An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
Phase: PHASE4
Conditions: Psoriasis
Sponsor: University of Alabama at Birmingham

 
An investigator initiated open label study evaluating the 
efficacy and tolerability of application of Metaderm product for 
the treatment of psoriasis 
 
 
     Study Protocol & Statistical Analysis Plan  
 
 
 
 
   
 
 
 
 
        NCT03597620 
 
 
 
 
 
 
 
 
 
 
 
    November 5, 2018 
 
 
 
 
Boni Elewski, M.D., Principal Investigator 
 
 
  University of Alabama at Birmingham 
 
 
 
 
Birmingham, AL 35294 
 
 

An investigator initiated open label study evaluating the efficacy and tolerability of application of 
Metaderm product for the treatment of psoriasis 
PI: Boni Elewski, MD 
Sponsor : Procter & Gamble  
Introduction:  
Psoriasis vulgaris is a common inflammatory condition of the skin that results in well-demarcated, scaly, 
erythematous, itchy plaques. In the United States, psoriasis remains a common, immune-mediated 
disease, affecting 7.4 million adults. (1) Often topical prescription medications are used as first line 
treatment for moderate psoriasis. Some topical medications have side effects and risk with long time 
use, thus not ideal for extensive and indefinite amount of time. Conversely, over- the-counter emollient 
treatments are readily available, safe and potentially efficacious.  This study is design to test the safety 
and efficacy of topical application of the Metaderm product cream. The Metaderm cream is non-
prescription, natural product.  
Study objectives  
Primary objective  
 The Primary efficacy and end point will be the mean percentage change in the product of sPGA and BSA 
(PGAxBSA) from baseline to week 12. The PGA x BSA is an assessment tools used to calculating disease 
severity and maybe more likely to differentiate among people with less disease severity (Walsh) 
Secondary objective  
The secondary efficacy and end point will be the percentage improvement in DLQI  
 
Study Design 
Study Outline 
This is an open-label pilot study aimed at evaluating the efficacy and safety of treating psoriasis using 
the Metaderm product.  The inclusion and exclusion criteria as listed below. Study designed into 3 
subgroups:  
1) 5 patients with plaque psoriasis 3-10% BSA 
2) 5 patients with stable dose of biologic treatment and have plaque psoriasis with 3-10% 
BSA  
3) 5 patients with scalp psoriasis  
 
Number of subjects: 
Total of 15 eligible patients will be enrolled. Patients will be treated for duration of 12 weeks. During the 
treatment phase patients will be evaluated every 4 weeks. All patients will be treated with the active 
medication, there will be no placebo arm in the study.  
 

Visit Schedule  
Screening Period 
Patient eligibility will be determined within 28 days prior to enrollment in the study. Subjects who meet 
the inclusion and exclusion criteria may proceed to the baseline visit.  
Study Visits  
Subjects will report to the investigational site for disease and safety assessments every 4 weeks for total 
of 12 Weeks. Patients will have photos taken of 1-3 target lesions at baseline , W4 , W8, and W12 . 
Patient will complete the Itch Severity Scale (ISS, Visual Analogue Scale (VAS) and Dermatology Quality 
of Life Index (DLQI) questionnaires at every visit. Patient will have a Psoriasis Area and Severity Index 
(PASI), Static Physicians Global Assessment (sPGA) and Body Surface Area (BSA) evaluation at every visit.   
Dosing schedule  
 15 eligible patients will be enrolled. Patient will be treated for 12 weeks.  There will be a total of five 
visits: screening, baseline, w4, w8 and w12.  Metaderm cream will be applied topically twice a day to all 
active lesions. The metaderm scalp spray will be applied daily to the affected areas on the scalp. Patients 
will be provided with metaderm cleanser, can be use daily.   For the subgroup for scalp psoriasis, patient 
will use the shampoo Head & Shoulders formula with 1% Pyrithione Zinc as the active ingredient 
Discontinuation of the Study 
The study may be discontinued at the discretion of the investigator at any time without replacement 
STUDY ENTRY CRITERIA 
Patients will be recruited from the university hospital clinic as well as resident’s continuity clinics 
Inclusion Criteria for patients with plaque psoriasis 3-10% BSA 
Subjects must satisfy the following criteria to be enrolled in the study: 
1. Must be in general good health (except for disease under study) as judged by the Investigator, 
based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The 
definition of good health means a subject does not have uncontrolled significant co-morbid 
conditions).   
2. Patients 18 and older 
3.  Give written informed consent prior to any study procedures being conducted, and candidates 
will authorize the release and use of protected health information (PHI) 
4. Be willing and consent to having photos taken of their skin 
5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline 

6. Plaque psoriasis involving at least 3-10% of the patient’s body surface area 
7. Must have discontinued all systemic therapies for the treatment of psoriasis or psoriatic arthritis 
at least 4 weeks or 5 half-lives, and biologics 6 months) prior to baseline visit 
8. Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior 
to baseline visit 
9. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 
4 weeks prior to baseline. 
10. Subjects must be in good general health without significant uncontrolled comorbidities, other 
than psoriasis, as determined by the investigator based on exam findings, medical history, and 
clinical laboratories. Patients with stable mild renal insufficiency are eligible for enrolling in this 
trial. 
11. Females of childbearing potential must use an approved birth control method while receiving 
treatment and for 28 days following the investigational product and there must be a documented 
negative pregnancy tests prior to initiating treatment. Approved birth control methods include 
hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring), intrauterine 
device, tubal ligation (tying your tubes), partners vasectomy, or male or female condoms that are 
not made of natural materials PLUS a diaphragm with spermicide, cervical cap with spermicide, 
or a contraceptive sponge with spermicide. Females not of child bearing potential are defined as 
being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral 
oophorectomy and/or hysterectomy). 
Inclusion Criteria with stable dose of biologic treatment and have plaque psoriasis 3-10 %BSA 
Subjects must satisfy the following criteria to be enrolled in the study: 
1. Must be in general good health (except for disease under study) as judged by the Investigator, 
based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The 
definition of good health means a subject does not have uncontrolled significant co-morbid 
conditions).   
2. Patients 18 and older 
3.  Give written informed consent prior to any study procedures being conducted, and candidates 
will authorize the release and use of protected health information (PHI) 
4. Be willing and consent to having photos taken of their skin 

5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline 
6. Stable dose of biologic therapy for the last 6 months prior to screening visit   
7. Plaque psoriasis involving at least 3-10% of the patient’s body surface area 
8. Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior 
to baseline visit 
9. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 
4 weeks prior to baseline. 
10. Subjects must be in good general health without significant uncontrolled comorbidities, other 
than psoriasis, as determined by the investigator based on exam findings, medical history, and 
clinical laboratories. Patients with stable mild renal insufficiency are eligible for enrolling in this 
trial. 
11. Females of childbearing potential must use an approved birth control method while receiving 
treatment and for 28 days following the investigational product and there must be a documented 
negative pregnancy tests prior to initiating treatment. Approved birth control methods include 
hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring), intrauterine 
device, tubal ligation (tying your tubes), partners vasectomy, or male or female condoms that are 
not made of natural materials PLUS a diaphragm with spermicide, cervical cap with spermicide, 
or a contraceptive sponge with spermicide. Females not of child bearing potential are defined as 
being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral 
oophorectomy and/or hysterectomy). 
Inclusion Criteria for patients with scalp psoriasis  
Subjects must satisfy the following criteria to be enrolled in the study: 
1. Must be in general good health (except for disease under study) as judged by the Investigator, 
based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The 
definition of good health means a subject does not have uncontrolled significant co-morbid 
conditions).   
2. Patients 18 and older 
3.  Give written informed consent prior to any study procedures being conducted, and candidates 
will authorize the release and use of protected health information (PHI) 

4. Be willing and consent to having photos taken of their skin 
5. Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline 
6. Plaque psoriasis involving the scalp 
7. Body plaque psoriasis cannot exceed 10 %BSA  
8. Must have discontinued all systemic therapies for the treatment of psoriasis or psoriatic arthritis 
at least 4 weeks or 5 half-lives, and biologics 6 months) prior to baseline visit 
9. Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior 
to baseline visit 
10. Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 
4 weeks prior to baseline. 
11. Subjects must be in good general health without significant uncontrolled comorbidities, other 
than psoriasis, as determined by the investigator based on exam findings, medical history, and 
clinical laboratories. Patients with stable mild renal insufficiency are eligible for enrolling in this 
trial. 
12. Females of childbearing potential must use an approved birth control method while receiving 
treatment and for 28 days following the investigational product and there must be a documented 
negative pregnancy tests prior to initiating treatment. Approved birth control methods include 
hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring), intrauterine 
device, tubal ligation (tying your tubes), partners vasectomy, or male or female condoms that are 
not made of natural materials PLUS a diaphragm with spermicide, cervical cap with spermicide, 
or a contraceptive sponge with spermicide. Females not of child bearing potential are defined as 
being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral 
oophorectomy and/or hysterectomy). 
Exclusion Criteria 
The presence of any of the following will exclude a subject from enrollment: 
13. Other than disease under study, any clinically significant (as determined by the Investigator) 
cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, 
immunologic disease, or other major disease that is currently uncontrolled. 

14. Any condition, including the presence of laboratory abnormalities, which would place the subject 
at unacceptable risk if he/she were to participate in the study. 
15. Prior history of suicide attempt at any time in the subject’s life time prior to screening or 
randomization, or major psychiatric illness requiring hospitalization within the last 3 years. 
16. Pregnant or breast feeding.  
17. Active substance abuse or a history of substance abuse within 6 months prior to Screening. 
18. Use of any investigational drug within 4 weeks prior to randomization, or 
5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer). 
19. Prior treatment with the investigational product 
20. Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or 
history of noncompliance) 
21. Any other dermatologic conditions that prohibit or confound the ability of the investigator to 
interpret skin and/or nail exam findings. 
22. Patients who will be unable to avoid the use of systemic steroids, excluding intranasal or inhaled 
steroids that will be permitted, for the duration of the trial 
STUDY PROCEDURES & TREATMENT PLAN GUIDELINES 
Informed Consent: 
A written, signed informed consent form (ICF) and written authorization to release and use PHI, will be 
obtained prior to performing any tests or evaluations under this protocol. Patients will have the option 
to ask questions and will be given at least 24 hours to review the ICF before signing.   Patients may 
request the 24 hour review to be waived due to work or travel constraints.  
See Protocol Flowchart for detailed timing of tests and evaluations.   
General Concomitant Therapy: 
Subjects should advise the investigator if they start taking any new medications, including over the 
counter and complementary and alternative medications. 
Concomitant Therapy 
Concomitant medications for psoriasis will not be permitted 
SAFETY PLAN 
Clinical Safety Assessments 

The following clinical safety assessments will be performed:  (See study flowchart) 
 
Physical examinations 
 
Vital signs (temperature, heart rate, blood pressure, and weight) 
 
Monitoring for adverse events 
 
Monitoring for concomitant therapy 
Laboratory Safety Assessments 
The following laboratory tests will be performed at screening, baseline: 
 
Urine pregnancy test, if applicable. 
 
Test / Evaluation 
Screening 
 
Visit 1 
W k 0 
 Visit 2 
Wk 4 
Visit 3 
Wk 8 
Visit 4 
Wk 12 
Informed Consent 
X 
 
 
 
 
Inclusion/exclusion criteria reviewed  
X 
X 
 
 
 
Medical History 
X 
  
  
  
  
Concomitant medications  
X 
X 
X 
X 
X 
Physical Exam 
X 
 
  
  
  
Vital Signs 
X 
X 
X 
X 
X 
Urine pregnancy test 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Photos of Target lesions 
x 
X 
x 
x 
X 
PASI 
x 
X 
x 
x 
x 
BSA 
x 
X 
x 
x 
x 
sPGA 
x 
x 
x 
x 
x 
ISS  
X 
X 
X 
X 
X 
PSSI 
X 
X 
X 
X 
X 
VAS 
X 
X 
X 
X 
X 
DLQI 
X 
X 
X 
X 
X 
IP dispensing  
X 
X 
X 
X 
IP accountability  
X 
X 
X 

 
SAFETY REPORTING 
Adverse Event 
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence occurring at any 
dose that may appear or worsen in a subject during the course of a study. It may be a new intercurrent 
illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject’s 
health, including laboratory test values (as specified by the criteria below), regardless of etiology. Any 
medical condition that was present prior to study treatment and that remains unchanged or improved 
should not be recorded as an AE. If there is a worsening of that medical condition this should be 
considered an AE. A diagnosis or syndrome should be recorded on the AE page of the Case Report Form 
rather than the individual signs or symptoms of the diagnosis or syndrome. 
All AEs will be recorded by the Investigator(s) from the time of signing the informed consent through the 
end of the designated follow-up period. 
Serious adverse event 
A serious adverse event (SAE) is any AE which: 
 
Results in death 
 
Is life-threatening (i.e., in the opinion of the Investigator(s) the subject is at immediate risk 
of death from the AE) 
 
Requires inpatient hospitalization or prolongation of existing hospitalization 
 
Results in persistent or significant disability/incapacity (a substantial disruption of the 
subject’s ability to conduct normal life functions) 
 
Is a congenital anomaly/birth defect 
 
Constitutes an important medical event 
Important medical events are defined as those occurrences that may not be immediately life 
threatening or result in death, hospitalization, or disability, but may jeopardize the subject or require 
medical or surgical intervention to prevent one of the other outcomes listed above.  Medical and 
scientific judgment should be exercised in deciding whether such an AE should be considered serious. 
Events not considered to be SAEs are hospitalizations which: were planned before entry into the clinical 
study; are for elective treatment of a condition unrelated to the studied indication or its treatment; 
occur on an emergency outpatient basis and do not result in admission (unless fulfilling other criteria 
above); are part of the normal treatment or monitoring of the studied indication and are not associated 
with any deterioration in condition. 
If an AE is considered serious, both the AE pages of the CRF and the SAE Report Form must be 
completed. 
For each SAE, the Investigator(s) will provide information on severity, start and stop dates, relationship 
to study drug, action taken regarding study drug, and outcome. 
Classification of severity 

For both AEs and SAEs, the investigator(s) must assess the severity of the event. The AEs will be 
evaluated for severity according to the following scale: 
Grade 1 = Mild 
Grade 2 = Moderate 
Grade 3 = Severe 
Classification of Relationship/Causality of adverse events (SAE/AE) to study drug 
The Investigator(s) must determine the relationship between the administration of study drug and the 
occurrence of an AE/SAE as Not Suspected or Suspected as defined below: 
Not suspected: 
The temporal relationship of the adverse event to study drug 
administration makes a causal relationship unlikely or remote, or 
other medications, therapeutic interventions, or underlying 
conditions provide a sufficient explanation for the observed event 
Suspected: 
The temporal relationship of the adverse event to study drug 
administration makes a causal relationship possible, and other 
medications, therapeutic interventions, or underlying conditions do 
not provide a sufficient explanation for the observed event. 
Immediate reporting of serious adverse events 
Any AE that meets the any criterion for a SAE requires the completion of an SAE Report Form in addition 
to being recorded on the AE pages of the CRF.  The Investigator(s) is required to ensure that the data on 
these forms is accurate and consistent.  This applies to all SAEs, regardless of relationship to study drug, 
that occur during the study, those made known to the Investigator(s) within 30 days after a subject’s last 
dose of study drug, and those made known to the investigator(s) at anytime that are suspected of being 
related to study drug. 
The SAE must be reported immediately (i.e., within 24 hours of the Investigators’ knowledge of the 
event) 
The Investigator(s) is responsible for informing the Institutional Review Board/Ethics Committee 
(IRB/IEC) of the SAE and providing them with all relevant initial and follow-up information about the 
event. The Investigator(s) must keep copies of all SAE information, including correspondence with 
Celgene and the IRB/IEC, on file.  All SAEs that have not resolved upon discontinuation of the subject’s 
participation in the study must be followed until either the event resolves completely, 
stabilizes/resolves with sequelae, or returns to baseline (if a baseline value is available). 
 Citations  
1. Rachakonda, Tara D. et al. Psoriasis prevalence among adults in the United States. Journal of the 
American Academy of Dermatology , Volume 70 , Issue 3 , 512 - 516 
2. Walsh JA, McFadden M, Woodcock J, et al. Product of the Physician Global 
Assessment and body surface area: a simple static measure of psoriasis severity in 
a longitudinal cohort. J Am Acad Dermatol. 2013;69(6):931-937.