Clinical trial NCT02985736
Conditions: Psoriasis
Sponsor: Psoriasis Treatment Center of Central New Jersey
Start date: 2016-09-01; Completion date: 2017-01-27
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis

Detailed description:
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)

Arms: arm 1: None
Interventions: intervention 1: Topicort Topical Spray
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_SAP_000.pdf: 
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Clinical Study Protocol 
An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (desoximetasone) in Patients with 
Scalp Psoriasis 
Testing Facility 
Psoriasis Treatment Center of Central New Jersey 
59 One Mile Road 
East Windsor, NJ 08520 
(609) 443-4500 
 
Study Sponsor and Principal Investigator 
Jerry Bagel, MD 
 
 
Study Sub-Investigator(s) 
David Nieves, MD 
Brian Keegan, MD, PhD 
 
Institutional Review Board 
Western IRB 
1019 39th Avenue SE Suite 120
 
Puyallup, WA 98374 -2115 
 
 
 
 
 
 
 
 


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Table of Contents 
 
PROTOCOL TITLE PAGE 
1 
SYNOPSIS ................................................................................................ Error! Bookmark not defined. 
2 
ETHICS AND REGULATORY OBLIGATIONS 
............................................................................................. 5  
2.1 
Institutional Review Board (IRB) 
................................................................................................... 5  
2.2 
Ethical Conduct of the Study 
......................................................................................................... 5  
2.3 
Subject Information and Consent 
................................................................................................. 5  
 
3 INTRODUCTION ..................................................................................................................................... 5  
3.1 
Overview of Psoriasis 
.................................................................................................................... 5  
3.2 
Rationale for Treating Psoraisis with Biologic and Topical Therapy 
............................................. 6  
 
4 STUDY OBJECTIVE .................................................................................................................................. 6  
 
5 INVESTIGATIONAL PLAN ....................................................................................................................... 6  
5.1 
Overall Study Design and Plan 
...................................................................................................... 6  
5.2 
Study Population Criteria .............................................................................................................. 6  
5.2.1 
Inclusion Criteria ....................................................................................................................... 6  
5.2.2 
Exclusion Criteria ....................................................................................................................... 7  
5.3 
Source of Subjects and Recruitment Methods 
............................................................................. 7  
5.4 
Subject Enrollment and Treatment Assignment 
........................................................................... 7  
5.5 
Study Treatment ........................................................................................................................... 8  
5.5.1 
Topicort® Topical Spray 0.25% (desoximetasone) 
.................................................................... 8  
5.5.1.1 
Topicort® Description ............................................................................................................ 8  
5.5.1.3 
Topicort® Dosing Schedule 
................................................................................................... 8  
5.5.1.3 
Topicort® Dispensing and Dosage Record 
............................................................................ 8  
5.5.1.4 
Topicort® Dosage Adjustments ............................................................................................. 8  
5.5.2 
Permitted Concomitant Therapy 
.......................................................................................... 8  
5.6 
 Study Procedures and Assessments 
............................................................................................ 8  
5.6.1 
Informed Consent ..................................................................................................................... 8  
5.6.2 
Inclusion and Exclusion Criteria 
................................................................................................ 9  
5.6.3 
Demographics and Medical History 
.......................................................................................... 9  
5.6.4 
Urine Pregnancy Test 
................................................................................................................ 9  
5.6.5 
Physical Examination ................................................................................................................. 9  
5.6.6 
Investigator Global Assessment (Scalp Only) 
.......................................................................... 10 
5.6.7 
Psoriasis Scalp Severity Index and Scalp Surface Area 
............................................................ 10 
5.6.8 
Physician Global Assessment 
.................................................................................................. 10 


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5.6.9 
Body Surface Area ................................................................................................................... 10 
5.6.10 
Patient Reported Outcomes 
................................................................................................... 10 
5.6.11 
Early Discontinuation Procedures ........................................................................................... 10 
6. ADVERSE EVENTS 
.............................................................................................................................. 11 
6.1 
Adverse Events (AEs) ............................................................................................................... 11 
6.2 
Serious Adverse Events (SAEs) 
................................................................................................ 11 
6.2.1 
 SAE Reporting 
....................................................................................................................... 12  
6.3 
 
Pregnancy Reporting .............................................................................................................. 13  
7 INVESTIGATIONAL PRODUCT HANDLING 
.......................................................................................... 13  
7.1 IP Receipt 
................................................................................................................................ 13  
7.2 
Topicort® Storage .................................................................................................................... 13  
8 RECORD RETENTION 
........................................................................................................................ 13  
8.1 
Study Monitoring .................................................................................................................... 14  
8.2 
Statistics ................................................................................................................................. 14  
8.2.1 
Additional Statistical Considerations 
...................................................................................... 14  
10 REFERENCES 
.................................................................................................................................... 15  
11 APPENDICES 
.................................................................................................................................... 16  
 
 
 
 
 


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PROTOCOL SYNOPSIS: 
Study Title 
An Open -Label, Observational Study Evaluating 
Topicort® Topical Spray 0.25% 
(desoximetasone) in Patients with Scalp Psoriasis
 
Sponsors 
Jerry Bagel, MD  
Study Objectives 
Primary Objective: To explore the efficacy of Topicort® Topical Spray at weeks 4 
and 16 with respect to  Investigator Global Assessme nt (scalp only),  Psoriasis 
Scalp Severity Index (PSSI) , and Scalp Surface Area (SSA)
 
Secondary Objectives:  PGAxBSA, patient reported outcomes , adverse events  
 
Study Design 
A  single center, observational study of 2
0 subjects to assess 4 weeks of 
therapy 
with Topicort® BID and 12 weeks 
BID on two consecutive days a week 
patients 
with scalp psoriasis  
Study Centers 
Psoriasis Treatment Center of Central New Jersey
 
Study Population 
Adult male and female subjects with moderate to severe chronic plaque 
psoriasis  
Main Inclusion Criteria 
Subjects must meet the following criteria to be enrolled in this study:
 
1. Male or female adult 
≥ 18 years of age;  
2. Chronic scalp psoriasis ≥ 30% 
 
3. Investigator Global Assessment (scalp only) 
 of mild or greater 
 
Main Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from 
participation in this study:  
1. Subjects with non plaque type psoriasis (e.g. guttate
 and 
erythrodermic). 
2. Subjects with < 30% scalp psoriasis.
 
3. Use of prohibited medications  during study period.  
Study Drug Dosage and 
Administration 
All pati ents will receive Topicort ® BID for 4 weeks.  
After week 4 pat ients will receive Topicort  will receive Topicort®  BID on two 
consecutive days a week  for 12 weeks . Patients will treat other body areas 
affected by plaque psoriasis with Topicort® during the study period (excludes 
face, groin, axilla)  
Study Endpoints 
 
Improvement after  4 and  16 weeks of:  
Investigator Global Assessment (scalp only)
 
Psoriasis Scalp Severity Index  
Scalp surface area  
Physician Global Assessment x Body Surface Area 
Pain, itching, scaling (scalp only)
 
Scalpdex 
Study Duration 
16 weeks 
 
 


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2        ETHICS AND REGULATORY OBLIGATIONS 
2.1 
Institutional Review Board (IRB) 
Written IRB approval of this protocol must be obtained before the study is initiated.  Compliance 
with Title 21 of the US Code of Federal Regulations (CFR), Part 56, is required in order to protect 
the rights and welfare of human subjects involved in this study.   
2.2 
Ethical Conduct of the Study 
The study will be conducted in accordance with the ethical principles that have their origins in the 
Declaration of Helsinki and its amendments.  In addition, the study will be performed in compliance 
with Good Clinical Practices (GCP), including the archiving of essential documents. 
2.3 
Subject Information and Consent 
The Informed Consent Form will be reviewed and approved by the IRB.  The purpose, duration 
and possible risks and benefits will be explained to each potential subject.  Consent in writing 
must be obtained from the subject before enrollment into the study.  Consents will be signed and 
dated as required by Title 21 of CFR, Part 50.  The consent will also comply with the requirements 
of the Health Insurance Portability and Accountability Act (HIPAA).  The original, signed Informed 
Consent Form will be retained by the Investigator.  A signed copy of the Informed Consent Form 
will be given to the subject.  Each subject will be assigned a subject number that will be used in 
lieu of the subject’s name on further research documentation. 
 
 
3 
INTRODUCTION 
3.1 
Overview of Psoriasis  
Psoriasis is a chronic immunological disease characterized by infiltration of the skin with activated 
T cells and by abnormal keratinocyte proliferation and differentiation, resulting in marked 
inflammation and thickening of the epidermis.  Psoriasis affects 1-3% of the world population, 
making it one of the most prevalent inflammatory immunological diseases.1  There are several 
clinical subtypes of psoriasis: plaque, guttate, erythrodermic, inverse, and pustular.  Plaque 
psoriasis is the most common type of psoriasis affecting 75-80% of psoriasis sufferers.² It 
presents as raised silvery scale, which can cover large areas, with underlying erythema, itching, 
and discomfort.  
 
  
 
 
 


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3.2  
Rationale for Treating Scalp Psoriasis with Corticosteroid Topical Therapy  
Scalp psoriasis can have a significant psychosocial impact on a patient’s quality of life and the 
use of topical therapy has shown an increase in quality of life outcomes.3 Topical steroids play an 
in important role in the long term management of psoriasis.  Data from a study analyzing disease 
severity and patient treatment satisfaction revealed that patients with psoriasis are often 
dissatisfied with available treatments.4  Patient preferences of topical treatments can greatly 
impact compliance rates.  Recent evidence shows that spray is a patient preferred vehicle more 
than 2 to 1 over creams, ointments, lotions, gel and foams.5  This study will analyze improvement 
in scalp psoriasis and patient outcomes. 
 
4. STUDY OBJECTIVE 
To explore the effectiveness and safety of Topicort® Topical Spray for patients with scalp 
plaque psoriasis. 
 
5. INVESTIGATIONAL PLAN 
5.1 Overall Study Design and Plan 
20 subjects with at least mild scalp psoriasis and scalp surface area greater than or equal to 30%, 
will receive Topicort®  twice daily for 4 weeks followed by twice daily two times a week for 12 
weeks. 
5.2 Study Population Criteria 
Males and females ≥ 18 years of age with plaque type scalp psoriasis 
5.2.1 Inclusion Criteria 
Patients who meet all of the following criteria will be enrolled in the study: 
1. Male or female adults ≥ 18 years of age. 
2. Diagnosis of chronic plaque-type scalp psoriasis. 
3. IGA of mild or greater (scalp only) determined at screening 
4. Scalp surface area of 30% or greater determined at screening 
5. Able to give written informed consent prior to performance of any study related 
procedures. 
6. Females of childbearing potential (FCBP) must have a negative pregnancy test at 
Screening and Baseline.  FCBP who engage in activity in which conception is possible 
must use one of the approved contraceptive options:  hormonal contraception; 
intrauterine device (IUD); tubal ligation; or partner’s vasectomy; Male or female condom, 
diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with 
spermicide. 
7. Subject must be in general good health (except for psoriasis) as judged by the 
Investigator, based on medical history, physical examination. 


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5.2.2 Exclusion Criteria 
Patients will NOT be enrolled in this study if they meet any of the following criteria: 
1. <30% scalp surface area 
2. Scalp IGA clear or almost clear at time of screening 
3. Any condition, which would place the subject at unacceptable risk if he/she were to 
participate in the study. 
4. Pregnant or breast feeding, or considering becoming pregnant during the study.  
5. Use of any investigational drug within 4 weeks prior to randomization, or within 
5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 
6. Use of oral systemic medications for the treatment of psoriasis within 4 weeks 
(includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast 
and cyclosporine). 
7. Use of ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other 
experimental or commercially available biologic immune modulator(s) within 12 
weeks prior to the first IP dose.  
8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not 
including permitted topical therapy for face, groin and axilla). 
9. Patient received UVB phototherapy within 2 weeks of Baseline. 
10. Patient received PUVA phototherapy within 4 weeks of Baseline. 
11. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated 
in the label. 
5.3 
Source of Subjects and Recruitment Methods 
The Investigator will manage the recruitment of subjects upon approval of the study by the 
Institutional Review Board.  Subjects may be recruited from internal patient lists and outside IRB 
approved advertisements.   
5.4 
Subject Enrollment and Treatment Assignment 
20 subjects of either gender scalp plaque psoriasis will be enrolled to receive open-label 
Topicort® BID for 4 weeks followed by twice daily two days a week for 12 weeks. 


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5.5 STUDY TREATMENT 
5.5.1 Topicort® Topical Spray 0.25% (desoximetasone) 
5.5.1.1 
Topicort ® Description 
Topicort ® Topical Spray is a Class I, super-potent corticosteroid indicated for the treatment of 
plaque psoriasis in patients 18 years or older. Each gram of Topicort® Topical Spray 0.25% 
contains 2.5mg of desoximetasone in a clear, colorless liquid.   
5.5.1.2 
Topicort® Dosing Schedule 
Topicort® will be supplied by Taro Pharmaceuticals U.S.A. Inc. and applied approximately 12 
hours apart twice daily for 4 weeks followed by twice daily two times a week - on consecutive 
days - for 12 weeks (e.g. Saturday, Sunday). Patients will treat other body areas affected by 
plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla). 
5.5.1.3 
Topicort® Dispensing and Dosing Record 
Subjects will return all unused Topicort® to the study site.  Site personnel will keep a record of 
Topicort® dispensed to and returned by each subject and note any missed doses.   
 
5.5.1.4     Topicort Spray® Dosage Adjustments 
If an SAE or an adverse event that is thought to be related to Topicort® and is not alleviated by 
symptomatic intervention, Topicort® will be discontinued.  Subjects who permanently discontinue 
Topicort® therapy under this protocol should receive standard care of psoriasis treatment as 
prescribed by their physician. 
 
5.5.2  Permitted Concomitant Therapy 
Subjects may use non-steroidal topical medications to face, groin and axilla. Patients may apply 
Topicort Spray® on arms, legs and trunk to treat body psoriasis. Appropriate interventions (e.g., 
prescribed medications) may be performed as the investigator deems necessary to treat 
concomitant illnesses and/or safeguard the subjects’ wellbeing.  No investigational product or 
device may be used during the study.   
5.6 Study Procedures 
5.6.1 Informed Consent 
This Study will be conducted in compliance with CFR Title 21, Part 50 (Informed Consent of 
Human Subjects).  Informed consent will be obtained from each subject in writing before 
participation in the Study.  A signed copy of the Informed Consent Form will be provided to each 
subject.  A provision to obtain a signed authorization to provide protected health information to 


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the study sponsor, internal quality assurance agencies, health insurance agencies, and other 
parties as specified in the Federal Health Insurance Portability and Accountability Act (HIPAA) 
privacy regulation will be included in the Informed Consent Document.  HIPAA authorization is 
voluntary.  However, since the use and release of health information is critical to the conduct of 
the study, subjects who do not provide authorization to use and disclose their health information 
will not be enrolled into the study.  Subjects who withdraw their authorization to use and release 
health information during study participation will be formally discontinued from the study.  The 
investigator may use and release at any time all the information collected prior to a subject’s 
withdrawal of the authorization to all authorized parties to satisfy scientific, regulatory, and 
financial concerns. 
5.6.2 Inclusion and Exclusion Criteria 
Subjects’ eligibility to participate in the study will be determined according to the Inclusion and 
Exclusion Criteria during the screening period (0 – 30 days prior to the first dose of the study 
drug).  Subjects who ultimately do not satisfy the eligibility criteria except changing treatments 
and undergoing a washout period, will not be enrolled into the study.  Subjects who need to meet 
eligibility requirements will be asked to make the necessary changes.  Subjects who agree and 
comply will be re-evaluated prior to Baseline.  Subjects who meet the requirements at screening 
may be enrolled the same day. 
5.6.3 Demographics and Medical History 
The following information will be obtained for each subject during screening: date of birth, sex, 
race/ ethnic origin, relevant medical and surgical history, year of diagnosis of plaque psoriasis 
and scalp psoriasis, and current and previous anti-psoriasis treatments within the last 6 months.  
All current therapies for other medical conditions will be documented. Medical history will be 
reviewed and updated at the Baseline Visit to ensure that the patient remains eligible to participate 
in the study. 
5.6.4 Urine Pregnancy Test 
Pregnancy testing (urine β-human chorionic gonadotrophin [β-HCG]) will be conducted in all 
female subjects, except those without childbearing potential (e.g., one year post-menopause, 
post-hysterectomy, post-bilateral oophorectomy, etc) at Screening and Baseline Visit (Week 0) 
prior to the first dose of Topicort®.  An interim urine pregnancy test may be performed if there is 
reason to believe the subject may have become pregnant during the study.  Subjects with a 
positive pregnancy test will not be eligible to participate or to continue to receive study treatment. 
5.6.5 Physical Examination 
A physical examination, including vital signs measurements (blood pressure and pulse), will be 
performed at each study visit. Any clinically significant abnormalities discovered during physical 


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examinations after the Screening / Baseline (if occurring on the same day) visit should be 
documented and evaluated as potential adverse events. 
 
5.6.6 Investigator Global Assessment (scalp only)  
Investigator Global Assessment for scalp will be determined for all subjects throughout the study.  
Subjects are required to have a score of 2-mild or greater to enter the study.  The Investigator 
Global Assessment is a 5 point scale that records disease severity based on average degree of 
erythema, induration and scaling. Investigator Global Assessment uses a scale of 0 = Clear, 1 = 
Almost Clear, 2 = Mild, 3 = Moderate, and 4 = Severe. See Appendix A 
 
5.6.7 Psoriasis Scalp Severity Index (PSSI) and Scalp Surface Area (SSA) 
The scalp is assessed for erythema, induration and desquamation. The average degree of 
severity of each 3 symptoms is assigned a score of 0-4.  The surface area of scalp psoriasis is 
then estimated as a percentage. The PSSI score is the sum of the erythema, induration and 
desquamation scores multiplied by the area of involvement. Scores range from 0-72. See 
Appendix B 
5.6.8 Physician’s Global Assessment (PGA)  
PGA will be determined for all subjects throughout the study. PGA is a 5 point scale that records 
the overall disease severity at each clinical evaluation based on the average degree of erythema, 
induration, and scaling of areas affected by psoriasis.  PGA uses a scale of 0 = Clear, 1 = Almost 
Clear, 2 = Mild, 3 = Moderate, and 4 = Severe. See Appendix C 
 
5.6.9  Body Surface Area (BSA) 
BSA will be determined for all subjects throughout the study. The subjects palm will be selected 
for the measuring unit of body surface area.  The physician will equate the number of palms 
affected by psoriasis to derive the BSA total. 
5.6.10 Patient Reported Outcomes 
Subjects will complete the Subject Assessment of Pain, Itching and Scaling and Scalpdex at 
weeks 0, 4 and 16. Scalpdex is a self-administered quality of life instrument developed for scalp 
dermatitis. The 23 item survey evaluates the subject across 3 major domains –symptom, 
functional and emotion.6  Pain, Itching and Scaling is a scale of 1-10 which assess pain, itch and 
scale in the past 24 hours. See Appendix D and E 
 


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5.6.11  Early Discontinuation Procedures 
Subjects will be prematurely discontinued from the study under the following conditions: 
1. Subject requests to withdraw from the study. 
2. Subject is noncompliant with protocol schedule, restrictions, and/or requirements. 
3. Subject experiences an adverse event that makes it difficult or intolerable for the 
subject to continue treatment, or increases risk to the subject, or interferes with the 
investigator’s ability to clinically evaluate the progress of the subject’s treatment. 
4. Subject begins an unapproved concomitant therapy for psoriasis or another medical 
condition that may increase risk to the subject if continuing study treatment. 
5. Subject cannot be reached / lost to follow-up. 
6. The study investigator suspends or terminates the study. 
7. Other unanticipated reason. 
 
Any subject who prematurely discontinues the study should complete the week 16 (End of Study) 
assessments. Any subject who withdraws consent to participate in the study will be removed from 
further treatment and/or study observation immediately upon the date of request.  
6 
Adverse Events 
6.1 Adverse Events (AEs) 
An adverse event (AE) is any untoward occurrence in a subject, whether or not related to the 
product.  An AE does not necessarily have to have a causal relationship with the study treatment.  
AEs include events not present at baseline and events that worsened if present at baseline. 
Hospitalizations for pre-treatment conditions (e.g., elective cosmetic procedures) or surgeries that 
were planned prior to entry into the study are not considered adverse events.  
 
Adverse events, regardless of causality, will be captured from the signing of the Informed Consent 
Form and for the duration of the subject’s participation. 
6.2 Serious Adverse Events (SAEs) 
A serious adverse event (SAE) is any untoward medical occurrence that meets one or more of 
the following criteria according to federal regulations: 
 
a. results in death; 
b. is life-threatening (the subject was at risk of death at the time of the event.  It does not 
refer to an event, which hypothetically might have caused death if it were more severe); 
c. results in persistent or significant disability or incapacity; 
d. requires inpatient hospitalization or prolongation of existing hospitalization; 
e. is a congenital anomaly or birth defect; 


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f. is considered an important medical event (may not be immediately life-threatening or 
result in death or hospitalization but may jeopardize the subject or may require intervention 
to prevent one of the outcomes listed in the definition above). 
 
 
6.2 .1 SAE Reporting 
An Adverse Event or Suspected Adverse Reaction is considered ‘‘serious’’ if, in the view of 
either the investigator or sponsor, it results in any of the following outcomes: 
 
Death;  
 
A life threatening adverse event; (Note: the term “life-threatening” as used here 
refers to an event in which the patient was at risk of death at the time of the event; 
it does not refer to an event which hypothetically might have caused death if it 
were more severe);  
 
In-patient hospitalization or prolongation of existing hospitalization;  
 
A persistent or significant disability/incapacity (substantial disruption of the ability 
to conduct normal life functions); 
 
A congenital anomaly/birth defect; 
 
Any “other” important medical event. 
Important medical events that may not result in death, be life-threatening or require 
hospitalization may be considered Serious Adverse Events when, based on appropriate medical 
judgment, they may jeopardize the patient and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition.  
Regardless of the above, any additional adverse events which the Principal Investigator 
considers significant should be immediately reported to Taro’s Drug Safety Department. 
Any Serious Adverse Event, whether deemed drug-related or not, must be reported by the 
Investigator to the Taro’s Drug Safety Department by telephone within 24 hours after the 
Principal Investigator or Study Coordinator becomes aware of its occurrence.  The Principal 
Investigator or the Principal Investigator’s Designee must complete a Serious Adverse Event 
(SAE) Form and email it to Taro’s Drug Safety Department, along with the patient’s Adverse 
Events Log and Concomitant Medications Log within 24 hours of notification of the event.  
When appropriate, Taro’s Drug Safety Department will notify the U.S. Food and Drug 
Administration (FDA) of drug related Serious Adverse Events. 
Documentation of serious or unexpected adverse events and follow up information should be 
sent to Taro’s Drug Safety Manager within 24 hours from reporting the event by the Investigator. 
Following is the contact information: 
Taro Drug Safety Manager: 
Margo Wyatt, RN, BSN, 
Drug Safety Manager, Medical Affairs 
Taro Pharmaceuticals U.S.A., Inc. 
Tel:  914-345-9001 Ext. 6758 
Email: margo.wyatt@taro.com and taropvus@taro.com  
Taro’s Drug Safety Department must notify FDA of fatal or life threatening adverse event as 
soon as possible but no later than 7 calendar days from reporting the event by the Investigator 
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The Sponsor-Investigator must inform all participating Investigators of any SAEs within 15 
calendar days from reporting the event by the Investigator.  
 
 
6.3 Pregnancy  Reporting 
The investigator will notify Taro Pharmaceuticals U.S.A. Inc. within 24 hours of discovery about 
any female subject who becomes pregnant after starting Topicort®. The investigator will follow 
the pregnancy and outcome.  Any information gained will be shared with Taro Pharmaceuticals 
U.S.A. Inc.  Female subjects who become pregnant while using Topicort® will be discontinued 
from study treatment.   
 
7 INVESTIGATIONAL PRODUCT HANDLING 
 
7.1   Investigational Product Receipt 
At study initiation and as needed thereafter, Topicort® will be shipped to a responsible person at 
the investigator's institution, who will check the amount and condition of the drug, and maintain a 
record of this information. Taro Pharmaceuticals U.S.A. Inc. will instruct the Investigator on the 
return, disposal and/or destruction of investigational product and/or medical device materials if 
applicable. 
 
7.2   Topicort Spray® Storage 
Investigational product will be stored per the storage conditions identified on drug label.  At the 
study site, all IP will be stored in a locked, safe area to prevent unauthorized access. 
Records of the actual storage conditions during the period of the study will be maintained. 
 
8 RECORD RETENTION 
The investigator must retain these documents according to local laws or requirements. Essential 
documents include, but are not limited to, the following: 
  
 
Signed informed consent documents for all subjects;  
 
Subject identification code list, screening log (if applicable), and enrollment log;  
 
Record of all communications between the Investigator and the IRB/EC;  
Composition of the IRB/EC;  
 
Record of all communications between the Investigator and Taro. 
 
List of Sub-investigators and other appropriately qualified persons to whom the 
Investigator has delegated significant study-related duties, together with their roles in the 
study, curriculum vitae, and their signatures;  
 
Copies of CRFs (if paper) and of documentation of corrections for all subjects;   
 
IP accountability records;  


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 
Record of any body fluids or tissue samples retained; 
 
All other source documents (subject records, hospital records, laboratory records, etc);  
 
All other documents as listed in Section 8 of the ICH consolidated guideline on GCP 
(Essential Documents for the Conduct of a Clinical Trial). 
 
The Investigator must notify Taro Pharmaceuticals U.S.A. Inc.  if he/she wishes to assign the 
essential documents to someone else, remove them to another location or is unable to retain 
them for a specified period.  The Investigator must obtain approval in writing from Taro 
Pharmaceuticals U.S.A. Inc.  prior to destruction of any records.  If the Investigator is unable 
to meet this obligation, the Investigator must ask Taro Pharmaceuticals U.S.A. Inc. for 
permission to make alternative arrangements.  Details of these arrangements should be 
documented.  All study documents should be made available if required by relevant health 
authorities.  Investigator/Institution should take measures to prevent accidental or premature 
destruction of these documents. 
8.1 Study Monitoring  
The investigator will self-monitor all study records for accuracy, completeness, and compliance 
with the protocol and GCPs and federal regulations.  All study records will be made available to 
Taro Pharmaceuticals U.S.A. Inc. representatives upon request.  Study site facilities and study 
records will be made available to regulatory authorities’ inspectors if an inspection takes place.  
The investigator will notify Taro Pharmaceuticals U.S.A. Inc. if this occurs.   
 
8.2 Statistics 
It is desired to have approximately n=20 subjects at randomization. Analysis will be performed 
by the Investigator of Investigator Global Assessment of scalp, Psoriasis Scalp Severity Index, 
Scalp Surface Area, PGA x BSA and patient reported outcomes. The Investigator will also 
analyze SAE’s. 
 
 
8.2.1 Additional Statistical Considerations 
Additional statistical procedures may be detailed in and performed according to a separate 
statistical plan at the discretion of sponsor-investigator.  
 
 
 
 
 
 


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REFERENCES 
1. Greaves MW, Weinstein GD. Treatment of psoriasis. New Engl J Med. 1995;332(9):581-
8. 
 
2. Camp RDR. Psoriasis. In: Champion RH, Burton JL, Burbs DA, Breathnach SM, eds. Textbook of Dermatology, 6
th 
Edition. 1998;2:1589- 1649. 
3. Ortonne JP, Ganslandt  C, Tan J, Nordin P, Kragballe K, Segaert S. Quality of life in patients with scalp psoriasis 
treated with calcipitriol/betamethasone dipropionate scalp formulation: a randomized trial. Journal of the 
European Academy of Dermatology and Venereology Vol 23,
 Issue 8:919 -926 Aug 2009  
4. Korman NJ, Zhao Y, Lu J, Tran MH. Psoriasis disease severity affects patient satisfaction with treatment 
Dermatol 
Online J.  2015 Jul 15;21(7). pii: 13030/qt69h903m6. 
5. Keegan B. Desoximetisone 0.25% spray for the relief of scaling in adults with plaque psoriasis. Journal of Drugs in 
Dermatology 2015 Aug pp 611-615   
6. Chen SC, Yeung J, Chren M, (2002) Scalpdex; a quality of life 
instrument for scalp dermatitis. Arch Dermatol; 
138(6):803-7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8. APPENDICES 
Appendix A 
Investigator Global Assessment  
(Scalp Only) 
0 – Clear        
 
No signs of psoriasis. Post
-inflammatory 
 
hyperpigmentation may be present  
 
1 – Almost Clear 
 
Normal to pink coloration of lesions, no thickening, no minimal focal 
scaling 
 
2 – Mild disease 
 
Pink to light red coloration; just detectable to mild thickening, 
predominately fine scaling  
 
3 – Moderate disease 
 
Dull bright red, clearly distinguishable erythema, clearly 
distinguishable to moderate thickening, moderate scaling
 
 
4 – Severe disease 
 
Bright to deep dark red coloration, severe thickening with hard 
edges, 
severe/course scaling covering almost all or all lesions
 
 
 
 
 


J B-0 2  
 
V ersi o n 1      0 5 A pr 2 0 1 6 
 
1 7  
 
A p p e n di x B 
P s ori a si s S c al p S e v erit y I n d e x ( P S SI) a n d S c al p S urf a c e Ar e a ( S S A) 
 
Ps ori asis Sc al p S e v erit y I n d e x ( P S SI) a n d Sc al p S urf ac e Ar e a ( S S A) 
Er yt h e m a ( E)  
  
T hic k e ni n g  
  
Sc ali n g    
  
Sc al p S urf ac e Ar e a Sc or e 
Pl a q u e el e v ati o n                 D es q u a m ati o n ( D)  
S S A sc or e 
I n d ur ati o n (I) 
 
0 N o n e   
  
0 N o n e   
  
0 N o n e   
  
1 < 1 0 % 
1 Sli g ht   
  
1 Sli g ht   
  
1 Sli g ht   
  
2 1 0- 2 9 % 
3 M o d er at e  
  
3 M o d er at e  
  
3 M o d er at e  
 
3 3 0 - 4 9 % 
4 S ev er e   
  
4 S ev er e   
  
4 S ev er e   
 
4 5 0 - 6 9 % 
5 V er y S e v er e  
  
5 V er y S e v er e  
  
5 V er y S e v er e  
 
5 7 0 - 8 9 % 
  
  
  
  
  
  
  
  
  
6 9 0- 1 0 0 % 
 
 
Er yt h e m a  
  
T hic k e ni n g  
  
Sc ali n g    
  
Sc al p S urf ac e Ar e a Sc or e 
 
          
          
           
            
1   2  3  4   5   
1   2  3  4  5   
1   2  3  4    5   
1   2   3  4   5  6 
 
 
 
 
Sc al p S urf ac e Ar e a  
 R ec or d 0-1 0 0 %  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _%  
 
T ot al P S SI sc or e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
P S SI S C O R E = S U M O F S C O R E S F O R E R Y T H E M A, T HI C K E NI N G A N D S C ALI N G M UL TI PLI E D B Y S C AL P S U R F A C E A R E A  
(sc or es r a n g e fr o m 0-7 2)  
 


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Appendix C 
Physician’s Global Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix D 


J B-0 2  
 
V ersi o n 1      0 5 A pr 2 0 1 6 
 
1 9  
 
 
 
S u bj ect Ass ess m e nt of P ai n, Itc hi n g a n d Sc ali n g 
 
S el ect t h e n u m b er t h at b est d escri b es y o ur sc al p ps ori asis s y m pt o ms d uri n g t h e p ast 2 4 h o urs 
Pl e as e m ar k ( x) o n e b o x o nl y 
 
P ai n: O v er all, h o w s e v er e w as y o ur ps ori asis-r el at e d p ai n o v er t h e p ast 2 4 h o urs ? 
N o P ai n            P ai n as b a d as y o u c a n i m a gi n e 
                       1          2            3          4           5            6          7          8            9         1 0 
 
 
 
 
Itc hi n g: Ov er all, h o w s e v er e w as y o ur ps ori asis-r el at e d itc h ov er t h e p ast 2 4 h o urs ? 
N o Itc h            Itc h as b a d as y o u c a n i m a gi n e 
                       1          2            3          4           5            6          7          8            9         1 0 
 
 
 
 
Sc ali n g: O v er all, h o w s e v er e w as y o ur ps ori asis-r el at e d sc ali n g ov er t h e p ast 2 4 h o urs ? 
N o Sc ali n g           
Sc ali n g as b a d as y o u c a n i m a gi n e 
                       1          2            3          4           5            6          7          8            9         1 0 
 
 
 
 
 
 
 
 
 
 


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Appendix E 
 
 
 


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Appendix F 
Schedule of Assessments 
Procedure 
Screening Enrollment Week 4 
Week 8 
Week 
16 
Informed Consent 
X 
  
  
  
  
Demographics/Medical 
History 
X 
  
  
  
  
Inclusion/Exclusion 
X 
X 
  
  
  
Adverse Events 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
Investigator Assessments 
X 
X 
X 
X 
X 
Urine Pregnancy Test 
X 
X 
 
 
 
Scalpdex 
  
X 
X 
X 
Pain Itching Scaling 
  
X 
X 
  
X 
IP dispense/accountability 
  
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix G 
Dosing Diaries 
 
 
 
 
 
 


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