An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) BID in Psoriasis Patients Being Treated With Biologic Agents
Phase: PHASE4
Conditions: Psoriasis
Sponsor: Psoriasis Treatment Center of Central New Jersey

 
 
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Clinical Study Protocol 
An Open-Label, Observational Study Evaluating Topicort® Topical Spray 0.25% (desoximetasone) BID in Psoriasis 
Patients Being Treated with Biologic Agents 
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 
Physician’s Global Assessment .................................................................................................. 9 
5.6.7 
Body Surface Area ................................................................................................................... 10 
5.6.8 
Patient Reported Outcomes ................................................................................................... 10 

 
 
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5.6.9 
Localized Skin Reactions ......................................................................................................... 10 
5.6.10 
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 ....................................................................................................................... 11 
6.3  
    Pregnancy Reporting  .............................................................................................................. 12 
7    INVESTIGATIONAL PRODUCT HANDLING .......................................................................................... 13 
7.1            IP Receipt ................................................................................................................................ 13 
7.2 
Topicort® Storage .................................................................................................................... 13 
8    RECORD RETENTION  ........................................................................................................................ 13 
8.1 
Study Monitoring .................................................................................................................... 13 
8.2 
Statistics  ................................................................................................................................. 13 
8.2.1 
Additional Statistical Considerations ...................................................................................... 14 
9    REFERENCES ...................................................................................................................................... 14 
10  APPENDICES ...................................................................................................................................... 15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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PROTOCOL SYNOPSIS: 
Study Title 
Open Label, Observational Study, Evaluating Topicort® BID in Psoriasis Patients 
Being Treated with Biologic Agents. 
Sponsors 
Jerry Bagel, MD 
Study Objectives 
Primary Objective: To determine PGA x BSA improvement after 16 weeks of 
Topicort add-on therapy 
Secondary Objectives:  BSA x PGA, patient satisfaction 
Study Design 
A two-phase, single center, observational study of 20 subjects to assess 4 weeks 
of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a 
week to patients with ≤5% BSA who are receiving biologic therapy for at least 
24 weeks 
Study Centers 
Psoriasis Treatment Center of Central New Jersey 
59 One Mile Road, East Windsor, NJ 08520 
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. Diagnosis of chronic plaque-type  
        3.     Patient with ≤5% BSA 
        4.    Patient has been treated with biologic for a minimum of 24 weeks 
        5.  Able and willing to give written informed consent prior to performance     
of any study-related procedures. 
Main Exclusion Criteria 
Subjects who meet any of the following criteria will be excluded from 
participation in this study: 
1. >5% BSA 
2. Patient not receiving biologic agent, or receiving biologic agent 
<24weeks 
Study Drug Dosage and 
Administration 
All patients will receive Topicort® BID for 4 weeks. 
After week 4 patients will receive Topicort® BID  on two consecutive days a 
week for 12 weeks 
Study Visits 
Visit 1 (Screening) 
Visit 2 (Baseline) 
Visit 3 (Week 4) 
Visit 4 (Week 8)  
Visit 5 (Week 16) 
Study Endpoints 
 
Primary Endpoints: 
PGA x BSA improvement after 4 weeks and 16 weeks 
Patient satisfaction at week 4 and week 16 
Body Surface Area improvement at week 4 and week 16 
Physician’s Global Assessment improvement at week 4 and week 16 
Frequency of local skin reactions 
AE/SAE 

 
 
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Study Duration 
16 weeks 
 
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 
 
 
 

 
 
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presents as raised silvery scale, which can cover large areas, with underlying erythema, itching, 
and discomfort. 
 
 
3.2  
Rationale for Treating Psoriasis with Biologic and Topical Therapy 
Topical steroids play an in important role in the long term management of psoriasis. Data from 
the COBRA trial suggests that super potent topical corticosteroids are appropriate and well 
tolerated for use when added to existing therapeutic regimens.3 After 4 weeks of treatment, 80.0% 
of subjects in the add-on therapy group were clear or almost clear, or had an improvement in 
severity from baseline by 2 grades.4  Another study analyzing disease severity and patient 
treatment satisfaction revealed that patients with psoriasis are often dissatisfied with available 
treatments.5  Patient preferences of topical treatments can greatly impact compliance rates.  
Recent evidence shows that spray is a patient’s preferred vehicle more than 2 to 1 over creams, 
ointments, lotions, gel and foams.6 By combining biologic and topical corticosteroid therapy, 
efficacy and patient satisfaction outcomes are expected to increase. 
 
4. STUDY OBJECTIVE 
To explore the effectiveness and safety of combining Biologic Agents and Topicort® for patients 
with plaque psoriasis. 
 
5. INVESTIGATIONAL PLAN 
5.1 Overall Study Design and Plan 
20 subjects treated with a biologic agent for at least 24 weeks with a body surface area less than 
or equal to 5%, will receive Topicort®  twice daily for 4 weeks followed by twice daily BID on two 
consecutive days a week (e.g. Saturday and Sunday)  for 12 weeks. 
5.2 Study Population Criteria 
Males and females ≥ 18 years of age with moderate-to-severe chronic plaque 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 psoriasis. 
3. Able to give written informed consent prior to performance of any study related 
procedures. 
4. Treated with a biologic agent for a minimum of 24 weeks at baseline. 
5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%. 
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 

 
 
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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. 
5.2.2 Exclusion Criteria 
Patients will NOT be enrolled in this study if they meet any of the following criteria: 
1. >5% Body Surface Area 
2. Any condition, which would place the subject at unacceptable risk if he/she were to 
participate in the study. 
3. Pregnant or breast feeding, or considering becoming pregnant during the study.  
4. Malignancy or history of malignancy, except for: 
a. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;  
b. treated [ie, cured] malignancy with no evidence of recurrence within the previous 
5 years. 
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. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit 
(includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). 
8. Patient received UVB phototherapy within 2 weeks of Baseline. 
9. Patient received PUVA phototherapy within 4 weeks of Baseline. 
10. 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.   

 
 
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5.4 
Subject Enrollment and Treatment Assignment 
20 subjects of either gender with moderate-to severe plaque psoriasis will be enrolled to receive 
open-label Topicort® BID for 4 weeks followed by  BID on two consecutive days a week for 12 
weeks. 
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 (applied  2 
consecutive days) for 12 weeks.  
5.5.1.3 
Topicort® Dispensing and Dosing Record 
Topicort® will be dispensed to the study subjects by the authorized site personnel following 
instructions in Topicort® Label. 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 
The use of steroid-free topical emollients is allowed during the study.  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.   

 
 
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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 
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.  Screening and Baseline may occur on the same 
day if a washout is not required. 
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, medical and surgical history, year of diagnosis of plaque psoriasis, current 
anti-psoriasis treatments, 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) 

 
 
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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, will be performed at each study visit. 
Any clinically significant abnormalities discovered during physical examinations after the 
Screening / Baseline visit should be documented and evaluated as potential adverse events. 
5.6.6 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 A 
 
5.6.7  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. 
5.6.8  Patient Reported Outcomes 
Subjects will complete the satisfaction questionnaire at weeks 4 and 16 and dermatology life 
quality index (DLQI) at weeks 0, 4, and 16. Questionnaires should be prior to medical procedures 
and clinical evaluations.  See Appendix B 
 
5.6.9  Localized Skin Reactions 
Tolerability will be evaluated by the investigator using assessments of itching, dryness, 
burning/stinging, skin atrophy, striae, telangiectasia, and folliculitis.  Any reaction requiring use of 
concomitant therapy will be recorded as an adverse event. See Appendix C 
5.6.10  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. 

 
 
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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.  Events will be captured as observations 
from investigator or events reported by subjects from the signing of the informed consent form. 
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; 
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 

 
 
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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 
and within 15 calendar days for any other SAEs from the reporting of the event by Investigator.  
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 

 
 
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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. 
 
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 
• 
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;  
• 
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). 
 
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.  Study site facilities and study records will be 
made available to regulatory authorities’ inspectors if an inspection takes place.   
 
 

 
 
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8.2 Statistics 
It is desired to have approximately n=20 subjects at randomization. Analysis will be performed 
by the Investigator of PGA x BSA at weeks 4 and 16., PGA, BSA, and patient satisfaction at 
week 4 and 16. The Investigator will also analyze Frequency of local skin reactions and 
AE/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.  
 
9 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, 6th 
Edition.  1998;2:1589-1649. 
3. Koo JY. Relevance of the COBRA trial in current psoriasis practice. Cutis. 2007 Nov;80(5 Suppl):4-11. 
4. Jensen JD, Delcambre MR, Nguyen G, Sami N. Biologic therapy with or without topical treatment in psoriasis: 
what does the current evidence say? Am J Clin Dermatol. 2014 Oct;15(5):379-85. doi: 10.1007/s40257-014-0089-1. 
5. 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. 
6. 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    
 
7. Finlay AY, Khan GK.  Dermatology Life Quality Index (DLQI).  April 1992.  Available from:  www.dermatology.org.uk. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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10. APPENDICES 
Appendix A 
Physician’s Global Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix B 
Patient Reported Outcomes 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
Hospital No:  
 
 
 
Date:  
 
 
 
 
 
Name:  
 
 
 
 
 
 
 
 
Score: 
Address: 
 
 
 
 
Diagnosis: 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has 
affected your life OVER THE LAST WEEK.  Please tick  one box for each question. 
 
1. 
Over the last week, how itchy, sore,  
 
 
Very much 
 
 
painful or stinging has your skin    
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
Very much 
 
 
or self conscious have you been because  
A lot 
 
 
 
of your skin?  
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your   
 
Very much 
 
 
skin interfered with you going 
 
  
 
A lot 
 
 
 
shopping or looking after your home or   
 
A little  
 
 
garden?         
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
4. 
Over the last week, how much has your   
 
Very much 
 
 
skin influenced the clothes  
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
5. 
Over the last week, how much has your   
 
Very much 
 
 
skin affected any social or   
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
6. 
Over the last week, how much has your   
 
Very much 
 
 
skin made it difficult for  
 
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
7. 
Over the last week, has your skin prevented 
 
Yes 
 
 
 
you from working or studying? 
 
 
 
No 
 
 
Not 
relevant  
 
 
 
If "No", over the last week how much has   
 
A lot 
 
 

 
 
Version 3      11Apr2016 
 
17 
 
 
your skin been a problem at  
 
 
 
A little  
 
 
work or studying?  
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your   
 
Very much 
 
 
skin created problems with your   
 
 
A lot 
 
 
 
partner or any of your close friends 
 
 
A little  
 
 
or relatives?   
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
9. 
Over the last week, how much has your   
 
Very much 
 
 
skin caused any sexual  
 
 
 
 
A lot 
 
 
 
difficulties?  
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not 
relevant  
 
10. 
Over the last week, how much of a  
 
 
Very much 
 
 
problem has the treatment for your 
 
 
A lot 
 
 
 
skin been, for example by making  
 
 
A little  
 
 
your home messy, or by taking up time?   
 
Not at all 
 
Not 
relevant  
Please check you have answered EVERY question. Thank you.  
©AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the permission of the 
authors.7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Version 3      11Apr2016 
 
18 
 
Treatment Satisfaction Questionnaire for Medication (TSQM) - 9 
 
Instructions: Please take some time to think about your level of satisfaction or dissatisfaction 
with the medication you are taking in this clinical trial.  We are interested in your evaluation of 
the effectiveness and convenience of the medication over the last two weeks, or since you last 
used it.  For each question, please place a single check mark next to the response that most 
closely corresponds to your own experiences. 
 
1. How satisfied or dissatisfied are you with the ability of the medication to prevent or treat 
your condition? 
1 
Extremely Dissatisfied 
2 
Very Dissatisfied 
3 
Dissatisfied 
4 
Somewhat Satisfied 
5 
Satisfied 
6 
Very Satisfied 
7 
Extremely Satisfied 
 
2. How satisfied or dissatisfied are you with the way the medication relieves your 
symptoms? 
1 
Extremely Dissatisfied 
2 
Very Dissatisfied 
3 
Dissatisfied 
4 
Somewhat Satisfied 
5 
Satisfied 
6 
Very Satisfied 
7 
Extremely Satisfied 
 
3. How satisfied or dissatisfied are you with the amount of time it takes the medication to 
start working? 
1 
Extremely Dissatisfied 
2 
Very Dissatisfied 
3 
Dissatisfied 
4 
Somewhat Satisfied 
5 
Satisfied 
6 
Very Satisfied 
7 
Extremely Satisfied 
 
4. How easy or difficult is it to use the medication in its current form? 
1 
Extremely Difficult 
2 
Very Difficult 
3 
Difficult 
4 
Somewhat Easy 

 
 
Version 3      11Apr2016 
 
19 
 
5 
Easy 
6 
Very Easy 
7 
Extremely Easy 
 
5. How easy or difficult is it to plan when you will use the medication each time? 
1 
Extremely Difficult 
2 
Very Difficult 
3 
Difficult 
4 
Somewhat Easy 
5 
Easy 
6 
Very Easy 
7 
Extremely Easy 
 
6. How convenient or inconvenient is it to take the medication as instructed? 
1 
Extremely Inconvenient 
2 
Very Inconvenient 
3 
Inconvenient 
4 
Somewhat Convenient 
5 
Convenient 
6 
Very Convenient 
7 
Extremely Convenient 
 
7. Overall, how confident are you that taking this medication is a good thing for you? 
1 
Not at All Confident 
2 
A Little Confident 
3 
Somewhat Confident 
4 
Very Confident 
5 
Extremely Confident 
 
8. How certain are you that the good things about your medication outweigh the bad things? 
1 
Not at All Certain 
2 
A Little Certain 
3 
Somewhat Certain 
4 
Very Certain 
5 
Extremely Certain 
 
9. Taking all things into account, how satisfied or dissatisfied are you with this medication? 
1 
Extremely Dissatisfied 
2 
Very Dissatisfied 
3 
Dissatisfied 
 
 

 
 
Version 3      11Apr2016 
 
20 
 
Appendix C 
Local Skin Reactions Evaluation  
Burning/Stinging and Itching are reported by the subject. Dryness, Skin Atrophy, Striae, Telangiectasia, 
and Folliculitis are observed by the evaluating Investigator. 
Mark one score for each evaluation: 
Grade  
Itching 
(as reported by 
Subject within the 
last 24 hours) 
Mark 
Score 
Dryness 
(as observed by the 
Investigator) 
Mark 
Score 
Burning/Stinging 
(as reported by Subject 
within the last 24 hours) 
Mark 
Score 
None 
No itching 
 0 
No dryness 
 0 
No burning/stinging 
 0 
 
Mild 
Slight itching, not 
really bothersome 
 1 
Slight, but definite 
roughness 
 1 
Slight burning sensation; 
not really bothersome 
 1 
Moderate 
Definite itching 
that is somewhat 
bothersome 
 2 
Definite roughness 
 2 
Definite warm, burning 
that is somewhat 
bothersome 
 2 
Severe 
Intense itching 
that may interrupt 
daily activities 
and/or sleep 
 3 
Marked roughness 
 3 
Hot burning sensation that 
causes definite discomfort 
and may interrupt daily 
activities and sleep 
 3 
Please assess the Presence and Absence of the following: 
Skin Atrophy 
 not present 
 present; specify location: 
Striae 
 not present 
 present; specify location: 
Telangiectasia 
 not present 
 present; specify location: 
Folliculitis 
 not present 
 present; specify location: 
 
 
 
 
 
 
 
 
Appendix D 

 
 
Version 3      11Apr2016 
 
21 
 
Schedule of Assessments 
Procedure 
Screening 
Enrollment 
/ Baseline 
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 
 
 
 
Local Skin Reaction 
  
X 
X 
X 
X 
Investigational Product 
compliance/Diary Review 
 
X 
X 
X 
X 
Patient Satisfaction 
  
  
X 
  
X 
Dermatology Life Quality 
Index 
  
X 
X 
X 
X 
IP dispense/accountability 
  
X 
X 
X 
X 
 
 
 

 
 
Version 3      11Apr2016 
 
22 
 
 
Appendix E 
Subject Diaries 
 
 
 
 
 
 

 
 
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23 
 
 
 
 
 
 
 

 
 
Version 3      11Apr2016 
 
24