Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis
Phase: EARLY_PHASE1
Conditions: Seborrheic Dermatitis
Sponsor: University of California, Davis

Revision date: Febraury 27, 2018 
 
PROTOCOL TITLE: Pilot study for the use of photodynamic therapy in the treatment of 
seborrheic dermatitis 
 
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1) 
Protocol Title 
Pilot study for the use of photodynamic therapy in the treatment of 
seborrheic dermatitis. 
 
2) 
Author of Protocol 
UC Davis Researchers: 
Principal Investigator:  Nasim Fazel, MD, DDS, Department of Dermatology 
Co- Principal Investigator:  Raja Sivamani, MD, MS, Department of Dermatology 
 
3) 
IRB Review History 
The IRB reviewed the protocol and requested that the FDA determines 
whether an IND is needed or exempt. 
 
4) 
Objectives 
a) To determine the efficacy of photodynamic therapy (PDT) in the treatment of 
seborrheic dermatitis. 
 
b) To determine how PDT alters the skin microbiome in subjects with seborrheic 
dermatitis before and after treatment. 
 
c) To determine how PDT alters sebum secretion rates in subjects with seborrheic 
dermatitis before and after treatment. 
 
We hypothesize that PDT will be efficacious in the treatment of seborrheic 
dermatitis. 
5) 
Background 
Seborrheic dermatitis is a common chronic inflammatory disorder with a prevalence 
estimated at 3-5% [1, 2].  Although the exact pathophysiology is unclear, seborrheic 
dermatitis is more prevalent in indviduals that are more heavily colonized with the 
Malassezia spp fungal organism, those with more residual sebum (for example in 
neuropathic patients such as in Parkinson’s disease), and in those with higher sebum 
production, which leads to more lipid byproduct build up [2]. Current topical 
treatments include the use of topical antifungals, topical steroids, and topical 
calcineurin inhibitors [3, 4]. The success of topical treatments requires long-term 
use and depends on the compliance of the patient. Furthermore, these treatments  
can expose patients to potential side effects such as atrophy, thinning of the skin  
and telangiectasias in response to topical steroids. Therefore, alternative therapies 
that provide long-term control are needed. 
 
This pilot project investigates the use of PDT may be useful in the treatment of 
seborrheic dermatitis based on the following: 1) The Malassezia spp is capable of 
forming biofilms [5], 2) PDT has been shown to be effective against Malassezia spp 
[6, 7], 3) PDT can break up bioflims of both bacterial and fungal origin [8], and 4) 

Revision date: Febraury 27, 2018 
 
PROTOCOL TITLE: Pilot study for the use of photodynamic therapy in the treatment of 
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benzoyl peroxide, a prooxidant treatment similar to PDT, has been shown to be 
effective in the treatment of seborrheic dermatitis [9]. 
 
6) 
Inclusion and Exclusion Criteria 
Healthy subjects 18 years or older with seborrheic dermatitis of the face will be 
included. 
 
Subjects who are taking systemic corticosteroids (at doses of prednisone greater 
than or equal to 5 mg daily) or antibiotics (PO, IM or IV) will have to undergo a 4 
week “wash-out” period before participating in the study. Subjects who are using 
topical anti-fungals, steroids, antibiotics, permethrin, or calcineurin inhibitors will 
have to wait 2-weeks before enrolling. Washout will only occur if subject signs this 
consent form and the prescribing physician advises for a washout following 
consultation. Women who have started new birth control regimens within the last 
two months will have to wait until two months after the start of their regimen. 
 
Recruited subjects will be permitted to use bland emollients, but they will instructed 
to refrain from using topical emollients such as PromiseSeb® which have been 
clinically studied for the treatment of seborrheic dermatitis. The exclusion criteria 
will also include the presence of other untreated inflammatory conditions (such as 
lupus, atopic dermatitis, or psoriasis) or untreated malignancies on the face 
(including skin cancers such as basal cell carcinoma, squamous cell carcinoma and 
melanoma). 
 
Any subjects with known or suspected hypersensitivity to any constituent of the 
study medication or a history of photosensitivity due to conditions such as lupus 
erythematosus and porphyria will be excluded. Subjects who have had 
photodynamic therapy (PDT) to the face for any reason within the past year will be 
excluded as well. 
Adults unable to consent, individuals under the age of 18, pregnant or breastfeeding 
women and prisoners will be excluded from the study.  
 
7) 
Study-Wide Number of Subjects 
12 
 
8) 
Study-Wide Recruitment Methods 
Patients will be recruited from the outpatient dermatology clinics in the department 
of Dermatology at UC Davis. We also recruit participants who live within a 100 
mile radius of the dermatology clinics in Sacramento. They will be reassured that 
their participation or non- participation in the study will not affect the level of 
clinical care received. 
Recruitment flyers are attached. 
 
9) 
Compensation to the Subjects 
At the end of visit two, the patient will be paid $40 for completing visits one and 
two. If the patient does not follow up for visit 2, they will receive no compensation. 
At the end of visit three, the patient will be paid an additional $20 for completing 

Revision date: Febraury 27, 2018 
 
PROTOCOL TITLE: Pilot study for the use of photodynamic therapy in the treatment of 
seborrheic dermatitis 
 
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visit three. We will make the payments using gift cards. 
 
10) Study Timelines 

Revision date: Febraury 27, 2018 
 
 
 
 
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The research subject will require 4 visits that are spaced 2-10 weeks apart as 
outlined in the attached protocol. Each visit will take a total of 1.5 hours. We 
estimate that each subject will participate for a total of 3-4.5 months from initiation 
of enrollment to completion of the study. 
 
11) Study Endpoints 
The primary endpoint of the study is recruitment of a sufficient number of patients 
(12) who complete two treatments of photodynamic therapy to the face with 
grading of the severity of seborrheic dermatitis before each treatment and after each 
follow-up period. 
 
The secondary endpoints for the study are obtaining swabs for microbiome analysis 
and facial sebum production rates before each treatment and after each follow-up 
period. 
 
12) Procedures Involved 
Duration of seborrheic dermatitis, previous treatments for seborrheic dermatitis and 
patient response to the treatments will be recorded. Facial photography will be done 
for grading the Seborrhea Area and Severity Index Face (SASI-F). All seborrheic 
dermatitis patients will be graded using the SASI-F [3]. This score is a composite 
score as follows: the area index, also known as the relative area of facial 
involvement, is denoted as a fraction of 1 with the normal hairline defining the 
boundaries of the face.  Erythema and scale are separately scored on a 5-point scale 
using the definitions used to conduct Psoriasis Area and Severity Index scoring (ie, 
0 = none, 1 = slight, 2 = moderate, 3 = striking, and 4 = exceptionally striking). 
The scores for erythema and scale are then summed and multiplied by the relative 
area of facial involvement ratio.  The maximal score is 8 whereas no involvement 
would have a score of 0.  The inclusion criteria will be similar to the previous trial 
that used the SASI-F in their analysis [3]. This study will consist of subjects with 
an erythema score of at least one with the presence of at an area index of 5% or 
more. 
This study will be a single blinded, randomized, intra-individual comparison study 
consisting of a total of 12 subjects.  Patients will be randomized by utilizing an 
online randomizer.  A power analysis is not truly applicable because this is a pilot 
study that utilizes a potential treatment for seborrheic dermatitis that has not been 
previously investigated.  We plan to  recruit up to 12 patients. The treatment will 
consist of split-face comparisons of no application of aminolevulinic acid (ALA) vs 
ALA application to either half of the face. Prior to ALA application, the face will be 
swabbed for microbiome analysis.  A schematic for the split-face study is shown in 
Figure 1.  After the ALA application, the subjects will incubate with the ALA on 
their face per the standard PDT protocol used at UC Davis Dermatology clinic for 
facial PDT treatments. The side of the face being treated will remain the same 
during all treatments.  The investigator applying the ALA to the patient will be 
aware of which side is receiving treatment and which side is not, but the patient 
will be blinded.  For the placebo, Demo Levulan Kerastick, which contains no active 
ingredient and is enclosed in same cardboard sleeve and cap, will be applied to the 
other side of the face to mimic the surface of the ALA application stick. 

Revision date: Febraury 27, 2018 
 
 
 
 
PROTOCOL TITLE: Pilot study for the use of photodynamic therapy in the treatment of 
seborrheic dermatitis 
 
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After the ALA incubation is completed, the subjects will be exposed to a treatment 
dose of blue light from a Blu-U unit  per UC Davis Dermatology clinic protocol for 
PDT treatments. 
Calibrated facial pictures will be used for blind grading utilizing the SASI-F scoring 
system. 
 
A flow diagram of the protocol is shown in Figure 2.  The topical ALA used for this 
study will be Levulan® Kerasticks (DUSA Pharmaceuticals, Inc.). Facial sebum 
production rate will be measured with SebuMeter®. The swabbing for the 
microbiome will be performed as non-invasive swabbing from the face that will not 
cause the patient any pain or discomfort.  For the blue light treatment, the total light 
dose to the face will be consistent with the currently used standard facial exposure 
PDT protocols at UC Davis. 
 
After the third visit, patients have the option of being seen in the regular 
dermatology clinics.  Based on the disease severity, a treatment modality will then 
be selected and administered for the untreated side of the face. 
 
The Levulan Kerasticks and Demo Levulan Kerasticks are stored at the 
Investigational Drug Services (IDS), a Division of the Pharmacy Departmen at the 
University of California, Davis. IDS dispenses the Kerasticks upon the 
investigators’ request.  
 
13) Data and Specimen Banking 
N/A 
 
14) Data Management 
This study will be a single blinded, randomized, intra-individual comparison study 
consisting of a total of 12 subjects.  A power analysis is not truly applicable because 
this is a pilot study that utilizes a potential treatment for seborrheic dermatitis that 
has not been previously investigated.  We plan to recruit up to 12 patients. 
 
SASI-F scores and the SebuMeter® measurements will be compared within the 
treatment group and an intra-individual comparison will be performed by paired 
statistical testing such as the paired t-test. A p-value of 0.05 or less will be 
considered significant.  All of the assessors will be blinded to the treatment groups. 
The primary endpoint will be complete clearance of the seborrheic dermatitis as an 
intra-individual comparison and statistically analyzed with a two-sided paired t-test. 
All participants will be included in the study on an intent-to-treat basis. 
 
15) Provisions to Monitor the Data to Ensure the Safety of Subjects 

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The subjects will be monitored clinically during the treatment for any evidence of 
side effects such as pain or blisters. All of the treatments are done with topical 
ALA, which is an FDA approved drug. 
 
No regular blood draws or labs will be necessary.  No systemic effects are 
anticipated because all of the treatments are localized topical applications. 
 
However, the patient will be given a contact number on the consent forms in case 
there are any treatment related adverse effects such as erythema, blisters, pain, or 
secondary infection. Any side effects will be noted in a secure document. 
Secondary infections will be treated with appropriate antibiotics and local 
inflammation will be treated with topical steroids as necessary. 
 
16) Withdrawal of Subjects 
Subjects may be withdrawn without their consent if they acquire any medical issues 
during the study period which require the use of any other topical medications, oral 
or parenteral steroids, oral or parenteral antibiotics. They may also be withdrawn if 
they are found to have any abnormal sensitivity/allergy to the ALA. 
 
If a subject is to be withdrawn without their consent, they will be contacted and the 
reason(s) for their withdrawal will be explained in full. No further data will be 
collected from the subject. 
 
17) Risks to Subjects 
There is a low chance for any physical, psychological, social or legal injury from 
participation in the study. The patient will be warned of the standard risks of 
treatment with topical ALA including erythema, pain, blisters, increased temporary 
photosensitivity for 24 hours after treatments, and risk for hyper- and 
hypopigmentation. 
 
These potential adverse events will be localized and can be adequately managed 
and controlled with wound care and topical antibiotics, if the subject were to 
develop a secondary infection at the treatment sites. It is also possible, although 
unlikely, that the subject may develop contact dermatitis after exposure to the 
topical ALA. This can be adequately managed with topical steroids and topical 
antibiotics, if necessary. 
 
18) Potential Benefits to Subjects 
The individual subject may benefit from the treatment, but this cannot be 
guaranteed since this study aims to explore the efficacy of PDT in the setting of 
seborrheic dermatitis.  The greater community of patients with seborrheic dermatitis 
would benefit as this study would provide more insight into the efficacy of PDT for 
the treatment of seborrheic dermatitis. 

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Given that half of the subjects’ face will receive the standard PDT treatment, as per 
the dermatology clinic protocol for actinic keratoses on the face, there is the 
possibility that the treatments will concurrently treat their actinic keratoses. 
 
19) Vulnerable Populations 
N/A 
 
20) Multi-Site Research 
N/A 
 
21) Community-Based Participatory Research 
N/A 
 
22) Sharing of Results with Subjects 
N/A 
 
23) Setting 
The subjects will be recruited from the patients that attend the dermatology clinics 
at the UC Davis Dermatology clinic. 
 
Research activities will be conducted at the UC Davis Dermatology Department 
(3301 C Street, Suite 1300/1400). 
 
24) Resources Available 
The Dermatology department and clinic at UC Davis is available for use and the 
support staff within the department should be sufficient to conduct the study. 
The personnel involved in this study, their qualifications and their roles are as 
follows: 
Nasim Fazel, MD, DDS, MAS: Clinical Associate Professor, Principal 
Investigator. 
-Experienced dermatologist with expertise in both seborrheic dermatitis and PDT. 
-Role: Study design, grading of treatment site, involved in PDT procedure, patient 
recruitment, facial photography, specimen collection, and data analysis. 
Raja Sivamani, MD, MS: Assistant Professor of Dermatology, Co-Principal 
Investigator. 
- Experienced in the use of PDT. 
-Role: Study design, patient recruitment, involved in PDT procedure,  facial 
photography, specimen collection, grading of treatment site, and data analysis 
Research assistants: Undergraduate students, medical students and junior 
specialist. 
 

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- Role: Patient recruitment, blue light exposure, facial photography, specimen 
collection, organization of data 
Coordinators:  
- Role: Patient recruitment, blue light exposure, facial photography, grading 
of treatment site, specimen collection, data analysis 
 
Seborrheic dermatitis is one of the most common conditions encountered in 
dermatology and among our patients. Therefore, we will have a sufficient 
recruitment pool to meet our required number of subjects. 
 
Photodynamic therapy is frequently used at the Dermatology clinic and we do 
not expect significant adverse effects. However, the patient will be asked to 
contact the dermatology attending on-call in the event that there is an adverse 
effect. 
 
To ensure that all assisting personnel are aware of the research protocols, we will 
have a pre-recruitment meeting followed by regularly scheduled meetings to 
discuss duty expectations, the protocol, study progress, and any changes as 
needed. 
 
 
25) Prior Approvals 
N/A 
 
26) Recruitment Methods 
We will recruit from the patients that attend the outpatient dermatology clinic at UC 
Davis using flyers with contact numbers of the research team. We also use UC 
Davis Study Pages website. Patients will be assured that their clinical care will not 
be affected by their participation or non- participation in the study. 
 
Recruitment flyers are attached. 
 
27) Local Number of Subjects 
A total of 12 subjects will be recruited. 
 
28) Confidentiality 
This study is not a multicenter study. All of the data will be stored in secured data 
files in a password-protected computer within a locked room. All of the subjects 
will be coded with the codes listed in a separate password protected file.  All paper 
files of the subjects will be stored in a locked cabinet within a locked room. Dr. 
Fazel, Dr. Sivamani, and the research coordinator will have access to the paper files 
and password protected data files. 
 
Subjects’ images may be used for educational purposes, publications and/or 
presentations at conferences, and scientific meetings.  Pictures will be used without 
using any identifying information or features.  We will follow the institutional policy 
for the use of recorded material for educational purposes and/or presentations at 

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conferences, scientific meetings etc... that is outside of the research: 
http://intranet.ucdmc.ucdavis.edu/policies/hospital_policies_and_procedures/consents
_legal_documents/1426.shtml 
 
 
29) Provisions to Protect the Privacy Interests of Subjects 
To protect subjects' privacy interests, data and/or specimens will be labeled with a 
code that the research team can link to personal identifying information when 
acquired.  The code sheet will be secured and kept separate from the dataset.  Only 
authorized research personnel will have access to this information. All paper 
records containing study data will be stored in a study binder. This study binder 
will be securely stored in a locked cabinet, in a locked office, in the UC Davis 
Department of Dermatology at 3301 C St, Suite 1400, Sacramento, CA 95816. Any 
study-related electronic information will be kept in a password-protected computer 
database.  Only the PI, study staff, IRB and other authorized/designated governing 
bodies and individuals will be allowed to access these study-related documents. All 
HIPAA, IRB, State, and Federal policies and guidelines will be followed to ensure 
patient confidentiality. 
 
Patient photographs taken during this study will be handled according to the UC 
Davis Dermatology clinic protocol, which is as follows.  Photographs will be taken 
with the clinic’s cameras (which never leave the clinic), uploaded to the patient’s 
electronic medical record, and deleted from the camera. 
 
Interviews with patients will be conducted in a private clinic room. The participant 
may choose not to answer any or all of the questions during the interview, or they 
may stop the interview at any time, if they are uncomfortable or unsure about the 
study. 
 
30) Compensation for Research-Related Injury 
If the patient is injured as a result of being in the study, the University of California 
will provide necessary medical treatment.  Depending on the circumstances, the 
costs of the treatment may be covered by the University or may be billed to the 
patient’s insurance company. The University and the study sponsor do not 
normally provide any other form of compensation for injury. 
 
31) Economic Burden to Subjects 
The patient will need to come to the dermatology clinic for the PDT treatments. As 
such, they will need to pay for the expense of travel. Although this may be offset by 
compensation for participation in the study, the patient will need to pay for the 
travel expense ahead of receiving their compensation. 
 
32) Consent Process 
Written consent will be obtained from patients at the UC Davis outpatient 
Dermatology clinic in Sacramento.  We will be following the SOP: Informed 
Consent Process for Research.  After obtaining consent, there will be a two-week 
waiting period before initiating treatment so that the patient may begin using only 

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Dove soap and stop using any other products to their face. If the patient is using 
systemic treatment they will have to wait 4 weeks before participating, and if the 
patient is using topical treatment they will have to wait 2 weeks before participating. 
Patient will also be provided a moisturizer and sunscreen to use as needed. Patient 
will be encouraged to use sunscreen following PDT treatments.  
 
Only English-speaking, adult subjects who are not cognitively impaired and are 
able to consent will be recruited. 
 
33) Process to Document Consent in Writing 
 
Written documentation of consent process will be obtained (please see attached 
Consent document). This includes signing of the standardized consent form and 
HIPPA as well as an additional consent form that outlines permission to use 
photographs/recordings for publications/conferences/training purposes. In 
combination, this consent process will follow UCDHS policies related to this studya 
and allow use of photographs obtained for conferences/trainings /publications.  
 
34) Drugs or Devices 
Aminolevulinic acid (ALA) and the Blu-U unit are routinely used for delivering 
PDT treatments in the dermatology clinic. The Levulan Kerasticks and Demo 
Levulan Kerasticks will be at the Investigational Drug Services (IDS), a Division of 
the Pharmacy Departmen at the University of California, Davis. IDS dispenses the 
Kerasticks upon the investigators’ request. They will be used as per the UC Davis 
Department of Dermatology protocol for PDT treatments. PDT is not an 
investigational drug or device. 
Levulan Keastick is approved by the FDA for the treatment of actinic keratosis. The 
FDA has exempeted this protocol from the IND regulations. 
References: 
1. 
Palamaras, I., K.P. Kyriakis, and N.G. Stavrianeas, Seborrheic dermatitis: lifetime 
detection rates. J Eur Acad Dermatol Venereol, 2012. 26(4): p. 524-6. 
2. 
Sampaio, A.L., et al., Seborrheic dermatitis. An Bras Dermatol, 2011. 86(6): p. 
1061-71; quiz 1072-4. 
3. 
Papp, K.A., et al., Single-blind, randomized controlled trial evaluating the 
treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment 
compared with tacrolimus 0.1% ointment in adults. J Am Acad Dermatol, 2012. 
67(1): p. e11-5. 
4. 
Naldi, L. and A. Rebora, Clinical practice. Seborrheic dermatitis. N Engl J Med, 
2009. 360(4): p. 387-96. 
5. 
Figueredo, L.A., et al., Biofilm formation of Malassezia pachydermatis from dogs. 
Vet Microbiol, 2012. 
6. 
Lee, J.W., B.J. Kim, and M.N. Kim, Photodynamic therapy: New treatment for 
recalcitrant Malassezia folliculitis. Lasers in Surgery and Medicine, 2010. 42(2): 
p. 192-196. 
7. 
Lee, J.W., et al., Topical photodynamic therapy with methyl aminolevulinate may 
be an alternative therapeutic option for the recalcitrant Malassezia folliculitis. 
International Journal of Dermatology, 2011. 50(4): p. 488-490. 
8. 
Biel, M.A., Photodynamic therapy of bacterial and fungal biofilm infections. 

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seborrheic dermatitis 
 
 
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Methods Mol Biol, 2010. 635: p. 175-94. 
9. 
Bonnetblanc, J.M. and P. Bernard, Benzoyl peroxide in seborrheic dermatitis. 
Arch Dermatol, 1986. 122(7): p. 752. 

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Figure 1. Schematic for the split-face study. The C and M groups will be randomized to 
the right or the left side of the face by binary randomization. 
 
 
Figure 2. Seborrheic Dermatitis PDT Study Protocol 
 
 
 
 
 
 
 
 
 
END OF STUDY 
Visit 2 
1. Urine pregnancy test for female subjects. If the woman is postmenopasual or if the woman does not have a uterus, then they will be exempted from pregnancy testing 
2. Facial photography for SASI-F grading and erythema and scale grading 
3. Measure facial sebum production rates with SebuMeter® 
4. Apply ALA to treatment side and sham ALA to control side 
5. Incubate ALA for one hour 
6. Expose to blue light per UC Davis Dept of Dermatology standard protocol 
Visit 0 
1. Medical history and inclusion/exclusion criteria 
2. sign the consent forms 
Visit 1 
1. 
Urine pregnancy test for female subjects. If the woman is postmenopasual or if the woman does not have a uterus, then they will be exempted from pregnancy testing 
2. 
Facial photography for SASI-F grading and erythema and scale grading 
3. 
Swab facial sites for microbiome analysis 
4. 
Measure facial sebum production rates with SebuMeter® 
5. 
Apply ALA to treatment side and sham ALA to control side 
6. 
Incubate ALA for one hour 
7. 
Expose to blue light per UC Davis Dept of Dermatology standard protocol 
2-4 week interval 
2-4 week interval 
Visit 3 
1. Facial photography for SASI-F grading and erythema and scale grading 
2. Swab facial sites for microbiome analysis 
3. Measure facial sebum production rates with SebuMeter® 
Recruit total of 12 subjects 
Binary randomization for treatment of right versus left face as the control 
2-10 week interval