A Double-Blind, Multi-Center, Randomized, Placebo Controlled Safety, Tolerability & Efficacy Trial Of A New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adults
Phase: PHASE2
Conditions: Plaque Psoriasis
Sponsor: Santalis Pharmaceuticals, Inc.

Clinical Study Protocol No. SAN021-03 
Final 
Version 3.0 
08 August 2017 
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SANTALIS PHARMACEUTICALS 
Inclusion Criteria 
Subjects will be included in the trial if they meet all of the following 
Title 
A Multi-Center, Randomized, Placebo Controlled, Safety, 
Tolerability, and Efficacy Trial of a New Botanical Drug Product 
Containing East Indian Sandalwood Oil (EISO) at One Dose Level 
for the Treatment of Mild-to-Moderate Plaque Psoriasis in Adult 
Subjects 
Setting and Trial 
Center 
This trial will be conducted at approximately 5 study centers in the 
United States. 
Number of Subjects 
Up to 72 to ensure 60 complete the trial 
Objectives 
The objectives of this trial are: 
•
To evaluate the safety of SAN021 when administered to adult
subjects with mild-to-moderate plaque psoriasis
•
To evaluate the tolerability of SAN021 when administered to
adult subjects with mild-to-moderate plaque psoriasis
•
To evaluate the preliminary efficacy of SAN021 when
administered to adult subjects with mild-to-moderate plaque
psoriasis
Trial Design and 
Patient Population 
This trial will be a multi-center, randomized, placebo controlled 
study to evaluate the safety, tolerability, and efficacy of SAN021 
when administered for up to 42 days to adults between the ages 
of 18 to 65 years who have a clinical diagnosis of mild-to-
moderate plaque psoriasis.  
Subjects will enter the Screening Period once the informed 
consent and consent process has been completed. Subjects with 
mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area 
and Severity Index (PASI) score between 2 and 12,36 appropriate 
for topical treatment that covers a minimum of 1.0% and a 
maximum of 10% BSA, in the permitted treatment areas, and who 
meet all of the inclusion and none of the exclusion criteria will be 
enrolled.  
Once patient eligibility is confirmed and the screening procedures 
completed, all enrolled subjects will start the Treatment Period of 
the study.  All enrolled subjects will receive either 10% SAN021 or 
placebo serum (randomized in a 2:1 ratio) with the first dose 
applied at the Day 1 Study Visit. Subjects will be instructed on 
how to apply the study medication twice daily for 42 days.  
Subjects will return to the clinic for study-related assessments on 
Study Days 8, 15, 28 and a final visit on Day 42. On Study Day 
49, patient will receive a Follow-up phone call and be queried for 
condition status since going off study. 

Clinical Study Protocol No. SAN021-03 
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criteria: 
1. Are ≥18 but ≤65 years of age
2. Have a clinical diagnosis of mild-to-moderate plaque
psoriasis, as defined by a Psoriasis Area and Severity Index
(PASI) score between 2 and 12,36 appropriate for topical
treatment that covers a minimum of 1.0% and a maximum of
10% BSA, in the permitted treatment areas.
3. Are willing to treat all psoriasis occurring in the permitted
treatment areas with only SAN021
4. Are free of any systemic or dermatologic disorder, which, in
the opinion of the investigator, will interfere with the study
results or increase the risk of adverse events.
5. Are willing to avoid prolonged exposure of the treatment
area to ultraviolet radiation (natural or artificial) for the
duration of the study.
6. Are willing to refrain from using any lotions, moisturizer,
cleansers, cosmetics or creams, other than those issued as
part of the study, on the treatment areas during the
treatment period.
7. If female of childbearing potential, must be willing to practice
an acceptable form of birth control for the duration of the
study.(i.e. oral contraceptive, barrier method and/or intra-
uterine device)
8. Are able to give written informed consent in a manner
approved by the Institutional Review Board or Ethics Review
Committee and comply with the requirements of the study.
9. Are willing to avoid participation in any other clinical trial for
the duration of this study.
10. Are willing to refrain from treating restricted areas, which
will be excluded from PGA assessment and BSA calculation.
These areas are as follows: head, neck, fingernails, toenails,
soles of feet, and palms of hands, axillae, or intertriginous
areas.

Clinical Study Protocol No. SAN021-03 
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08 August 2017 
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Exclusion Criteria 
Subjects will be excluded from the trial if they meet any of the 
following criteria: 
1.
Have spontaneously improving or rapidly deteriorating
plaque psoriasis, or pustular psoriasis as determined by the
Investigator.
2.
Have been treated, with prescription medication for plaque
psoriasis, within 60 days prior to the Baseline visit.
3.
Are pregnant, breast-feeding, or planning to become
pregnant during the study.
4.
Have any evidence of systemic cancer, squamous cell
carcinoma, basal cell carcinoma, in the past 5 years, or any
other confounding skin condition.
5.
Are undergoing treatments with topical antipsoriatic drug
products other than corticosteroids within 14 days prior to
the Baseline Visit, and for therapy containing
corticosteroids or retinoids within 28 days prior to Baseline
Visit.
6.
Have open sores or open lesions in the treatment area(s).
7.
Have any condition that, in the opinion of the investigator,
would confound the safety and/or efficacy assessments of
plaque psoriasis.
8.
Have participated in any interventional clinical trial in the
previous 30 days.
9.
Have a known sensitivity to any of the constituents of the
test product including sensitivities to sandalwood oil,
fragrances, or any member of the Compositae family of
vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
10. Have used, are using, or are planning to use
immunosuppressive or immunomodulatory medication (i.e.,
biologics), including oral or parenteral corticosteroids.
11. Have a history of alcohol or illegal drug/substance abuse,
or suspected alcohol or illegal drug/substance abuse in the
past two years.
12. Plan to seek alternative treatment of any kind for their
psoriasis, in the eligible treatment areas or otherwise,
during the trial period.

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Screening (Day -7) 
Eligible subjects will be asked to read and sign an informed 
consent and photography consent form.  No study procedures will 
be conducted until the informed consent and photography consent 
forms are signed.   
At the Screening Visit, the following procedures will be performed: 
▪
Conduct the informed/photography consent process.
▪
Record Demographics to include age, sex, and race.
▪
Review the inclusion/exclusion criteria.
▪
Record all concomitant medications including all
prescription drugs, nonprescription drugs, and nutritional
supplements taken in the 60-days prior to Screening.
▪
Perform a full physical examination including height (cm)
and weight (kg).
▪
Record pertinent medical history including tobacco, illegal
substance and alcohol history and current use.
▪
Administer the Physician’s Global Assessment (PGA) and
the Psoriasis Area Severity Index (PASI).
▪
Calculate the plaque BSA of the area(s) to be treated.
Treatment Period 
Visit 1 Baseline (Day 1 [±2 Days]) 
Eligible subjects will have the following procedures completed at 
Visit 1 (Baseline). It is possible for the patient to be screened and 
complete the Visit 1 (Baseline) procedures on the same day. 
▪
Review inclusion and exclusion criteria to ensure the
patient qualifies for the study.
▪
If this visit is NOT combined with the screening visit:
o
Perform an abbreviated physical examination
including weight (kg),
o
Update concomitant medications including all
prescription drugs, non-prescription drugs and
nutritional supplements
o
Review and update the patient’s pertinent medical
history.

Clinical Study Protocol No. SAN021-03 
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o
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including
calculating the BSA of the affected area (only
treatment area(s) are to be evaluated).
▪
If patient is a female of childbearing potential, collect a
urine sample and perform a β-human chorionic
gonadotropin pregnancy test.
▪
Instruct the patient on proper washing of the target
treatment area(s) (using only study-approved cleanser) and
application of SAN021 study medication on the treatment
areas during the treatment period.
▪
Photograph the treatment area(s).
▪
Replace the cap with the dropper cap and weigh full bottle
of SAN021 study medication and record weight prior to on
site first dose.
▪
With the dropper cap on, weigh bottle of SAN021 study
medication post on site dose and dispense to subject.
▪
Instruct the subject to return in one week for the next study
visit with the study drug
Visit 2 (Day 7 [±2 Days]), Visit 3 (Day 14 [±2 Days]), Visit 4 (Day 
28 [±2 Days]) 
All study visits have a ±2-day visit window. 
▪
Query for adverse events.
▪
Update concomitant medications including all prescription
drugs, nonprescription drugs, and nutritional supplements.
▪
Query for treatment regimen compliance.
▪
Weigh and record the weight of the study medication and
re-dispense.
▪
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including calculating
the BSA of the affected area (only treatment area(s) are to
be evaluated).
▪
Photograph the treatment area(s).
▪
Review the directions for use of the study medication with
the patient, and re-educate if applicable.

Clinical Study Protocol No. SAN021-03 
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▪
Instruct the patient to return for the next study visit with
study drug.
Final Visit (Visit 5) 
Final Visit (Day 42 [±2 Days]) 
▪
Query for adverse events.
▪
Update concomitant medications including all prescription
drugs, nonprescription drugs, and nutritional supplements.
▪
Query for treatment regimen compliance.
▪
Collect and weigh the study medication and record the
weight.
▪
Complete the PGA (only treatment area(s) are to be
evaluated), PASI and tolerability assessment (only
treatment area(s) are to be evaluated) including calculating
the BSA of the affected area (only treatment area(s) are to
be evaluated).
▪
Photograph the treatment area(s).
▪
Instruct the patient to return for another study visit only if
study-related adverse events persist or, in the Investigator’s
opinion, an additional study visit is warranted to ensure the
patient’s safety.
Follow-up Call 
Follow-up Call (Day 49 [±2 Days]) 
•
Query for status of condition since going off study
o
i.e. has the condition been stable, worsened or
improved since discontinuing study medication?
Duration of Treatment 
and Trial Participation 
The maximum duration of trial participation for each patient is 
approximately 49 days: 
•
7-day Screening Period (Day -7)
•
Single-day Baseline Visit 1 (Day 1)
•
42-days of treatment (Visits 2 (Day 7), Visit 3 (Day 14),
Visit 4 (Day 28) and Final Visit (Day 42)
•
Follow-up Call (Day 49)
If the patient’s treatment is interrupted by illness or other 

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circumstances, every attempt will be made to have the patient 
return to the clinic for a final visit. 
Trial Population 
Up to 72 subjects, 18 – 65 years of age inclusive, with a clinical 
diagnosis of mild-to-moderate plaque psoriasis, as defined by a 
Psoriasis Area and Severity Index (PASI) score between 2 and 
12,36 that, in the opinion of the investigator, is appropriate for 
topical treatment, that covers a minimum of 1.0% and a maximum 
of 10% BSA, in the permitted treatment areas. 
Trial Drug, Dose and 
Mode of 
Administration 
Study medication will be provided by Santalis Pharmaceuticals. 
The following treatment product will be provided: 
▪
SAN021 10%  - to be used morning and night,
 OR 
▪
Placebo- to be used morning and night.
Subjects will also be provided with: 
▪
Cetaphil Gentle Skin Cleanser - to be used for the
duration of the trial.
The first treatment of SAN021 will be applied at the Baseline Visit, 
then patient will be instructed on the procedure for self-
administration at home. 
Criteria For Evaluation 
Subjects that receive one application of study medication will be 
included in the safety and tolerability analysis. 
Subjects that complete at least 80% of treatments, as determined 
by product usage, will be included in the efficacy analysis. 
Missing efficacy data will be imputed using the last observation 
carried forward.  No imputations will be made for missing safety 
data. 
Safety Evaluations 
The primary purpose of this study is to determine the safety profile 
of SAN021. 
Safety will be assessed by evaluating adverse events (AEs) with 
respect to severity, duration, and relationship to study drug.     
Tolerability 
Evaluations 
Tolerability will be based on the number of subjects reporting 
discomfort during or immediately following application of SAN021, 
This will also be recorded as an AE. The study restricted treatment 

Clinical Study Protocol No. SAN021-03 
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areas are to be not to be used in this evaluation. (see #10 under 
Inclusion Criteria) 
Preliminary Efficacy 
Evaluation 
Preliminary Efficacy Endpoints: 
The preliminary efficacy will be evaluated as follows: 
▪
Percentage of subjects achieving at least a 1-grade
improvement in PGA score
▪
Percentage of subjects achieving a 2-grade improvement in
the PGA score
▪
Percentage of subjects who have a ≥ 25% reduction in the
Psoriasis Area and Severity Index (PASI) score at any point
during the trial.
▪
Percentage of subjects who have a ≥50% reduction in the
Psoriasis Area Severity Index (PASI) score at any point
during the trial.
▪
Number of subjects achieving a Physician’s Global
Assessment of “clear” or “almost clear” at any time point
during the 42 days of therapy. The study restricted
treatment areas are not to be included in this evaluation.
(see #10 under Inclusion Criteria)
A. Physician’s Global Assessment (PGA): The PGA will be based
on a 5-point scale ranging from 0 (clear) to 4 (severe), and will be 
assessed, preferably by the same evaluator at each visit for the 
overall affected areas with plaque psoriasis which were treated 
with the study drug. The study exclusion areas and those areas not 
treated are not to be used in this assessment. The following scores 
will be used to describe the severity of overall plaque psoriasis of 
the treatable areas: 
Grade 
Score 
Description 
Clear 
0 
No signs of psoriasis (post-inflammatory 
hyperpigmentation may be present) 
Almost 
Clear 
1 
Intermediate between mild and clear 
Mild 
2 
Slight scaling plaque elevation, scaling, and/or erythema 
Moderate 
3 
Moderate plaque elevation, scaling, and/or erythema 
Severe 
4 
Very marked plaque elevation, scaling, and/or erythema 

Clinical Study Protocol No. SAN021-03 
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Data Analysis 
Safety  
The number and percentage of subjects reporting at least one 
occurrence of an AE for each unique System Organ Class and 
Preferred Term will also be tabulated by severity and by the 
relationship to trial drug.  All AEs will be presented in a data listing. 
Tolerability 
Tolerability will be based on the number of subjects reporting 
discomfort during or immediately following application of SAN021, 
this will also be recorded as an AE.  
Preliminary Efficacy 
The efficacy will be assessed as follows: 
▪
Percentage of subjects achieving at least a 1-grade
improvement in PGA score
▪
Percentage of subjects achieving a 2-grade improvement in
the PGA score
▪
Percentage of subjects who have a ≥ 25% reduction in the
Psoriasis Area and Severity Index (PASI) score at any point
during the trial.
▪
Percentage of subjects who have a ≥50% reduction in the
Psoriasis Area Severity Index (PASI) score at any point
during the trial.
▪
Number of subjects achieving a Physician’s Global
Assessment of “clear” or “almost clear” at any time point
during the 42 days of therapy. The study restricted
treatment areas are not to be included in this evaluation.
(see #10 under Inclusion Criteria)
Planned Dates of 
Study 
April 2017 to December 2017 

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Trial Contacts 
Name 
Affiliation / Address 
Responsibility 
Santalis 
Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA     
+1 (210) 558-8896
+1 (210) 694-9466
Sponsor 
Dr. Paul Castella, PhD Santalis Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA 
+1 (210) 558-8896
+1 (210) 694-9466
e-mail: paul@santalispharma.com
Sponsor 
Representative 
Somer Baburek 
Santalis Pharmaceuticals 
18618 Tuscany Stone, Suite 100 
San Antonio, TX 78258 USA 
+1 (210) 399-2322
+1 (210) 694-9466
e-mail: somer @ santalispharma.com
Sponsor – Study 
Manager