EBIRE: Phase 1 Study of High Fluence LED-Red Light in Fitzpatrick Skin Types I to III
Phase: PHASE1
Conditions: Skin Diseases, Keloid, Scar, Fibrosis, Hypertrophic Skin
Sponsor: VA Northern California Health Care System

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EBIRE: Phase I Study of High Fluence LED-Red Light in Fitzpatrick Skin Types I to III 
VA File Number: 18-01-00804 
Funding Agency: EBIRE 
Principal Investigator: Jared Jagdeo, MD, MS 
January 12, 2018 
 
 

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Abstract 
Objective: To determine the safety of high fluence light emitting diode-red light (HF-
LED-RL) phototherapy in Fitzpatrick skin types I to III. 
Research Design: This study will be a single-blind, dose-escalation, randomized 
controlled, Phase 1 study of HF-LED-RL in Fitzpatrick skin types I to III. Subjects with 
Caucasian or white skin color (Fitzpatrick skin types I, II, or III) will be enrolled 
sequentially in groups of five (three subjects randomized to HF-LED-RL phototherapy 
and two subjects randomized to mock therapy). This study is based on the results of the 
previous “Phase 1 study of LED-RL in Human Skin” (VA file number: 15-12-00756), 
which demonstrated that HF-LED-RL doses up to 320 J/cm2 was safe in all skin types. 
One male subject with Fitzpatrick skin type V had an adverse event of a blister with HF-
LED-RL at fluence of 480 J/cm2. The other two subjects, who were of Fitzpatrick skin 
types I to III, treated with HF-LED-RL at fluence of 480 J/cm2 had no adverse event. 
Therefore, we wanted to explore the safety of HF-LED-RL at doses of 480 J/cm2 and 
640 J/cm2 in Fitzpatrick skin types I to III.   
The initial group will receive doses of 480 J/cm2 of HF-LED-RL or mock therapy at the 
Sacramento VA Medical Center Dermatology Clinic three times a week for three 
consecutive weeks, which is a standard phototherapy regimen based on phototherapy 
guidelines. An additional group (Group 2: 640 J/cm2) will be sequentially enrolled to 
receive a higher dose of HF-LED-RL phototherapy or mock therapy. If there is a single 
adverse event in either Group 1 or Group 2, we will repeat that same dose in a new 
cohort of five additional subjects (Group 1A or 2A, respectively). This is to account for a 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 3 of 40 
 
possible outlier effect. The maximally tolerated dose (MTD) will be defined as the dose 
level below the dose producing unacceptable but reversible adverse toxicity in two or 
more subjects. After either a MTD has been established or the endpoint dose of 640 
J/cm2 has been achieved, an additional 27 HF-LED-RL phototherapy subjects (for a 
total of 30 or 33) and 18 mock therapy subjects (for a total of 20 or 22), determined 
randomly, will be enrolled for a total of 50 subjects, such that it can be concluded with 
95% confidence that fewer than 1 person in 10 will experience an adverse event. 
Methods: Healthy subjects, any sex, ethnicity, and age with Fitzpatrick skin types I to III 
that do not meet exclusion criteria and whose nondominant proximal anterior forearm is 
wide enough to ensure reproducible placement of HF-LED-RL phototherapy or mock 
therapy hand-held unit will be recruited. Subjects with light-sensitive conditions or on 
photosensitizing medications, subjects with open wounds, diabetes, fibrotic skin 
diseases or other skin conditions affecting the nondominant proximal anterior forearm 
will be excluded from the study. Subjects with tattoos that cover the procedure site will 
also be excluded, as the tattoos may affect study findings due to altered light 
penetration or reflection. Subjects with Fitzpatrick skin types IV, V, and VI (darker skin 
phenotypes) and subjects who have participated in the “Phase 1 Study of LED-RL in 
Human Skin” (VA file number #15-12-00756) at the Sacramento VA Medical Center will 
be excluded. 
Clinical Significance: The effects of visible light, while common in our environment 
(visible spectrum accounts for 44% of total solar energy), remain undefined. An 
important safety feature of visible red light (600 nm to 700 nm) is that it does not 
generate pro-carcinogenic DNA damage as does ultraviolet (UV) light. Recently 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 4 of 40 
 
published clinical observations indicate that red light in combination with other 
modalities, such as photosensitizers in combined red light photodynamic therapy, can 
treat skin disease. However, preliminary in vitro data generated by our research group 
suggests that red light can function as a stand-alone treatment, eliminating the side-
effects of chemical photosensitizers and the potential long-term harm of current UV 
phototherapy. Furthermore, commercially available light emitting diode-red light (LED-
RL) units exist and are already FDA-cleared for other dermatological uses (such as 
rhytides and acne), thus clinical translation for use in skin diseases could occur 
relatively quickly following safety and efficacy demonstration. Currently, limited data 
exists pertaining to HF-LED-RL safety in different Fitzpatrick skin types. The uniqueness 
and importance of our study for medical science is that this will be the first clinical study 
of HF-LED-RL to evaluate the safety and regimen of these doses (480 and 640 J/cm2) 
in Fitzpatrick skin types I to III. Evaluating safety of HF-LED-RL phototherapy is 
important as HF-LED-RL may have the potential to treat skin diseases. To our 
knowledge, no clinical trials have been performed to determine the safety of HF-LED-RL 
in Fitzpatrick skin types I to III. Therefore, the innovation of this approach is that we 
intend to study the safety of HF-LED-RL modality in Fitzpatrick skin types I to III. 
 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 5 of 40 
 
List of Abbreviations 
HF-LED-RL, high fluence light-emitting diode-red light 
MRSD, maximum recommended starting dose 
MTD, maximum tolerated dose 
UV, ultraviolet 
Definitions 
Fitzpatrick Skin Types: A method to categorize a person’s skin based on his/her skin’s 
reaction to sun or ultraviolet light exposure (Table 1).(Fitzpatrick 1988) It ranges from 
type I (always burn, never tan) to type VI (never burn, always tan). In general, 
Caucasian or white skin color is considered Fitzpatrick skin types I, II, and III, while 
darker skin colors are considered Fitzpatrick skin types IV, V, and VI. 
Table 1. Skin type and sunburn sensitivity (Fitzpatrick Classification) (Fitzpatrick 1988) 
Fitzpatrick Skin Type Response to Sun Exposure 
Basic Skin Color 
I 
Always sunburns, never tans 
Pale white 
II 
Sunburns easily, develops a light  
Tan 
White 
III 
Sunburns moderately, develops a  
moderate tan 
White 
IV 
Sunburns minimally to rarely,  
develops a deep tan 
Light brown/olive 
V 
Never sunburns, develops a  
dark tan 
Brown 
VI 
Never sunburns, no noticeable  
change in skin color 
Black 
 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 6 of 40 
 
 
 
 
 
Contents 
Protocol Title: ............................................................................................................................. 7 
1.0 
Study Personnel .............................................................................................................. 7 
2.0 
Introduction ..................................................................................................................... 7 
3.0 
Objectives ......................................................................................................................12 
4.0 
Resources and Personnel ..............................................................................................12 
5.0 
Study Procedures ...........................................................................................................13 
5.1 Study Design ...................................................................................................................13 
5.2 Recruitment Methods.......................................................................................................29 
5.3 Informed Consent Procedures .........................................................................................32 
5.4 Inclusion/Exclusion Criteria ..............................................................................................32 
5.5 Study Evaluations ............................................................................................................35 
5.6 Data Analysis ..................................................................................................................35 
5.7 Withdrawal of Subjects ....................................................................................................36 
6.0 
Reporting ........................................................................................................................36 
7.0 
Privacy and Confidentiality .............................................................................................38 
8.0 
Communication Plan ......................................................................................................39 
9.0 
References ...................................................................................................................40 
 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 7 of 40 
 
Protocol Title:  EBIRE: Phase I Study of High Fluence LED-Red Light in Fitzpatrick 
Skin Types I to III 
 
1.0 Study Personnel 
Principal Investigator/Study Chair: Jared Jagdeo, MD, MS 
Research Personnel: Erica Wang, MD, (808)428-7082, ebkwang@gmail.com 
Ramanjot Kaur, MD, (916)765-3098, ramanj_bhandal@hotmail.com 
2.0 Introduction 
 
 
The effects of visible light, while common in our environment (visible 
spectrum accounts for 44% of total solar energy), remain undefined. An 
important safety feature of visible red light (600 nm to 700 nm) is that it does 
not generate pro-carcinogenic DNA damage as does ultraviolet (UV) light. 
Recently published clinical observations indicate that red light in combination 
with other modalities such as photosensitizers in combined red light 
photodynamic therapy can treat skin diseases. However, preliminary in vitro 
data generated by our research group suggests that red light can function as 
a stand-alone treatment, eliminating the side-effects of chemical 
photosensitizers and the potential long-term harm of current UV therapy. 
Furthermore, commercially available light emitting diode-red light (LED-RL) 
units exist and are already FDA-cleared for other dermatological uses (such 
as rhytides and acne), thus clinical translation for use in skin diseases could 
occur relatively quickly following safety and efficacy demonstration.  
 
We do not classify erythema (redness) lasting less than 24 hours as an 
adverse event in our study. Erythema is a common expected outcome that 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 8 of 40 
 
may occur in at least 10% of subjects as previously demonstrated in 
published studies.(Sadick 2008, Sadick 2008) Common expected procedure 
outcomes include: warmth, erythema (redness), and edema (swelling) that is 
expected to last less than 24 hours. To our knowledge, there are no animal 
studies that have utilized this device (Omnilux new-U) at these doses (480 
and 640 J/cm2). This device has a FDA 510K clearance, is sold for home 
use, and is generally regarded as safe in humans.  
 
In a randomized, controlled, dose escalation Phase I study of LED-RL in 
Human Skin (VA file 15-12-00756) conducted by our research group 
(hereinafter referred to as “previous Phase 1 LED-RL study”), we studied 
HF-LED-RL at doses of 160 J/cm2, 320 J/cm2, and 480 J/cm2 in all 
Fitzpatrick skin types. The maximum recommended starting dose (MRSD) of 
160 J/cm2 is based upon previously published maximum doses of LED-RL 
phototherapy used in clinical studies that demonstrated clinical safety with no 
adverse events. (Sadick 2008, Sadick 2008). In the “previous Phase 1 LED-
RL study”, the MRSD (160 J/cm2) was administered to Group 1 and the 
dose was escalated in subsequent groups using the classical method for 
dose escalation as described by Spilker: starting with dose (X) increased by 
an equal amount (in this instance: X=160 J/cm2, 2X=320 J/cm2, 3X=480 
J/cm2, 4X=640 J/cm2).  We demonstrated that the maximum tolerated dose 
(MTD) for HF-LED-RL was 320 J/cm2 in the “previous Phase 1 LED-RL 
study” based on an adverse event of a blister in one male subject with 
Fitzpatrick skin type V with HF-LED-RL at fluence of 480 J/cm2 (unpublished 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 9 of 40 
 
data). The other two subjects, who were of Fitzpatrick skin types I to III, 
treated with HF-LED-RL at fluence of 480 J/cm2 had no adverse event. 
48 subjects had no response or adverse event to any dose of HF-LED-RL or 
mock therapy. Eleven subjects had an expected, anticipated adverse event: 
One subject had faint erythema/redness that resolved after approximately 
one day (less than 48 hours) and ten subjects had transient post-
inflammatory hyperpigmentation (PIH), which is mild tanning.  
 
Currently, limited data exists pertaining to HF-LED-RL safety in different 
Fitzpatrick skin types. Fitzpatrick skin types is a method to categorize skin 
types based on their reaction to sun or ultraviolet light exposure.(Fitzpatrick 
1988) It ranges from type I (always burn, never tan) to type VI (never burn, 
always tan). In general, Caucasian (white) skin types are considered 
Fitzpatrick skin types I, II, or III while darker skin types are considered 
Fitzpatrick skin types IV, V, or VI. In the “previous Phase 1 LED-RL Study”, 
we did not evaluate or record Fitzpatrick skin types, but we recorded data for 
race and ethnicity based on National Institutes of Health (NIH) guidelines. 
Ethnicity and race corresponds closely with Fitzpatrick skin types as 
Caucasian skin types are Fitzpatrick skin types I to III and ethnic people are 
Fitzpatrick skin types IV to VI. Therefore, Fitzpatrick skin types scoring of 
subjects listed in ‘Part 1’ was based on race and ethnicity. 
 
We demonstrated in the “previous Phase 1 LED-RL study” that darker skin 
phenotypes (Fitzpatrick skin types IV, V, and VI) are more photosensitive to 
visible red light, as evident by an adverse event of a blister in one study 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 10 of 40 
 
subject with Fitzpatrick skin type V at 480 J/cm2 HF-LED-RL. The other two 
subjects, who were of Fitzpatrick skin types I to III, treated with HF-LED-RL 
at fluence of 480 J/cm2 had no adverse event. Therefore, we wanted to 
explore the safety of HF-LED-RL at doses of 480 J/cm2 and 640 J/cm2 in 
Fitzpatrick skin types I to III. This finding that skin of color subjects may be 
more photosensitive to HF-LED-RL than Caucasian subjects is significant to 
the scientific community because we demonstrated that Fitzpatrick skin 
types respond to visible red light differently than to ultraviolet light. Darker 
skin (Fitzpatrick skin types IV to VI) is photoprotective for ultraviolet 
wavelengths, but more photosensitive to HF-LED-RL than subjects with light 
skin (Fitzpatrick skin types I to III). This photosensitivity may be due to 
increased skin pigment melanin which absorbs visible light. This hypothesis 
is supported by and corresponds to clinical observations with the use of 
visible light laser therapy in patients with skin of color. Therefore, this study 
will investigate the differential effects of HF-LED-RL on Fitzpatrick skin types 
I to III.  
 
This Phase 1 study (Storer 1989 – Phase 1 study design) will establish the 
safety of HF-LED-RL up to 640 J/cm2 in human skin in this population of 
Fitzpatrick skin types I, II, and III. The results of this phase I study may 
establish differential safety of HF-LED-RL in Fitzpatrick skin types, which 
would determine dose stratification and treatment parameters for future 
clinical studies that use HF-LED-RL as a therapeutic modality. It may also 
determine what dose of HF-LED-RL is safe to use in Fitzpatrick skin types I 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 11 of 40 
 
to III. Upon successful demonstration of safety of HF-LED-RL in Fitzpatrick 
skin types I to III, future phase II studies may reference our phase I safety 
data to perform efficacy studies of HF-LED-RL in human skin for treatment of 
skin diseases. The uniqueness and importance of our study for medical 
science is that this will be the first study of HF-LED-RL in humans with 
Fitzpatrick skin types I to III to evaluate the safety and regimen of these 
doses (480 and 640 J/cm2). Evaluating safety of HF-LED-RL phototherapy is 
important as HF-LED-RL may have the potential to treat skin diseases. To 
our knowledge, no clinical trials have been performed to determine the safety 
of HF-LED-RL in Fitzpatrick skin types I to III. Therefore, the innovation of 
this approach is that we intend to study the safety of HF-LED-RL modality in 
Fitzpatrick skin types I to III.  
 
This randomized, controlled Phase 1 clinical study requires a study 
temperature-matched control, which is the mock therapy device. The mock 
therapy will serve as a control and help evaluate if side effects are due to 
HF-LED-RL light or the heat output that is emitted from the study device. If 
an adverse event occurs with the HF-LED-RL device only, then the HF-LED-
RL light may have caused the adverse event. If an adverse event occurs with 
the mock device only, then the adverse event may have been caused by the 
heat output. However, if the same adverse event occurs with both HF-LED-
RL and mock therapy at the same time duration, then the adverse event may 
have been caused by the heat output generated from both HF-LED-RL and 
mock devices. 

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 
Potential subjects who are willing and eligible for the study will be recruited 
from the Sacramento VA Medical Center, Mather. No vulnerable populations 
will be recruited to this study. Subjects with Fitzpatrick skin types IV, V, and 
VI will be excluded because the MTD for subjects with Fitzpatrick skin types 
IV, V, and VI was established in the “previous Phase 1 LED-RL study” as 
320 J/cm2 HF-LED-RL due to an adverse event of a blister in one study 
subject with Fitzpatrick skin type V at 480 J/cm2 HF-LED-RL. No subsequent 
testing of 480 J/cm2 was performed in subjects with Fitzpatrick skin types IV, 
V, and VI due to the study design of the “previous Phase 1 LED-RL study” 
where if any adverse event occurred, further testing at that dose would be 
discontinued. In this study, we will not test higher fluences of 480 J/cm2 and 
640 J/cm2 in subjects with Fitzpatrick skin types IV, V, and VI. Subjects who 
have previously participated in the “previous Phase 1 LED-RL study” will be 
excluded to maintain unbiased results. 
3.0 Objectives 
 
 The purpose of this study is to determine the safety of HF-LED-RL phototherapy 
in Fitzpatrick skin types I to III. 
 We hypothesize that HF-LED-RL phototherapy at fluences of 480 J/cm2 may be 
safe in subjects with Fitzpatrick skin types I to III.  We hypothesize that HF-LED-
RL phototherapy at fluence of 640 J/cm2 may be safe in subjects with Fitzpatrick 
skin types I to III. 

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4.0 Resources and Personnel 
 
 Location: Building 801, Dermatology Service, Sacramento VA, Mather, CA 
 Personnel: Jared Jagdeo, MD, MS (Attending Dermatologist, PI); Erica 
Wang, MD (Research Coordinator); Ramanjot Kaur, MD (Research 
Coordinator) 
 Dr. Jagdeo, Dr. Wang, and Dr. Kaur will have access to protected health 
information and will be involved in recruiting subjects, obtaining informed 
consent, administering survey/interview procedures, and performing data 
analysis. 
5.0 Study Procedures 
 
5.1 Study Design 
 This is a single-blind, randomized, ascending dose escalation 
Phase I study of HF-LED-RL in healthy subjects with Fitzpatrick 
skin types I to III to evaluate safety of HF-LED-RL in Fitzpatrick skin 
types I to III (Figure 1). The study endpoint of 640 J/cm2 is due to 
feasibility, as this dose corresponds to two  hours of HF-LED-RL 
irradiation, and we anticipate decreased subject compliance with 
HF-LED-RL exposures longer than 2 hours in duration. The study 
endpoint of 640 J/cm2 was also selected as this dose 
demonstrated increased anti-fibrotic properties in vitro compared to 
lower doses of HF-LED-RL (Mamalis 2015). Subjects will receive 
HF-LED-RL phototherapy or mock therapy three times a week for 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 14 of 40 
 
three consecutive weeks, which is a standard phototherapy 
regimen based on phototherapy guidelines (Anderson et al 2015, 
Menter et al 2010, Zanolli et al 2004). 
The HF-LED-RL light source is a commercially available Omnilux New-U 
hand-held LED-RL phototherapy unit (provided by Photo Therapeutics, 
Carlsbad, CA, USA), and is FDA-cleared for treatment of periorbital 
rhytides (crow’s feet) with doses up to 160 J/cm2. The temperature-
matched mock therapy unit, also provided by Photo Therapeutics, 
Carlsbad, CA, USA, generates only heat output comparable to heat 
generated by the HF-LED-RL device, which is less than two degrees 
Celsius of heat output, and does not emit HF-LED-RL.  
We do not classify erythema (redness) lasting less than 24 hours as an 
adverse event in our study, and is expected to occur in at least 10% of 
subjects as previously demonstrated in published studies (Sadick 2008, 
Sadick 2008). Common expected procedure outcomes include: warmth, 
erythema (redness), and edema (swelling) that is expected to last less 
than 24 hours.  
 
The maximum tolerated dose (MTD) is defined as the dose level below the 
dose producing unacceptable but reversible toxicity in two or more 
subjects (>20%) and is considered the upper limit of subject tolerance. If 
two or more subjects experiences any adverse event (including: first-
degree or higher skin burning or blistering, erythema lasting more than 24 
hours, swelling, pain, ulceration, infection, change in sensation, and/or 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 15 of 40 
 
muscle weakness), then this is the dose one above the MTD and we will 
not proceed with this dose or escalate the dose. The dose below the dose 
that generated the adverse event is the MTD. Rare but serious adverse 
events include second or higher degree skin burn, severe swelling, pain, 
ulceration, change in sensation, or muscle weakness leading to 
hospitalization, life-threatening events, or death.  
The data safety monitoring board (DSMB) includes: Dr. Rivkah Isseroff, 
Dr. Samuel Hwang, and Dr. Emanual Maverakis   
HF-LED-RL phototherapy and mock therapy at fluences of 480 J/cm2 or 
640 J/cm2 will be administered to 65 subjects with Caucasian (white) skin 
types (Fitzpatrick skin types I, II, and III) to determine safety of HF-LED-
RL at fluences of 480 J/cm2 and 640 J/cm2 in Fitzpatrick skin types I, II, 
and III. Because up to 320 J/cm2 HF-LED-RL was found to be safe in all 
Fitzpatrick skin types (unpublished data from “previous Phase 1 LED-RL 
study”), this study will study 480 J/cm2 and 640 J/cm2 in Fitzpatrick skin 
types I, II, and III based on Spilker’s dose escalation protocol (X=160 
J/cm2, 2X=320 J/cm2, 3X = 480 J/cm2, and 4X = 640 J/cm2).  
Number of subjects in each group: 
Group 1 (480 J/cm2; 3 or 6 HF-LED-RL phototherapy subjects and 2 or 4 
mock therapy subjects) - Total 5 or 10 subjects 
Group 2 (640 J/cm2; 3 or 6 HF-LED-RL phototherapy subjects and 2 or 4 
mock therapy subjects) - Total 5 or 10 subjects 

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Group 3 (480 or 640 J/cm2 depending on dose escalation algorithm; 27 
HF-LED-RL phototherapy subjects and 18 mock therapy subjects) - Total 
45 subjects 
* If there is one adverse event in one subject in either Group 1 or 2, five 
additional subjects will be added to that group (3 will receive HF-LED-RL 
and 2 will receive mock therapy).  
We based our dose escalation protocol for this new study on a similar 
Phase 1 dose escalation study design outlined in the Journal of National 
Cancer Institute (Le Tourneau et al 2009), to determine dose escalation 
and to account for a possible outlier effect in the treatment group. Dose 
escalation starts at fluence of 480 J/cm2 and continues up to fluence of 
640 J/cm2 until at least two subjects among a cohort of five to ten subjects 
experience an adverse event (i.e. >20% of subjects with an adverse event 
at that dose level).  
Our dose-escalation protocol is as follows (Figure 2): In the first group 
(Group 1), HF-LED-RL phototherapy or mock therapy treatment time 
durations associated with 480 J/cm2 will be administered to five subjects.   
Five subjects will be enrolled with three subjects randomized to HF-LED-
RL phototherapy and two subjects randomized to mock therapy. 
Randomization is performed with website: www.randomizer.org. The 
randomizer will generate arabic numerals (e.g. “1”, “2,” “3”). Each enrolled 
subject will undergo two randomizations. For the first randomization, “1” is 
Group 1, “2” is “Group 2” and “3” is Group 3. 10 subjects will be 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 17 of 40 
 
randomized to Group 1, 10 subjects will be randomized to Group 2, and 
45 subjects will be randomized to Group 3. If there are no adverse events 
in the first five subjects of either Group 1 or 2, then the remaining 5 
subjects of the 10 subjects randomized to that group will default into 
Group 3. For the second randomization, "1" is HF-LED-RL phototherapy 
and "2" is mock therapy. This study is single-blind and subjects will be 
blinded to this randomization, while researchers (Dr. Jagdeo, Dr. Wang, 
and Dr. Kaur) have knowledge of all subjects' randomization for the 
entirety of this study.   
Dose escalation starts at fluence of 480 J/cm2 and continues up to fluence 
of 640 J/cm2 until at least two subjects among a cohort of five to ten 
subjects experience an adverse event (i.e. >20% of subjects with an 
adverse event at that dose level). If there are no adverse events in the five 
subjects treated with HF-LED-RL or mock therapy at fluence of 480 J/cm2 
in Group 1, then we will escalate the dose of HF-LED-RL or mock therapy 
to fluence of 640 J/cm2 in the next cohort of five subjects (Group 2). If 
there is a single adverse event with HF-LED-RL or mock therapy at 
fluence of 480 J/cm2, we will repeat the same dose of 480 J/cm2 in a new 
cohort of five additional subjects (Group 1A). This is to account for a 
possible outlier effect. If two or more subjects in the first cohort of Group 1 
experiences an adverse event with HF-LED-RL or mock therapy at fluence 
of 480 J/cm2, then the study will stop and the MTD is 320 J/cm2. If there 
are no adverse events in Group 1A, then the dose will be escalated to 640 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 18 of 40 
 
J/cm2 in the next cohort (Group 2). If there is an adverse event in Group 
1A (>20%), then the study will stop and the MTD is 320 J/cm2. 
After either a MTD has been established or the study endpoint of 640 
J/cm2 has been achieved, an additional 27 HF-LED-RL phototherapy 
subjects (for a total of 30 or 33) and 18 mock therapy (for a total of 20 or 
22) (determined randomly) will be enrolled to satisfy Hanley's Rule of 
Three, such that it can be concluded with 95% confidence that fewer than 
1 person in 10 will experience an adverse event (Figure 3). (Hanley 1983) 
If the MTD is 320 J/cm2, then the study will be stopped and no further 
testing of the MTD of 320 J/cm2 in the larger cohort will be indicated 
because the MTD of 320 J/cm2 was already tested in a large cohort in the 
“previous Phase 1 LED-RL study”. Of the larger expansion cohort, the 
study will be halted (stopped) if adverse events determined to be device 
related equals or exceeds 30%.  
This clinical trial will be registered on https://clinicaltrials.gov following IRB 
approval and prior to subject enrollment. 
 The subject will receive standard of care treatment in the dermatology 
clinic for any adverse event. Physical examination/visual inspection of the 
treated forearm will occur at every study visit. Treatment will be initiated, if 
indicated, for any procedural outcomes or adverse events noted at every 
study visit. Any general dermatology adverse events will be managed by 
Dr. Jagdeo in the Dermatology clinic, per standard of care. If a skin ulcer 
occurs, we will record the skin ulceration as a superficial ulceration 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 19 of 40 
 
(meaning it is nearly flush with the skin) or, if measurable, the depth of 
ulceration in millimeters. If skin ulceration occurs, we will consult Dr. 
Rivkah Isseroff, who is an expert in wound healing and head of the 
Sacramento VA wound clinic, for management. If change in sensation or 
muscle weakness occurs in a subject, the subject will be sent to 
Sacramento VA Emergency Room for urgent grading and management. If 
there are any other adverse events that cannot be managed in the 
Dermatology clinic, the subject will be sent to the Sacramento VA 
Emergency Room for urgent care. 
 All procedures will occur in the Dermatology clinic at the Sacramento VA 
Medical Center (observed by Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur), 
three times per week for three consecutive weeks for total of nine study 
visits. Subjects will be counseled regarding common expected procedure 
outcomes including warmth, erythema (redness) and edema (swelling), 
found to resolve within 24 hours in other studies. (Sadick 2008) Any 
adverse events that occur in office during or immediately after HF-LED-RL 
phototherapy or mock therapy session will be recorded by Dr. Jagdeo. 
Subjects will be called on Mondays to serve as a reminder of upcoming 
study visits for the week. 
 Subjects will record daily any adverse events that occur at home using a 
subject diary of adverse events. The study diary will be completed 
approximately every 24 hours from the time of completion of the study 
procedure. The subject diary will have instructions on the first page and a 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 20 of 40 
 
chart on other pages for the subject to complete for every symptom noted 
at home (attached as separate document). The chart will have headers of 
‘Date,’ ‘Time Symptom Started,’ ‘Time Symptom Cleared,’ ‘Location,’ 
‘Describe the Symptom,’ ‘Severity,’ ‘Things that Make it Better,’ ‘Things 
that Make it Worse,’ ‘Any Treatments Tried at Home,’ and ‘MD Initial’. If a 
subject notices any changes sooner than 24 hours, they are encouraged 
to note it in their subject diary as soon as possible. If there are no 
changes, subjects will write “There are no changes.” Recording in a diary 
should take 0 minutes per day if there is no reportable change. It may take 
up to 3 minutes per day if there is a reportable change. If there are any 
reportable changes, subjects will describe reportable changes using the 
provided instructions and template. Prior to study procedure at every study 
visit, subjects will be asked about any adverse events that have occurred, 
including, but not limited to: erythema, blisters, swelling, pain, ulceration, 
infection, numbness, tingling, and weakness. Subject’s diaries will also be 
reviewed prior to study procedure at every study visit. Dr. Jagdeo, Dr. 
Wang, or Dr. Kaur will initial in the ‘MD Initial’ area at every visit, certifying 
that one of the researchers has reviewed the subject diary at every study 
visit. 
Study Timeline:  
HF-LED-RL Phototherapy or mock therapy procedure times are as 
follows:  
Group 1 (480 J/cm2; 3 or 6 HF-LED-RL phototherapy subjects and 2 or 4 
mock therapy subjects) - 90 minutes  
Group 2 (640 J/cm2; 3 or 6 HF-LED-RL phototherapy subjects and 2 or 4 
mock therapy subjects) - 120 minutes  

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 21 of 40 
 
Group 3 (480 J/cm2 or 640 J/cm2 based on dose escalation algorithm; 27 
HF-LED-RL phototherapy subjects and 18 mock therapy subjects) – 90 or 
120 minutes  
* If there is one adverse event in one subject in either Group 1 or 2, five 
additional subjects will be added to that group (3 will receive HF-LED-RL 
and 2 will receive mock therapy).  
Sample Timeline *Please see above list for procedure times for Groups 1, 
2, and 3.  
Week 0: (All subjects will be tested for photosensitivity with 20 
minutes and 106.7 J/cm2 of HF-LED-RL) 
Visit 1 
Screening and obtaining informed consent (10 minutes) Subject can return 
at a later date to sign the informed consent if he or she desires to review 
the consent form in more detail.   
Physical examination of nondominant forearm, pre-procedure photograph 
(5 minutes)  
Procedure for testing photosensitivity – HF-LED-RL phototherapy on 
nondominant upper forearm (20 minutes, 106.7 J/cm2)  
Post-procedure photograph (5 minutes) 
 
Visit 2 (24 hours after Visit 1) 
Physical examination of nondominant forearm for photosensitivity which 
includes warmth, erythema (redness), edema (swelling), rash, pain, 
sensory changes, muscle weakness, or discomfort lasting more than 24 
hours (10 minutes)  
Photograph (5 minutes) 
Subjects who are photosensitive will be excluded from this study. Subjects 
who are not photosensitive will proceed with study protocol.  
 
Week 1:  
Monday (Visit 3) 
Physical examination of nondominant forearm, pre-procedure photograph 
(5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Wednesday (Visit 4) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Friday (Visit 5) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 

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Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Week 2:  
Monday (Visit 6) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
 
 
Wednesday (Visit 7) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Friday (Visit 8) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Week 3:  
Monday (Visit 9) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Wednesday (Visit 10) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Friday (Visit 11) 
Physical examination of nondominant forearm, pre-procedure photograph, 
and review of subject diary of adverse events (5 minutes) 
Procedure (Refer to above for procedure duration)  
Post-procedure photograph (5 minutes) 
 
Average length of study visits for: Group 1 - 100 minutes, Group 2 - 130 minutes, 
Group 3 – 100 or 130 minutes based on dose escalation algorithm.  
 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 23 of 40 
 
Detailed Procedure: Intervention — Subject will be inside a private clinic exam 
room. The subject's nondominant proximal anterior forearm will be examined and 
cleaned with alcohol pads, A surgical marking pen will be used to mark three 
points to outline the procedure area at the start and completion of every session 
to ensure reproducible placement of the device. The HF-LED-RL phototherapy or 
mock therapy hand-held unit will be held in place and in direct contact with the 
cleaned area using non-adhesive tape (ACE elastic bandage or similar) during 
the procedure. Protective eyewear will be provided for all subjects to use at HF-
LED-RL phototherapy and mock therapy sessions. Dr. Jagdeo, Dr. Wang, or Dr. 
Kaur will be observing the procedure and assessing for any safety issues during 
and immediately post-procedure. Treatment will be started, if indicated, for any 
adverse events noted during physical examination at each study visit. 

Page 24 of 40 
 
 
Figure 1. Schematic of study design. 

Page 25 of 40 
 
 
 
Figure 2. Dose escalation algorithm. 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 26 of 40 
 
 
Figure 3. Expansion cohort design. 

Page 27 of 40 
 
 Subjects who receive HF-LED-RL phototherapy may have a greater risk 
compared to subjects who receive mock therapy. However, all subjects 
are closely monitored by Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur three 
times per week for three consecutive weeks at each study visit and by 
review of subject's diary of adverse events. All safety precautions, 
including sanitizing equipment and goggles with Sani-Wipe before each 
study subject use, requiring subjects to use safety googles during each 
session, and verifying subject identity, study procedure site of left or right 
forearm, and correct dose of HF-LED-RL or mock therapy, will be taken. 
All adverse events will be documented and if necessary, reported to the 
IRB. 
All HF-LED-RL phototherapy and mock therapy hand-held units will be 
cleaned with anti-germicidal wipes before and after each procedure. All 
subjects' nondominant proximal anterior forearm will be cleaned with 
alcohol wipes prior to placement of HF-LED-RL phototherapy or mock 
therapy unit. All subjects will be provided with protective eyewear during 
all procedures. The study procedure will occur on the subject's 
nondominant proximal anterior forearm, with a surgical marking pen to 
mark three points to outline the procedure area at the start and completion 
of every session to ensure reproducible placement of the device. Subjects 
will be asked which hand is dominant or preferred when writing. Subjects 
can report being left-handed, right-handed, or ambidextrous. Subjects who 
are ambidextrous may identify their preferred nondominant forearm for the 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 28 of 40 
 
study procedure to Principal Investigator (Dr. Jared Jagdeo) or study 
coordinators (Dr. Wang and Dr. Kaur) prior to start of study.  
In addition to the aforementioned precautions to minimize risks, all 
subjects will be screened by Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur by 
reviewing their medical records and performing a physical examination 
after obtaining informed consent. Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur 
will be present during HF-LED-RL phototherapy or mock therapy 
procedures, and observe and document any common expected procedure 
outcomes and adverse events. Any adverse event experienced by the 
subject will be evaluated and treated according to the standard of care. 
The study subjects have direct contact information (phone numbers and 
email addresses) of Dr. Wang, and Dr. Wang may be reached at any time. 
The Omnilux New-U hand-held HF-LED-RL phototherapy unit is 
commercially available and FDA-cleared for treatment of periorbital 
rhytides (crow's feet) with doses up to 160 J/cm2. We do not expect the 
risk of using HF-LED-RL phototherapy or mock therapy in our current 
study will be any different from the current FDA-cleared indication. 
 Potential subjects will be recruited from the Sacramento VA Medical 
Center, Mather, and any subjects who are willing and eligible for the study 
will be invited to participate. The total number of participants approved for 
recruitment is 200. 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 29 of 40 
 
5.2 Recruitment Methods 
 
 The total number of participants approved for recruitment is 200. 
 Potential subjects will be identified and recruited from the Sacramento VA 
Medical Center, Mather via discussion with Dr. Jagdeo, Dr. Wang, and/or 
Dr. Kaur in Dermatology Clinic or through subject interest from IRB-
approved flyers posted at the Sacramento VA Medical Center. 
 Flyer (Please see below and as separate attachment) 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 30 of 40 
 
Inviting Veterans to Participate in a Clinical Trial 
Studying the Safety of Red Light On Skin! 
 
The Dermatology Service is exploring the safety of a FDA-cleared red light 
device. To study the safety of red light, we are evaluating different treatment 
times using the device in healthy skin over a three-week period. We 
previously studied the safety of light in all skin types and this study is 
designed to investigate the effects of light on fair skinned individuals. 
 
Would you like to: 
- Help veterans and the population at large? 
- Make a contribution to medical science? 
- Help discover new treatments for skin disease? 
- Get compensated for your time participating in this study? 
 
PLEASE ASK US! 
 
Who may participate? 
- Veterans of any age, with Caucasian (white) skin that may burn easily.  
- Veterans who have not participated in a Sacramento VA red light study 
previously. 
- Veterans wanting to make a positive impact on others. 
 
Where is this study? 
- Building 801, Dermatology Clinic, Sacramento VA Medical Center, Mather 
 
If you are interested in participating in this study or if you have any 
questions, please contact research coordinator: 
 
Erica Wang, MD 
Phone: (808)428-7082 
 
 
 
 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 31 of 40 
 
 Subjects will receive a prorated amount of compensation based 
upon the number of completed study visits. Subjects must complete 
two or three study visits in the week to receive payment for that 
week. If patients complete two study visits in a week, they will 
receive a prorated payment of $33.33 for that week. If a subject 
completes three study visits in a week, they will receive a payment 
of $50 for that week. Completion of week 1: $50, week 2: $50, and 
week 3: $50. Patients will receive a check weekly and there will be 
no delay in receiving the payment. If a subject misses two or more 
study visits total, he/she will be discontinued from the study.   

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 32 of 40 
 
 
5.3 Informed Consent Procedures 
 
 Informed consent will be obtained using IRB-approved informed consent 
forms.  
 Informed consent will by obtained by Dr. Jagdeo, Dr. Wang, or Dr. Kaur. 
No persons with impaired decision-making capacity will be recruited to this 
study. Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur will determine whether the 
potential subject has decision-making capacity via conversational 
interaction with the potential subject. 
 Dr. Jagdeo, Dr. Wang, and Dr. Kaur has completed the CITI Human 
Research Subject training and has the knowledge and understanding of 
the clinical trial to obtain and document informed consent and explain the 
study to the subjects. 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion Criteria: 
1) Healthy subjects, any sex, ethnicity, and age with Fitzpatrick skin types I, 
II, or III that do not meet exclusion criteria. Fitzpatrick skin types will be 
determined based on NIH’s race/ethnicity categories. Fitzpatrick skin 
types I to III will be persons who are Caucasian or white. NIH defines 
“White” as “A person having origins in any of the original peoples of 
Europe, the Middle East, or North Africa.” A subject’s Fitzpatrick skin 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 33 of 40 
 
type, whether they are Fitzpatrick skin type I or II or III, will not be 
documented. 
2) Nondominant proximal anterior forearm is wide enough to ensure 
reproducible placement of HF-LED-RL phototherapy or mock therapy 
hand-held unit 
3) Available and willing to attend all study visits 
4) Able and willing to give informed consent 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 34 of 40 
 
Exclusion Criteria: 
1) Subjects with Fitzpatrick skin types IV, V, or VI 
2) Subjects on any photosensitizing medications (e.g. lithium, melatonin, 
phenothiazine antipsychotics, antibiotics) 
3) Subjects with light-sensitive conditions (Based on medical chart review, 
self-reporting, or failing the 20 minutes at fluence of 106.7 J/cm2 
photosensitivity evaluation) 
4) Subjects with diabetes mellitus (DM) (Based on medical chart review or 
self-reporting). Subjects with DM may have a higher risk of longer wound 
healing time. 
5) Subjects with a history of skin cancer: basal cell carcinoma (BCC), 
squamous cell carcinoma (SCC), or melanoma 
6) Subjects with systemic lupus erythematous (SLE) 
7) Subjects with open wounds on the nondominant proximal anterior 
forearm  
8) Subjects with fibrotic skin disease or other skin conditions on the 
nondominant proximal anterior forearm 
9) Subjects with tattoos that cover the procedure site on the 
nondominant proximal anterior forearm 
10) Subjects who previously participated in the Phase 1 study of 
LED-RL in Human Skin (VA file #15-12-00756) 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 35 of 40 
 
5.5 Study Evaluations 
 
 All subjects will be evaluated for photosensitivity (20 minutes with 
fluence of 106.7 J/cm2 of HF-LED-RL) prior to start of study 
procedures, as recommended by the manufacturer’s user guide 
instructions. A 20-minute session of HF-LED-RL phototherapy will 
be performed on the subject’s nondominant proximal anterior 
forearm, and evaluation for photosensitivity will occur 24 hours post 
HF-LED-RL phototherapy. Subjects will be excluded from the study 
if they fail the 20 minute photosensitivity evaluation or do not return 
for photosensitivity evaluation between 24-48 hours post HF-LED-
RL photosensitivity testing. Criteria for failing the photosensitivity 
testing include but are not limited to: warmth, erythema (redness), 
edema (swelling), rash, pain, or discomfort lasting more than 
24 hours. Subjects are required to complete a study diary and 
report any adverse events to Dr. Jagdeo, Dr. Wang, or Dr. Kaur. 
5.6 Data Analysis 
 
 Once all study subjects have finished all study procedures and data 
collection is complete, Dr. Jagdeo, Dr. Wang, and/or Dr. Kaur will 
then be performing the data analysis. Data analysis will include 
analysis of demographics (e.g. age, gender, ethnicity, race, 
Fitzpatrick skin type) in each cohort by HF-LED-RL or mock therapy 
dose, frequency of adverse events by HF-LED-RL or mock therapy 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 36 of 40 
 
groups, mean duration of erythema, total duration of erythema, and 
subgroup analysis by demographics of adverse events. Self-
reported outcomes of erythema duration are based on self-
reporting from subject’s diary. 
5.7 Withdrawal of Subjects 
 
 Subjects may be withdrawn from the research without their consent 
in the event of an adverse event that jeopardizes the subject’s 
safety or subject’s noncompliance (e.g. missing two or more study 
visits). In the event that subject’s study participation has to be 
discontinued, the principal investigator will explain to the participant 
the reasons for termination. 
 There are no consequences/penalties should a subject decide to 
withdraw from the research. The subject is encouraged to contact 
Dr. Wang for the end-of-study visit. End-of-study visit will include 
photograph of the treated forearm, physical examination of the 
treated forearm, and collection of the subject’s study diary. Subjects 
will be instructed to notify their primary care physician or follow-up 
in Dermatology clinic if any questions or concerns arise after the 
end of the study.   
6.0 Reporting 
 
 All subjects will be seen by Dr. Jagdeo (Principal Investigator), Dr. Wang, 
or Dr. Kaur. Study subjects are followed by their regular physicians, so 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 37 of 40 
 
they will continue to receive usual care. Dr. Jagdeo, Dr. Wang, or Dr. Kaur 
will review the study subject's safety parameters (including history and 
physical) after study enrollment. 
Although this is a minimal risk study, Dr. Jagdeo, Dr. Wang, or Dr. Kaur will 
monitor study subjects for common expected procedure outcomes and adverse 
events during and immediately after HF-LED-RL phototherapy or mock therapy. 
Monitoring will occur by direct observation and review of subject diary of adverse 
events at all study visits. 
Dr. Jagdeo (Principal Investigator) will promptly report any serious adverse 
events or unanticipated problems involving risks to study subjects in accordance 
with regulations: reportable adverse events arising from any of the study 
procedures will be submitted promptly to the IRB. Although they are not 
anticipated to occur, unanticipated problems (involving risks to subjects) or 
Serious Adverse Events (SAE) in subjects will be reported to the IRB within 5 
working days of awareness of the event. Copies of reports should be received by 
the IRB no later than 15 calendar days after the event.  
 Performance and Frequency of Safety Reviews 
Dr. Jagdeo (Principal Investigator) reports on the progress of the study on a 
quarterly basis at the DSMB meeting. Dr. Jagdeo (Principal Investigator) will 
monitor study progress, outcomes and subject safety, and may make 
recommendations on changes to the study protocol. Meetings regarding the 
performance and safety of this study will be held quarterly at the Dermatology 
Clinic Conference room. The DSMB will report to the IRB quarterly.  

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 38 of 40 
 
 Individuals who will perform the safety monitoring 
Rivkah Isseroff, MD (Chief, Dermatology Service) 
Samuel Hwang, MD (Chairperson, UC Davis Dermatology) 
Emanual Maverakis, MD (Associate Professor, UC Davis Dermatology) 
 
7.0 Privacy and Confidentiality 
 
 Dr. Jagdeo (Principal Investigator), Dr. Wang, and Dr. Kaur will have 
access to protected health information for the purpose of determining 
study eligibility, and for the performance of and collection of data 
associated with study related procedures. 
 We will collect only the minimum amount of the study subject's protected 
health information required to complete our study. To protect privacy, we 
will inform potential subjects of the minimum amount of personal 
information that would be required of them in order to participate in our 
study. Subjects are advised of the type and extent of information to be 
collected at the start of the study. Subjects will be consented individually in 
a private clinic office or exam room. 
 Electronic data are stored in the 
\\vhamacrchsmc\mac_research\JAGDEO_RESEARCH Server, and paper 
copies data are kept in a locked office in a locked research cabinet in 
Sacramento VA Medical Center, Building 801, Room 8. Data will be 
anonymized for statistical analysis, with new unique identifiers linked to 

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 39 of 40 
 
study subjects. Photographs of the forearm undergoing the intervention 
will be taken before and after each session. Photographs will be taken 
with a VA-provided and authorized camera. Photographs will be saved to 
the VISTA imaging component of CPRS as part of the subject's VA 
medical record. Files saved on the camera prior to upload will be deleted 
once uploaded to subject's CPRS file. 
8.0 Communication Plan 
 
 N/A   

VANCHCS Protocol Version 01/12/2018                                                                                                    Page 40 of 40 
 
 
9.0 References 
Bibliography of cited literature: 
 
Anderson KL, Feldman SR. A guide to prescribing home phototherapy for 
patients with psoriasis: the appropriate patient, the type of unit, the treatment 
regimen, and the potential obstacles. Journal of the American Academy of 
Dermatology. 2015;72(5):868-78.e1. 
 
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. 
Archives of dermatology. 1988;124(6):869-71. 
 
Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? 
Interpreting zero numerators. JAMA. 1983 Apr 1;249(13):1743-5.  
 
Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer 
clinical trials. Journal of the National Cancer Institute. 2009;101(10):708-20. 
 
Mamalis A, Jagdeo J. Light-emitting diode-generated red light inhibits keloid 
fibroblast proliferation. Dermatol Surg. 2015 Jan;41(1):35-9. 
 
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, 
Gottlieb A, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, 
Bhushan R. Guidelines of care for the management of psoriasis and psoriatic 
arthritis: Section 5. Guidelines of care for the treatment of psoriasis with 
phototherapy and photochemotherapy. J Am Acad Dermatol. 2010 
Jan;62(1):114-35. 
 
Sadick NS. A study to determine the efficacy of a novel handheld light-emitting 
diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008 
Dec;7(4):263-7 
 
Sadick NS. Handheld LED array device in the treatment of acne vulgaris. J Drugs 
Dermatol. 2008 Apr;7(4):347-50. 
 
Zanolli MD, Feldman SR. Phototherapy treatment protocols for psoriasis and 
other phototherapy responsive dermatoses. 2nd ed. New York: Informa 
Healthcare; 2004.