observer Survey”). These survey documents will be stored in regulatory 
binder in a locked drawer in locked room at UCF Health. This will only be accessible 
only to the principal investigator and co-principal investigators. These survey documents 
will then be used to transfer the data to the REDCap database, afterwards they will be 
disposed of in HIPAA-compliant shred bin. 
 
Photographs of study lesions will be stored directly in the EHR. 
 
The data will be analyzed for significant differences with aid of a statistician. A 
significance level of 0.05 will be used for statistical hypothesis testing. The results of the 
data analysis will be graphed for each parameter.  
 
h) Provisions to monitor the data for the safety of participants  
 
The principal investigator and statistician will periodically review cumulative CLASI 
scores and adverse effect data every 10 patients. 
 
If the change in the active CLASI score for the treatment lesion is 3 points higher than 
the change in the active CLASI score for control lesions with p < 0.05 then the study will 
be suspended immediately. 


 
 
If participants have ulceration or scarring attributable to the laser treatment as an adverse 
effect with p <0.05 then the study will be suspended immediately. 
 
i) Withdrawal of participants 
 
Participants will be withdrawn from the research without their consent if they become 
intolerant to the laser treatments and/or the investigators determine that they are too 
nervous, anxious to continue. 
 
Participants may terminate their participation in the research study at any time by 
informing a member of the research team. If the participant declines any further laser 
treatments he or she may still participate in the study with follow up assessments being 
completed. 
 
If participants miss study Visit 2, the researchers will attempt to reach the participant to 
reschedule. If the participant is unable to reschedule within 2 weeks of the missed 
appointment then the participant will forego the 2nd treatment and attempted to be 
scheduled for Visit 3. 
 
If participants miss study Visit 3, the researchers will attempt to reach the participant to 
reschedule. If the participant is unable to reschedule within 6 weeks of the missed 
appointment then the participant will be withdrawn from the study. Further data 
collection will not be continued. 
 
8) Risks to participants 
Laser treatment association risks15,16,19: 
Risks: >50% 
• Pain/Discomfort – Additionally sharp burning/stinging pain can occasionally be felt.  
 
Risks: <10% 
• Redness/Swelling/Bruising – Short term redness (erythema) or swelling (edema) of 
the treated area is common and may occur. There also may be some bruising. 
• Skin Color Changes – During the healing process, there is a possibility that the 
treated area may become either lighter (hypopigmentation) or darker 
(hyperpigmentation) in color compared to the surrounding skin.  This is usually 
temporary, but, on a rare occasion, it may be permanent. 
• Itching/Burning/Dry skin – Treatment may results in itching, burning, and/or dry skin 
during the recovery period.  
• Red Rash/Bumps – Red rash/bumps may appear after treatment.  This resolves with 
time.  
• Acne flare-up or cold sore – this may occur after treatment.  
 
Risks: <1% 


 
• Wounds – Treatment can result in burning, blistering, scabbing, or bleeding of the 
treated areas.  
• Infection – Infection is a possibility whenever the skin surface is disrupted, although 
proper self-wound care should prevent this.  
• Scarring – Scarring is a rare occurrence, but it is a possibility when/if the skin surface 
is disrupted.  To minimize the chances of scarring, it is important that participants 
follow all post-treatment instructions provided by the research staff. (see attached pre- 
and post-treatment instructions) 
 
Other risks: 
• Sun Exposure / Tanning Beds/ Artificial Tanning - May increase risk of side effects 
and adverse events and must be avoided.  
• Eye Exposure – Protective eyewear (shields or goggles) will be provided to the 
participant during the treatment.  Failure to wear protective eyewear during the entire 
treatment may cause severe and permanent eye damage. 
• Lack of improvement (procedure may not work) or exacerbation of cutaneous lupus.  
 
There is unknown risk to the an embryo or fetus should the participant be pregnant as 
none of the clinical trials with the laser were performed on pregnant women. 
There are no risks to an embryo or fetus should the participant become pregnant. 
There is no risk to non-participants. 
 
Topical corticosteroid associated risks20: 
• Atrophy  
• Telangiectasias 
• Striae 
• Perioral dermatitis 
• Hypertrichosis 
• Folliculitis 
• Note: All risks are approximately <5%21 
 
9) Potential direct benefits to participants 
 
While there are no guarantees that participants will receive any benefits from their 
participation in this study, potential benefits include quicker improvement of cutaneous 
lupus lesions less scarring than standard of care, and topical treatment at no cost for 
cutaneous lupus for duration of study participation. 
 
10) Provisions to protect the privacy interests of participants 
 
Participants will be seen and treated in the same manner as patients in the UCF Health 
clinic. In the clinic, efforts are made to protect patients’ privacy whenever possible as per 
HIPAA guidelines.  
 
11) Provisions to maintain the confidentiality of data 
 


 
Data will be stored in the secure HIPAA-compliant database called REDCap. 
Unique identifiers will be created using sequential numbers (i.e. 1, 2, 4 etc.). 
 
No data collection instrument in REDCap will contain identifying information 
 
A screening and enrollment log (see attached document “Screening and Enrollment 
Log”) will be stored in a regulatory binder in a locked drawer in a locked room at UCF 
Health. Only Dr. David Weinstein will have access to this locked drawer. 
 
A subject ID assignment list (see attached document “Subject ID Assignment List”) that 
links the subject name and contact information with their unique identifier will be stored 
in a separate folder in locked drawer in a locked room at UCF Health. Only Dr. David 
Weinstein will have access to this locked drawer. 
 
Identifying information such as the “Subject ID Assignment List” will only be accessed 
by the PI and co-PIs for initial entry. It is possible the identifiable information may be 
referenced if questionable data are detected during data analysis (e.g.: number out of 
range, missing data). 
 
The “Screening and Enrollment Log” and the “Subject ID assignment List” will both be 
disposed of in a HIPAA-compliant shred bin at the completion of the study. 
 
Informed consents and HIPAA authorizations will be stored in locked drawer in a locked 
room at UCF Health and kept for a minimum of six years after the conclusion of the 
study (per UCF data retention policies.) 
 
Only de-identified data will be used and exported for analysis.  
 
De-identified data will be stored for a minimum of five years after the conclusion of the 
study (per UCF data retention policies).  
 
 
 
12) Medical care and compensation for injury 
The chances of a research related injury are extremely rare. However treatment 
for research related minor injuries will be made available at no cost by Dr. 
Weinstein if possible. For injuries that cannot be treated by Dr. Weinstein the 
participant will be referred elsewhere. Costs associated with this treatment may be 
billed to the participant’s insurance company. Costs not covered by participant’s 
insurance company will be the participant’s responsibility. 
 
13) Cost to participants 
The only costs to the participant are his or her time (approximately 1.5 hours) and 
transportation costs (gas, tolls, etc.). There are no other expected costs that 


 
subjects will incur as a result of participating in the study.  For cost of research 
related injury please see section 12). 
 
14) Consent process 
Participants will be given the option of picking up the consent prior to enrolling to 
discuss with their primary care physician, significant other, etc., to help minimize the 
possibility of coercion or undue influence. 
 
 
On the day of enrollment, participants will meet with the PI in one of the clinic rooms 
and be given an informed consent form. HIPAA authorization form and the PI’s contact 
information. The PI will describe the details of the study and answer any questions the 
participant may have about the study. Afterwards, the PI will thoroughly explain every 
section of the informed consent to the participant and give the participant as much time to 
review the informed consent as needed. Participants will be given the opportunity to 
voice questions or concerns to the PI or co-principal investigators following their review 
of the informed consent. Those participants who wish to participate in the study will then 
be asked to sign the informed consent. The informed consent document will be signed 
both by the participant and the PI.  
 
After signing the Informed Consent, Visit 1 will take place and potential participants will 
be screened in person at UCF Health to determine if they meet the inclusion/exclusion 
criteria for study. 
 
The “SOP: Informed Consent Process for Research (HRP-090)” will be followed. 
 
The written informed consent and other documents will be made available in English 
only. 
 
The Human Research does not involve a waiver or alteration of the consent process. 
 
The Human Research does not involve persons who have not attained the legal age for 
consent to treatment. 
 
The Human Research does not involve adults who may be unable to consent. 
 
 
15) Process to document consent in writing 
 
All participants will be required to complete and sign the informed written consent 
document (see attached) and the HIPAA authorization form (see attached) to ensure that 
there is no coercion in the study. The informed consent and HIPAA authorization forms 
will be signed both by the participant and by the principal investigator.  
 
The informed consent and HIPAA authorization forms will be scanned and uploaded the 
REDCap database. Afterwards they will be disposed of in a HIPAA compliant shred bin. 


 
 
The consent process will be documented in writing 
 
16) Vulnerable populations 
 
We are not recruiting members of a vulnerable populations. The participants are aware of 
their CLE diagnosis and will be informed on the risks and benefits of both laser treatment 
and traditional first line topical treatment.  
 
This study will not use participants that are unable to consent. 
 
This study will not use participants who have not attained the legal age for consent 
 
This study will not use participants who are pregnant 
 
This study will not use participants who are prisoners    
 
17) Drugs or Devices 
 
The following laser will be used in this study: 
Laser model:    
Excel V 
Manufacturer:   
Cutera, Inc.  
 
 
 
3240 Bayshore Blvd. 
 
 
 
Brisbane, California 94005 
 
The laser used in this study is not experimental and is an FDA-approved device which 
will be used in an FDA-approved manner for an off-label indication.  
 
The laser is kept in one of the procedure rooms in clinic which has access restricted by 
key and/or keycard. The key necessary to turn on and use the laser is stored in a lock 
drawer within clinic.  
 
18) Multi-site Human Research 
Not applicable. Research will only be conducted at UCF-affiliated institutions in 
Orlando, FL. 
 
19) Sharing of results with participants 
There are no plans to share results with participants unless requested by the participants. 
 
References 
 
1.  
Okon LG, Werth VP. Cutaneous lupus erythematosus: diagnosis and treatment. 
Best Pract Res Clin Rheumatol [Internet] 2013;27(3):391–404. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/24238695%5Cnhttp://www.pubmedcentral.


 
nih.gov/articlerender.fcgi?artid=PMC3927537 
2.  
Tebbe B, Orfanos CE. Epidemiology and socioeconomic impact of skin disease in 
lupus erythematosus. Lupus 1997;6(2):96–104.  
3.  
Kuhn A, Sticherling M, Bonsmann G. Clinical manifestations of cutaneous lupus 
erythematosus. J Dtsch Dermatol Ges [Internet] 2007;5(12):1124–37. Available 
from: http://www.ncbi.nlm.nih.gov/pubmed/18042093 
4.  
Patel P, Werth V. Cutaneous lupus erythematosus: A review. Dermatol. Clin. 
2002;20(3):373–85.  
5.  
Winkelmann RR, Kim GK, Del Rosso JQ. Treatment of cutaneous lupus 
erythematosus: Review and assessment of treatment benefits based on Oxford 
Centre for Evidence-based Medicine criteria. J. Clin. Aesthet. Dermatol. 
2013;6(1):27–38.  
6.  
Erceg A, Bovenschen HJ, van de Kerkhof PCM, de Jong EMJG, Seyger MMB. 
Efficacy and safety of pulsed dye laser treatment for cutaneous discoid lupus 
erythematosus. J Am Acad Dermatol [Internet] 2009;60(4):626–32. Available 
from: http://dx.doi.org/10.1016/j.jaad.2008.11.904 
7.  
Baniandrés O, Boixeda P, Belmar P, Pérez A. Treatment of lupus erythematosus 
with pulsed dye laser. Lasers Surg Med 2003;32(4):327–30.  
8.  
Park KY, Lee JW, Li K, Seo SJ, Hong CK. Treatment of refractory discoid lupus 
erythematosus using 1,064-nm long-pulse neodymium-doped yttrium aluminum 
garnet laser. Dermatologic Surg 2011;37(7):1055–6.  
9.  
Casciola-Rosen L a, Anhalt G, Rosen  a. Autoantigens targeted in systemic lupus 
erythematosus are clustered in two populations of surface structures on apoptotic 
keratinocytes. J Exp Med 1994;179(4):1317–30.  
10.  
Kochevar IE. Action spectrum and mechanisms of UV radiation-induced injury in 
lupus erythematosus [Internet]. J. Invest. Dermatol. 1985;85(1 Suppl):140s–143s. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/2409182 
11.  
DÍez MTT, Boixeda P, Moreno C, GonzÚlez JA, Zamorano ML, Olasolo PJ. 
Histopathology and immunohistochemistry of cutaneous lupus erythematosus after 
pulsed dye laser treatment. Dermatologic Surg 2011;37(7):971–81.  
12.  
Raulin C, Schmidt C, Hellwig S. Cutaneous lupus erythematosus-treatment with 
pulsed dye laser. Br J Dermatol 1999;141(6):1046–50.  
13.  
Alster TS, Williams CM. Treatment of keloid sternotomy scars with 585 nm 
flashlamp-pumped pulsed-dye laser. Lancet 1995;345(8959):1198–200.  
14.  
Husain Z, Alster TS. The role of lasers and intense pulsed light technology in 
dermatology. Clin. Cosmet. Investig. Dermatol. 2016;9:29–40.  
15.  
Butler EG, McClellan SD, Ross EV. Split treatment of photodamaged skin with 
KTP 532 nm laser with 10 mm handpiece versus IPL: A cheek-to-cheek 
comparison. Lasers Surg Med 2006;38(2):124–8.  
16.  
Kwiek B, Rożalski M, Kowalewski C, Ambroziak M. Retrospective single center 
study of the efficacy of large spot 532 nm laser for the treatment of facial capillary 
malformations in 44 patients with the use of three-dimensional image analysis. 
Lasers Surg Med 2017;49(8):743–9.  
17.  
Sakamoto FH, Avram MM, Anderson RR. Lasers and Other Energy-Based 
Technologies – Principles and Skin Interactions [Internet]. In: Jean L. Bolognia, 
MD, Julie V. Schaffer M and LC, editor. Dermatology. Elsevier; 2018 [cited 2018 


 
Apr 8]. p. 2358–9.Available from: https://www-clinicalkey-
com.ezproxy.med.ucf.edu/service/content/pdf/watermarked/3-s2.0-
B9780702062759001367.pdf?locale=en_US 
18.  
Stojan G, Petri M. Epidemiology of systemic lupus erythematosus: An update. 
Curr Opin Rheumatol 2018;30(2):144–50.  
19.  
Keaney TC, Tanzi E, Alster T. Comparison of 532 nm potassium titanyl phosphate 
laser and 595 nm pulsed dye laser in the treatment of erythematous surgical scars: 
A randomized, controlled, open-label study. Dermatologic Surg 2016;42(1):70–6.  
20.  
Akers WA. Risks of unoccluded topical steroids in clinical trials. Arch Dermatol 
[Internet] 1980;116(7):786–8. Available from: 
https://jamanetwork.com/journals/jamadermatology/article-abstract/541219 
21.  
Marks R. Adverse Side Effects from the Use of Topical Corticosteroids [Internet]. 
In: Topical Corticosteroids. S. Karger AG; [cited 2018 Apr 8]. p. 170–
83.Available from: https://www.karger.com/Article/FullText/419867 
 

ICF_003.pdf: 
 
Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of 
Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone 
 
 
NCT03639857 
 
Date: May 22nd, 2019 


   
1 of 6
A Comparative Study of the Efficacy of 532nm Laser and 1064 nm laser as Adjuncts to Topical 
Corticosteroids in the Treatment of Cutaneous Lupus Erythematosus Versus Topical Corticosteroids 
Alone
Informed Consent 
Principal Investigator:  
David Weinstein M.D., Assistant Professor of Dermatology
Co-Investigators:  
Naveed Sami M.D., Professor of Dermatology
Amelia Winter, B.A., UCF College of Medicine
Adam Foley, B.S., UCF College of Medicine
Samantha Prabakaran, B.S., UCF College of Medicine
Kyle Sommerfield, B.S., UCF College of Medicine
Sub-Investigators: 
Sun Kim, B.A., UCF College of Medicine
Rachel Diem-Trang Truong, B.A., UCF College of Medicine
Investigational Site(s): 
UCF Health Clinic, 9975 Tavistock Lakes Blvd, Orlando, FL 
32827, (407) 266-4900
Introduction:  Researchers at the University of Central Florida (UCF) study many topics.  To do this 
we need the help of people who agree to take part in a research study. You are being invited to take 
part in a research study which will include about 25 people in the Central Florida area. You have been 
asked to take part in this research study because you are older than 18, have at least 2 lesion of 
Cutaneous Lupus Erythematosus (CLE), and have the ability to rate your level of pain and visual 
satisfaction from the topical and laser therapy for the treatment of CLE. You must not have started or 
have a change in your medication for cutaneous lupus erytehamtosus, not be pregnant, and not allergic 
to the topical medication (triamcinolone or betamethasone dipropionate) to be included in the research 
study
The persons doing this research are Dr. David Weinstein and Dr. Naveed Sami of UCF Health, with the 
assistance  of  Samantha  Prabakaran  and  Amelia  Winter,  medical  students  at  the  UCF  College  of 
Medicine. 
What you should know about a research study:

Someone will explain this research study to you. 
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020


2 of 6

A research study is voluntary.

Whether or not you take part is up to you.

You should take part in this study only because you want to.  

You can choose not to take part in the research study. 

You can agree to take part now and later change your mind. 

Whatever you decide it will not be held against you.

Feel free to ask all the questions you want before you decide.
New information developed during the course of the study which might affect the understandings in 
this consent and willingness to continue to participate will be brought to your attention.
Your participation in this study may be ended by the principal investigator or the sponsor if they feel it 
is in the interest of safety.
Purpose of the research study: Laser treatment is not currently an FDA-approved treatment of 
cutaneous lupus. The purpose of this study is to examine the effectiveness of two different types of 
laser in the treatment of CLE when used in addition to topical medications against the standard of care 
of topical medictions alone. 
What you will be asked to do in the study: 

During this study you will have 2 or 3 of your CLE lesions selected to be included in the study. 
All of the lesions selected will be treated with topical medication (i.e. hydrocortisone cream). 
Of these 2 or 3 lesions, 1 or 2 will additionally receive laser therapy.

Upon arrival at UCF Health, you will be given this consent form and the HIPAA Authorization 
form to read. You will be given the opportunity to ask any questions you may have. Afterwards 
you will asked to sign this document and the HIPAA Authorization before participation. You 
will be given instructions on how to care for skin before and after the laser treatments.

This study will require three visits to the clinic over the span of 8 weeks. 
o
First day of study (Visit 1): 

During this first visit, you will be assessed by Dr. Weinstien to determine if you 
can participate in the study. He will then determine which of your CLE lesions 
will be included in the study. 

Depending up on your skin type 1 or 2 of the lesions will receive treatment with 
a laser. Participants with lighter skin types will receive laser treatment to 2 
different lesions, each treated with a different laser. Participants with darker skin 
types will only receive laser treatment to one lesion as one of the lasers is not 
safe for use on darker skin.

After treatment with the laser you will rate the amount of pain felt during the 
treatment. Dr. Weinstein will be completing all laser treatment. 
o
4 weeks later (Visit 2):

During this visit you will again be assessed by Dr. Weinstien.

You will be asked about to rate the appearance of your lesions.
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020


3 of 6

The lesions treated before with the laser will again be laser treated a second time 

After treatment with the laser you will rate the amount of pain felt during the 
treatment.
o
4 weeks later (Visit 3):

This is the final visit and no laser treatment will take place.

During this visit you will again be assessed by Dr. Weinstien.

You will be asked about to rate the appearance of your lesions.

You will rate your final satisfaction in your visual appearance and answer some 
post-treatment questions

For the duration of your time in the study you will be required to apply the topical medication 
provided to you twice a day to the study lesions.

Photographs of the lesions being studied will be taken at each of the visits and stored in the 
electronic medical record.

Your responsibility is to remain truthful about all inquiries about the treatment. 
Location:  The study will be conducted at UCF Health.
Time required:  We expect that you will be in this research study for 30 minutes for each of the three 
visits over 8 weeks for a total of 1.5 hours over the course of the study. 
Risks: There are no major anticipated risks associated with the study. Potential risks include:
Risk for laser treatment:
Risks: greater than 50% chance

Pain/Discomfort – Additionally sharp burning/stinging pain can occasionally be felt. 
Risks: less than 10% chance

Redness/Swelling/Bruising – Short term redness (erythema) or swelling (edema) of the treated 
area is common and may occur. There also may be some bruising.

Skin Color Changes – During the healing process, there is a possibility that the treated area 
may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color 
compared to the surrounding skin.  This is usually temporary, but, on a rare occasion, it may be 
permanent.

Itching/Burning/Dry skin – Treatment may results in itching, burning, and/or dry skin during 
the recovery period. 

Red Rash/Bumps – Red rash/bumps may appear after treatment.  This resolves with time. 

Acne flare-up or cold sore – this may occur after treatment. 
Risks: less than 1% chance

Wounds – Treatment can result in burning, blistering, scabbing, or bleeding of the treated areas. 

Infection – Infection is a possibility whenever the skin surface is disrupted, although proper 
self-wound care should prevent this. 
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020


4 of 6

Scarring – Scarring is a rare occurrence, but it is a possibility when/if the skin surface is 
disrupted.  To minimize the chances of scarring, it is important that you follow all post-
treatment instructions provided by the research staff. 
Other laser treatment risks:

Sun Exposure / Tanning Beds / Artificial Tanning - May increase risk of side effects and 
adverse events mentioned above and must be avoided. 

Eye Exposure – Protective eyewear (shields or goggles) will be provided to you during the 
treatment.  Failure to wear protective eyewear during the entire treatment may cause severe and 
permanent eye damage.

Lack of improvement (procedure may not work) or worsening of your cutaneous lupus.
Risks for topical corticosteroid treatment:

Thinning of skin

Broken blood vessels

Stretch marks

Rash around the mouth

Increase in hair in treatment areas

Inflammation or irritation around hair follicles

Note: All risks are approximately less than 5%
There  may  be  uncommon  or  previously  unforeseen  risks.  You  should  report  any  problems  to  the 
researcher.
Benefits: While there are no guarantees that you will receive any benefits from participating in this 
study,  potential  benefits  include  quicker  improvement  of  your  cutaneous  lupus,  less  scarring  than 
standard of care, and topical treatment at no cost for cutaneous lupus for duration of study participation.
Alternatives: The alternative to choose to not participate in the study.
Compensation or payment:  You will not be receiving any compensation for your participation in the 
study.
Cost: There will be no cost to you or your insurance company to participate in this study. Please read 
about other possible costs in the following page under If you are harmed because you take part in 
this study.
Confidentiality:  We will limit your personal data collected in this study to people who have a need to 
review this information. We cannot promise complete secrecy. You may possibly be recognizable from 
some of the photographs taken of the lesions. Organizations that may inspect and copy your information 
include  the  IRB  and  other  representatives  of  UCF.  There  is  the  possibility  that  the  Food  and  Drug 
Administration  (FDA)  and/or  the  Office  for  Human  Research  Protections  (OHRP)  may  inspect  the 
research records.
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020


5 of 6
Monitors,  auditors,  IRB,  and  regulatory  authorities  will  be  granted  direct  access  to  all  participants’ 
original medical records for verification of clinical trial procedures and data, without violating your 
confidentiality,  to  the  extent  permitted  by  applicable  laws  and  regulations  and  that,  by  signing  the 
consent document, the you or your legally authorized representative is authorizing such access.
If the results of the trial are published, your identity will remain confidential.
Study contact for questions about the study or to report a problem: If you have questions, 
concerns, or complaints, or think the research has hurt you, talk to Dr. David Weinstein MD, UCF 
College of Medicine, UCF Health at david.weinstein@ucf.edu or Samantha Prabakaran, Medical 
Student, UCF College of Medicine at sprabakaran@knights.ucf.edu. 
IRB contact about your rights in the study or to report a complaint:    Research at the University of 
Central  Florida  involving  human  participants  is  carried  out  under  the  oversight  of  the  Institutional 
Review Board (UCF IRB). This research has been reviewed and approved by the IRB. For information 
about  the  rights  of  people  who  take  part  in  research,  please  contact:  Institutional  Review  Board, 
University of Central Florida, Office of Research & Commercialization, 12201 Research Parkway, Suite 
501, Orlando, FL 32826-3246 or by telephone at (407) 823-2901. You may also talk to them for any of 
the following: 

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You want to talk to someone besides the research team.

You want to get information or provide input about this research. 
If you are harmed because you take part in this study:  If you are injured or made sick from taking 
part in this research study, medical care will be provided. Depending on the circumstances, this care 
may be provided at no cost to you. Treatment for research related minor injuries will be made available 
at no cost by Dr. Weinstein if possible. For injuries that cannot be treated by Dr. Weinstein you will be 
referred elsewhere. Costs associated with this treatment may be billed to your insurance company. 
Costs not covered by your insurance company will be your responsibility. Contact the investigator for 
more information. 
Withdrawing from the study: You can withdraw from the study at any time during the study by 
contacting the principal investigator or co-investigators. If you decide to leave the research, data will 
no longer be collected from you and you are free to leave, however data collected up to that point will 
be used.  There will be no consequences for your choice to leave. If you decide to leave the study, 
contact the investigator so that the investigator can stop recording data from you. The principal 
investigator can also remove you from the research study without your approval. Possible reasons for 
removal include failure to follow instructions from staff or adverse reaction to one of the local 
anesthetic solutions.  The principal investigator can also end the research study early. We will tell you 
about any new information that may affect your health, welfare or choice to stay in the research. 
Withdrawal from this study will not affect your healthcare. 
 
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020


6 of 6
Your signature below indicates your permission to take part in this research and to the use and 
disclosure of your protected health information.
DO NOT SIGN THIS FORM AFTER THE IRB EXPIRATION DATE 
BELOW
Name of participant
Phone Number
Signature of participant 
Date
Signature of person obtaining consent
Date
University of Central Florida IRB
IRB Number: MODCR00000134
IRB Approval Date: 5/22/2019
IRB Expiration Date: 5/21/2020