A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
Phase: PHASE2
Conditions: Dermatitis, Atopic
Sponsor: Sun Pharmaceutical Industries Limited

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and 
Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis   
Document: Study Protocol 
NCT number: NCT04684485 
Document date: 10 April 2023 

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PRINCIPAL INVESTIGATOR AGREEMENT 
 
I have carefully read and understand the foregoing protocol SCD-044-19-16 “A RANDOMIZED, DOUBLE-
BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SCD-044 IN THE 
TREATMENT OF MODERATE TO SEVERE ATOPIC DERMATITIS” and agree that it contains all the 
necessary information for conducting this study safely. I will conduct this study in strict accordance with this 
protocol, International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), the 
Code of Federal Regulations (CFR) and local regulatory guidelines. I will attempt to complete the study within 
the time designated. 
 
I will ensure that the rights, safety and welfare, of Subjects under my care are protected. I will ensure control of 
the drugs under investigation in this study. 
 
I will provide copies of the protocol and all other study-related information supplied by the Sponsor to all 
personnel responsible to me who participate in the study. I will discuss this information with them to assure that 
they are adequately informed regarding the drug and conduct of the study. 
 
I agree to keep records on all Subject information (case report forms, shipment and drug return forms and all 
other information collected during the study) and drug disposition in accordance with Food and Drug 
Administration (FDA) regulations. 
 
I will not enroll any Subjects into this protocol until IRB approval and Sponsor approval are obtained. 
 
 
 
 
 
 
 
Principal Investigator 
 
Signature, Date 

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Protocol:  SCD-044-19-16 
 
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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALC 
Absolute Lymphocyte Counts 
ALP 
Alkaline Phosphatase 
ALT 
Alanine aminotransferase 
ANC 
Absolute neutrophil count 
ACR 
American College of Rheumatology 
AST 
Aspartate aminotransferase 
ATS 
American Thoracic Society 
ATWS 
Active Treatment Worst Case 
AUC 
Area under the concentration-time curve 
AV block 
Atrioventricular block 
BL 
Baseline 
BP 
Blood pressure 
bpm 
beats per minute 
BSA 
Body Surface Area 
CFR 
Code of Federal Regulations 
Cmax 
Maximum Concentration/Maximum Observed Concentration 
CMH 
Cochran-Mantel-Haenszel 
CNS 
Central Nervous System  
COPD 
Chronic obstructive pulmonary disease 
eCRF 
Electronic Case Report Form 
CRO 
Contract Research Organization 
Ctrough 
lowest concentration reached by a drug before the next dose 
DLQI 
Dermatology Life Quality Index 
DM 
Data Management 
DMARD 
Disease Modifying Anti-rheumatic drug 
EASI 
Eczema Area and Severity Index 
EC 
Ethics Committee 
ECG 
Electrocardiography 
ED 
Early Discontinuation 
EDC 
Electronic Data Capture 
e.g. 
exempli gratia, “for example”, “such as” 
EoS 
End-of-Study 
EOT 
End of Treatment  
EU 
European Union 
EU Ct No. 
European Union Clinical Trial Register number  
FEV 
Forced expiratory volume 
FDA 
Food and Drug Administration 
FVC 
Forced vital capacity 
GCP 
Good Clinical Practice 
GGT 
Gamma glutamyltransferase 
GLP 
Good Laboratory Practice 
HAQ 
Health Assessment Questionnaire 
HBsAg 
Surface antigen of the hepatitis B virus (HBV) 
hCG 
Human Chorionic Gonadotropin 
HEENT 
Head, Eyes, Ears, Nose and Throat 
HIV 
Human immunodeficiency virus 
hr 
Hour 
HR 
Heart rate 
hrs 
Hours 
HDL 
High-density lipoproteins 
ICF 
Informed Consent Form 
IGA 
Investigator Global Assessment 
ICH 
International Conference on Harmonization 
ID 
Identification 
IRB 
Institutional Review Board 
IUD 
Intrauterine Device 
ICH  
International Conference on Harmonization  
IGA 
Investigator’s Global Assessment 
INR 
International Normalized Ratio 
IND 
Investigational New Drug 
IP (IMP) 
Investigational (Medicinal) Product  
IR 
Infrared  

 
 
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Relationship to Study Medication  
The relationship is characterized as:  
x 
Not Related: This applies to any AE that is clearly not related to use of the study drug.  
x 
Possible: This means the association of the AE with the study drug is unknown; however, a 
relationship between drug and event cannot be ruled out.  
x 
Probable: There is a reasonable temporal relationship between the use of the study drug and 
the AE. Based upon the Principal Investigator or designee’s clinical experience, the association 
of the event with the study drug seems likely.  
x 
Definite: The AE occurs following the application of the study drug and it cannot be reasonably 
explained by any known characteristics of the Subject’s clinical state, environmental or toxic 
factors or other modes of therapy administered to the Subject. It disappears or decreases upon 
discontinuation of the study drug and reappears on a re-challenge of the investigational 
product.  
10.2 
Pregnancy 
Female Subjects of childbearing potential must have been using and must agree to continue to use 
accepted methods of birth control, throughout the study. All female Subjects are considered to be of 
childbearing potential unless they are premenarchal, have been surgically sterilized or have been 
postmenopausal for at least 1 year. Tubal ligation is not considered equivalent to female sterilization.  
Women with a history of tubal ligation are still considered females able to become pregnant and must 
complete a pregnancy test. Alternatively, any of the following methods of birth control are acceptable: oral 
or injectable contraceptives, contraceptive patches, 
 (stabilized for at least 3 months), 
(vaginal contraceptive), 
 (contraceptive implant), double barrier methods (e.g. 
condom and spermicide), IUD, tubal ligation, Essure or abstinence with a 2nd acceptable method of birth 
control should the Subject become sexually active.  Prior to study enrollment women of child bearing 
potential must be advised of the importance of avoiding pregnancy during study participation. 
A negative result of a pregnancy test having a minimum sensitivity of at least 50mIU/ml for hCG should be 
obtained from each applicable visit. Pregnancy testing will be performed at applicable study visits and the 
results of all pregnancy tests (positive or negative) will be documented. 
If following initiation of study treatment, it is subsequently discovered that a study Subject is pregnant or 
may have been pregnant at the time of Investigational Product exposure, the Investigational Product will 
be permanently discontinued. The Principal Investigator or designee must immediately notify the CRO of 
this event. 
Protocol-required procedures for study discontinuation and follow-up must be performed on the Subject. 
Other appropriate pregnancy follow-up procedures should be considered if indicated. In addition, the 
Principal Investigator must report to the sponsor follow-up information regarding the course of the 
pregnancy, including perinatal and neonatal outcome. Infants should be followed for a minimum of eight 
weeks after birth.   
10.3 
Serious Adverse Events  
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: 
x 
Death  
x 
A life threatening adverse event; (Note: the term “life-threatening” as used here refers to an event 
in which 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.)  
x 
In-Subject hospitalization or prolongation of existing hospitalization 
(A planned hospitalization for pre-existing condition, or a procedure required by the Clinical 
Investigation Plan, without a serious deterioration in health or if the hospitalization is clearly not 
associated with an AE (e.g., hospitalization due to social / logistic reason) are not to be considered 
as SAEs)  
x 
A persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal 
life functions) 

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of the written informed consent form and any other information to be provided to Subjects. 
Informed consent will be obtained from all Subjects using the following procedure: Subjects must have 
provided IRB approved written informed consent. Prior to initiating screening for the study, Subjects 
will be given the approved ICF describing the study and any risks associated with participation. The 
Subject will be allowed as much time as needed to read and understand the information presented in 
the consent form. Appropriate study personnel will be available to answer any questions the Subject 
might have regarding the study or study-related procedures. If the Subject chooses to participate in the 
study, he or she will be asked to sign and date the consent form and will be provided with a copy for 
his or her records. The ICF must be signed by the Subject before any protocol assessments can be 
undertaken. Each Subject’s signed informed consent must be kept on file by the Principal Investigator. 
11.2 
Institutional Review Board  
Before study initiation, the Principal Investigator must have written and dated approval from the IRB for 
the protocol, consent form, Subject recruitment materials and any other written information to be 
provided to Subjects.  
Any changes to the protocol as well as a change of the Principal Investigator, which is approved by the 
Sponsor, must also be approved by the site’s IRB and documentation of this approval provided to the 
Sponsor/designee. Records of the IRB review and approval of all documents pertaining to this study 
must be kept on file by the Principal Investigator and are subject to inspection during or after completion 
of the study.  All SAEs must also be reported to the IRB. 
Periodic status reports must be submitted to the IRB at least annually, as well as notification of 
completion of the study and a final report within one (1) month of study completion or discontinuation 
or per the local ethics committee requirements. A copy of all reports submitted to the IRB must be sent 
to the Sponsor/designee. 
The Principal Investigator will ensure that an IRB that complies with the requirements set forth in 21 
CFR Part 56 will be responsible for the initial and continuing review and approval of the proposed 
clinical study. 
11.3 
Subject Confidentiality  
The investigator and the sponsor or its designee must adhere to applicable data protection laws and 
regulations. The investigator and the sponsor or its designee are responsible for ensuring that sensitive 
personal information is handled in accordance with local data protection laws (including, but not limited 
to, HIPAA and GDPR). Appropriate consent for collection, use, and disclosure and/or transfer (if 
applicable) of personal information must be obtained in accordance with local data protection laws. 
Participant names will not be supplied to the sponsor or its designee. Only the participant number will 
be recorded in the study database; if the participant's name appears on any other document (eg 
laboratory report), it must be obliterated on the copy of the document to be supplied to the sponsor or 
its designee. Study findings stored on a computer will be stored in accordance with appropriate 
technical and organizational measures as required by local data protection laws. 
The monitor(s), the auditor(s), IRB/IEC, and the regulatory authority(ies), will be granted direct access 
to the Subject’s original medical records for verification of the clinical trial procedures and/or data, 
without violating the confidentiality, to the extent permitted by the applicable laws and regulations and 
that by signing a written informed consent form, the Subject or the Subject’s legally acceptable 
representative is authorizing such access. 
The identifying the Subject will be kept confidential and, to the extent permitted by the applicable laws 
and regulations, will not be made publicly available. If the results of the trial are published, the Subject’s 
identity will remain confidential. 
11.4 
Indemnity/Liability and Insurance 
The Sponsor ensures that suitable clinical study insurance coverage is in place prior to the start of the 
study. An insurance certificate is supplied to the CRO/Investigator as necessary. 

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12. 
DOCUMENTATION  
12.1 
Site Regulatory Documents Required for Initiation  
The following documents will be received by the CRO prior to the initiation of the study:  
1. Completed and signed FDA Form 1572 
2. Current curricula vitae, signed and dated for the Principal Investigator and each Sub-Investigator 
named in the FDA Form 1572 (current within 2 years) 
3. Current medical licenses of the Principal Investigator and Sub-Investigators named in FDA Form 
1572 
4. Documentation of IRB approval of this study protocol, Principal Investigator and informed consent 
form 
5. Current IRB membership list or roster  
6. A copy of the protocol agreement page signed by the Principal Investigator  
7. Non-disclosure Agreements for the Principal Investigator and Sub-Investigators named in FDA 
Form 1572  
8. Financial Disclosure Statement for the Principal Investigator and each Sub-Investigator named in 
FDA Form 1572. 
9. Statement of Non-Debarment 
12.2 
Maintenance and Retention of Records  
It is the responsibility of the Principal Investigator to maintain a comprehensive and centralized filing 
system of all relevant documentation. 
Copies of all pertinent records will be retained by the Principal Investigator for at least two years 
following final approval of the drug and/or notification from the Sponsor. These regulatory documents 
should be retained for a longer period if required by local regulatory authorities. These records include 
documents pertaining to the receipt and return of drug supplies, IRB, informed consent, source 
documents. No documents shall be transferred from the site or destroyed without first notifying the 
Sponsor. If the Principal Investigator withdraws from the study, the records shall be transferred to a 
mutually agreed upon designee. Notice of such transfer will be given in writing to the Sponsor. 
The Principal Investigator is required to prepare and maintain adequate and accurate case histories 
designed to document all observations and other data pertinent to the investigation on each individual 
treated with the Investigational Product or entered as a control in the investigation.   
12.3 
Data Collection and Reporting  
Data for individual Subjects will be collected on source documents. The data management system will 
be Electronic Data Capture (EDC). The Investigator and his/her study site personnel will be responsible 
for transferring data to the electronic Case Report Forms (eCRFs). The Investigator is required to verify 
that all of the requested information is accurately recorded in the eCRFs. All information requested in 
the eCRFs needs to be supplied, including subject identification, date(s), assessment values, etc., and 
any omission or discrepancy will require explanation. All information on eCRFs must be traceable to 
source documents.  
Source documents such as the clinic chart are to be maintained separately from the eCRF in order to 
allow data verification. Because of the potential for errors, inaccuracies and illegibility in transcribing 
data into eCRFs, originals of laboratory and other test results must be kept on file. Source documents 
and copies of test results must be available at all times for inspection by the study monitor. The following 
should also be available for review:  
1. Subject Screening Log – reflecting the reason any Subject screened for the study was found to be 
ineligible 

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12.7 
Audits and Inspections  
During the course of the study and/or after it has been completed, one or more site visits may be 
undertaken by auditors as authorized representatives of the Sponsor. The purpose of the audit is to 
determine whether or not the study is being conducted and monitored in compliance with the protocol, 
recognized GCP guidelines and all applicable regulations. 
Additionally, the study may be inspected by regulatory agencies. These inspections may take place at 
any time during the course of the study and/or after it has been completed.  
The investigators and institutions involved in the clinical trial are to permit clinical trial-related audits 
and regulatory inspections, including provision of direct access to source data and documents. 
THE INVESTIGATOR MUST NOTIFY THE CONTRACT RESEARCH ORGANIZATION and 
SPONSOR PROMPTLY OF ANY INSPECTIONS SCHEDULED BY REGULATORY AUTHORITIES, 
AND PROMPTLY FORWARD COPIES OF INSPECTION REPORTS TO THE SPONSOR. 
12.8 
Modifications to the Protocol  
The procedures defined in the protocol will be carefully reviewed to ensure that all parties involved with 
the study fully understand the protocol. In order to ensure the validity of the data, no violations from the 
protocol, with minimal exceptions, may be made unless the issue is broad enough to warrant revision 
of the protocol. Such revisions must be submitted to and have documented approval from the Sponsor 
and the IRB/regulatory agency, as applicable, prior to implementation.  
The only circumstance in which an amendment may be initiated without prior IRB approval is to 
eliminate apparent immediate hazards to a Subject or Subjects. However, the Principal Investigator 
must notify the Sponsor immediately and the IRB within 5 working days after implementation.  
All protocol violations will be reported on the protocol violation log and included in the study reports. A 
protocol violation is defined as any change, deviation, or departure from the study design or procedures 
of  research project that is NOT approved by the IRB prior to its initiation or implementation, OR 
deviation from standard operating procedures, Good Clinical Practices (GCPs), federal, state or local 
regulations. 
The sponsor will notify the authorities as applicable (in line with country/region requirements) about a 
serious breach of the regulations or of the version of the protocol applicable at the time of the breach. 
A ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a 
participant or the reliability and robustness of the data generated in the clinical trial. 
12.9 
Completion of Study  
The Principal Investigator is required to sign the eCRFs and all other relevant data and records to the 
Contract Research Organization.  
The Principal Investigator is expected to submit a final report to the IRB and the Sponsor within one (1) 
month of study completion or discontinuation. 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IRBs/IECs, the regulatory authorities, and any Contract Research Organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable regulatory 
requirements. 
Study results reporting: 
The Sponsor will provide Clinical Study Report (or its summary) to the regulatory agencies, as 
applicable, in timeframe in line with country requirements.  
For the EU countries: irrespective of the outcome of the clinical trial, the Sponsor will submit a summary 
of the intermediate results, as well final results of the clinical study to the relevant EU clinical study 
database (the Clinical Trials Information System [CTIS] database at https://euclinicaltrials.eu/home) in 
a timely manner. As appropriate, the final study results posting this will be accompanied by a summary 
written in a manner that is understandable to laypersons. 

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12.10 Data Protection in the European Economic Area 
The Sponsor, as Data Controller, ensures that all processing activities involving personal data 
performed in the scope of this Study are compliant with, but not limited to, the requirements set by EU 
General Data Protection Regulation (GDPR 679/2016), its subsequent amendments and any additional 
national laws on Data Protection, recommendations, and guidelines as applicable 
 
The Sponsor will take adequate measures to comply with the applicable rules on the protection of 
personal data, specifically regarding the implementation of the organizational and technical 
arrangements aiming to avoid unauthorised access, disclosure, dissemination, alteration, or loss of 
information and processed personal data. Similarly, measures will be taken to implement and for 
ensuring confidentiality of records and personal data of subjects. 
In case of the occurrence of any data breach, the Sponsor will immediately apply relevant measures to 
mitigate the risks to data of subjects as appropriate in relation to the specific context of the data breach, 
taking into account its source, underlying intentions, possibilities of recovery etc. Any data breach 
presenting risks to the rights and freedoms of data of subjects will be reported to the relevant 
supervisory data protection authority within 72 hours of the Sponsor becoming aware of the data breach   
13. 
REFERENCES  
1. National Eczema Association. Atopic Dermatitis. https://nationaleczema.org/eczema/types-of-
eczema/atopic-dermatitis/. 
2. American Academy of Allergy Asthma & Immunology. Atopic dermatitis: A practice parameter 
update 2012. 
https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20and%20Para
meters/Atopic-dermatitis-2013.pdf. 
3. Hanifin JM and Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol. 1980; 
Suppl. 92: 44-7 
4. Eichenfield LF, et al.  Guidelines of care for the management of atopic dermatitis. J Am Acad 
Dermatol. 2014;70:338-351. 
5. FDA Label of Dupixent. Revised: 06/2020. 
6. FDA Label of Protopic. Revised 11/2011. 
7. FDA Label of Eucrisa. Revised 03/2020. 
8. ClinicalTrials.gov. A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With 
Moderate-to-Severe Atopic Dermatitis (ADVISE). NCT04162769. 
https://clinicaltrials.gov/ct2/show/NCT04162769. 
9. Graham BL, et al. Standardization of spirometry 2019 update. An official American Thoracic 
Society and European Respiratory Society technical statement, PubMed: 31613151. 
10. Quanjer PH, et al. Multi-ethnic reference values for spirometry for the 3–95-yr age range: the 
global lung function 2012 equations. Eur Respir J. 2012;40:1324-1343. 
11. Culver BH, et al. Recommendations for a standardized pulmonary function report: an official 
American Thoracic Society technical statement. Am J Respir Crit Care Med. 2017; 196(11):1463-
1472. 
12. Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) 
Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the 
First International Workshop. Am J Ophthalmol. 2005; 140:509-16. 
13. AHQR. Tool 3F: Orthostatic Vital Sign Measurement. AHRQ Website. 
https://www.ahrq.gov/professionals/systems/hospital/fallpxtoolkit/fallpxtk-tool3f.html. 
14. National Psoriasis Foundation. Just looking for the Topical Steroids Potency Chart? 
https://www.psoriasis.org/about-psoriasis/treatments/topicals/steroids/potency-chart.  

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Handprint method (to determine % BSA affected and extent of involvement for EASI): 
 
To estimate the % BSA Affected and extent of involvement for EASI, the investigator should use the 
handprint method of approximation: the patient’s handprint (palm and fingers together) represents 
approximately one percent (1%) of his/her BSA. 
 
The total number of handprints for each body region of head and neck, upper limbs, trunk (including axillae 
and groin) and lower limbs (including buttocks) equals: 10, 20, 30, and 40, respectively.  
 
The % BSA affected by atopic dermatitis is the percent total of affected areas for all four regions of the 
body. 
 
Body region 
Total number of handprints in 
body region 
Surface area of body region 
equivalent to one handprint 
Head and neck 
10 
10% 
Upper limbs 
20 
5% 
Trunk (includes axillae and groin) 
30 
3.33% 
Lower limbs (includes buttocks) 
40 
2.5% 
 
 
Note: The EASI will exclude scalp, palms, and soles from the assessment/scoring.

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APPENDIX III: PATIENT ORIENTED ECZEMA MEASURE (POEM) EXAMPLE 
 
Please circle one response for each of the seven questions below about your eczema. Please leave blank any 
questions you feel unable to answer.  
 
1. Over the last week, on how many days has your skin been itchy because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
2. Over the last week, on how many nights has your sleep been disturbed because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
3. Over the last week, on how many days has your skin been bleeding because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
4. Over the last week, on how many days has your skin been weeping or oozing clear fluid because of your 
eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
5. Over the last week, on how many days has your skin been cracked because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
6. Over the last week, on how many days has your skin been flaking off because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
7. Over the last week, on how many days has your skin felt dry or rough because of your eczema?  
 
No days  
1-2 days  
3-4 days 
 5-6 days  
Every day 
 
 
 
Total POEM Score (Maximum 28): ________ 

 
 
APPENDIX IV: DERMATOLOGY LIFE QUALITY INDEX (DLQI) EXAMPLE 
The aim of this questionnaire is to measure how much your skin problem has affected your life over the past 
week.  Please check ;
one box for each question. 
 
1 
Over the last week, how itchy, sore, painful 
or stinging has your skin been? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
2 
Over the last week, how embarrassed or 
self-conscious have you been because of 
your skin? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
3 
Over the last week, how much has your skin 
interfered with you going shopping or 
looking after your home or garden? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
4 
Over the last week, how much has your skin 
influenced the clothes you wear? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
5 
Over the last week, how much has your skin 
affected any social or leisure activities? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
6 
Over the last week, how much has your skin 
made it difficult for you to do any sport? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
7 
Over the last week, has your skin prevented 
you from working or studying? 
Yes 
No 
 
 
 
Not relevant 
 
 
 
If "No", over the last week how much has 
your skin been a problem at work or 
studying? 
A lot 
A little 
Not at all 
 
 
 
 
 
8 
Over the last week, how much has your skin 
created problems with your partner or any 
of your close friends or relatives? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
9 
Over the last week, how much has your skin 
caused any sexual difficulties? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
10 Over the last week, how much of a problem 
has the treatment for your skin been, for 
example by making your home messy, or by 
taking up time? 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 

 
 
How to use EASI: 
1. Select a body region 
 
2. Assess the extent of eczema in that body region 
 
Each body region has potentially 100% involvement. Using the table below, give each respective 
body region a score of between 0 and 6 based on the percentage involvement. Precise 
measurements are not required. 
 
To aid in your body region grading you can use the diagrams below. 
 
 
3. Assess the severity of each of the four signs in that body region: erythema, edema/papulation, 
excoriation, and lichenification 
 
Grade the severity of each sign on a scale of 0 to 3. 
 
- Take an average of the severity across the involved region. 
- Half points (1.5 and 2.5) may be used. 0.5 is not permitted – if a sign is present it should be at least mild 
(1) 
- Palpation may be useful in assessing edema/papulation as well as lichenification 
 
To aid your severity grading, a photographic atlas of suggested categories is available below. 

 
 
 
Remember: Include only inflamed areas in your assessment; do not include xerosis (dryness), 
ichthyosis, keratosis pilaris, urticaria, infection (unless there is underlying eczema), or post inflammatory 
pigmentation changes. 
 
 
 
 
 

 
 
APPENDIX VI: PATIENT GLOBAL IMPRESSION OF SEVERITY (PGIS) EXAMPLE 
 
Please choose the response below that best describes the severity of your atopic dermatitis over the past 
week. 
 
 None  
 Mild  
 Moderate  
 Severe  
 
 
 
 

 
 
 
APPENDIX VII: PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) EXAMPLE 
 
Please choose the response below that best describes the overall change in your atopic dermatitis 
since you started taking the study medication: 
Please check ;
one box only 
 
 
Much better 
 
 
A little better 
 
 
No Change 
 
 
A little worse 
 
 
Much Worse 
 
 
 

 
 
APPENDIX VIIIa: PEAK PRURITUSNUMERIC RATING SCALE (PP-NRS) EXAMPLE 
 
Severity of Pruritus 
 
On a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable”, how would you rate 
your itch at the worst moment during the previous 24 hours?  
 
 
 
 
 
 
 

 
 
APPENDIX VIIIb: FREQUENCY OF ITCHING DUE TO ATOPIC DERMATITIS EXAMPLE 
 
Frequency of Pruritus 
 
Select the number that best describes frequency of itching due to atopic dermatitis over the past 24 hours 
(check one number only). 
 
 
 
 
 

Subjective symptoms (C)
Note: Please ensure that the line is 100 mm in length after printing the source document and 
measuring the distance
Instructions for the subject
Itch:
Sleeplessness:
Sleeplessness
No sleeplessness
Worst imaginable itch
No itch
0
10
0
10