Clinical trial NCT03832010
Conditions: Atopic Dermatitis Eczema
Keywords: Topical steroid Crisaborole Topical calcineurin inhibitor
Sponsor: Johns Hopkins University
Start date: 2019-12-17; Completion date: 2024-02-16
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.

Detailed description:
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.

Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.

Arms: arm 1: Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema. arm 2: Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema. arm 3: Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Interventions: intervention 1: Crisaborole intervention 2: Hydrocortisone Ointment intervention 3: Triamcinolone ointment intervention 4: Aquaphor
Intervention descriptions: intervention 1: Participants will be instructed to apply crisaborole to affected areas with eczema. intervention 2: Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin. intervention 3: Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin. intervention 4: Participants will be instructed to moisturize all over the body with Aquaphor.

Protocol documents:
Prot_SAP_000.pdf: 
Steroid-reducing Effects of Crisaborole 
    
NCT03832010
9/18/2020


Date: ____September 18, 2020________________ 
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
Page 1 of 8 
JHM IRB - eForm A – Protocol 
•
Use the section headings to write the JHM IRB eForm A, inserting the appropriate material
in each. If a section is not applicable, leave heading in and insert N/A.
•
When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at
the top of JHM IRB eForm A.
*************************************************************************************************** 
1.
Abstract
a. Provide no more than a one page research abstract briefly stating the problem, the research
hypothesis, and the importance of the research.
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. 
Crisaborole is the newest topical prescription agent approved for treatment of AD in patients aged 2 
and older. Crisaborole is a phosphodiesterase-4 inhibitor, while existing topical options for AD 
include topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs). Side effects 
associated with TCS as well as steroid phobia limits their use by patients and especially their 
parents. The black box warning associated with TCIs makes these agents less than ideal as a steroid-
reducing option. We propose that crisaborole reduces TCS usage in patients with AD. Evidence to 
support this hypothesis would greatly benefit AD patients, their parents, and their providers who are 
seeking a new TCS-reducing option in the chronic management of AD. 
2.
Objectives (include all primary and secondary objectives)
The primary objective is to demonstrate that crisaborole reduces topical steroid use in 
patients with AD. Control group is expected to have greater use of TCS compared to vehicle and 
crisaborole groups. Vehicle group is expected to have greater use of TCS compared to crisaborole 
group. 
The secondary objective is to demonstrate that patients with AD who use crisaborole in 
conjunction with TCS and Aquaphor will have greater improvement in AD and quality of life, 
compared with vehicle and control groups.  
3.
Background (briefly describe pre-clinical and clinical data, current experience with procedures,
drug or device, and any other relevant information to justify the research)
Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. 
Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active 
inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-
adrenal axis suppression (Eichenfield 2014). Steroid phobia and misunderstanding often lead to 
poor compliance and inadequate disease control (Patel 2017). Topical calcineurin inhibitors (TCIs) 
are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face 
and skin folds. However, they are associated with burning reactions and come with black box 
warnings (Eichenfield 2014). 
Crisaborole (Eucrisa, manufactured by Pfizer), the newest topical prescription option for AD, 
is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild 
to moderate AD (Paller 2016). Given the good tolerability and favorable safety profile, crisaborole 
makes for an excellent alternative topical option to its predecessors. However, corresponding data 
are lacking. It would be of great interest to patients, patients’ families and providers if crisaborole 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 2 of 8 
 
can be shown to reduce the amount of TCS necessary for control of AD. We therefore propose a 
proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing 
agent. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
 
 
We propose a proof-of-concept study featuring a randomized, controlled, double-blind 
prospective design to be conducted at a single academic center. The study will include 60 children. 
Patients of pediatric dermatologists at Johns Hopkins will be recruited for this study. Informed 
consent will be obtained from parents/guardians.  
 
 
If patients are already using TCIs, they will not be excluded from the study. However, they 
must discontinue TCI use for a wash out period of 2 weeks prior to start of study and will be 
instructed to not use TCIs during the study period. If patients experience local complications of AD 
such as secondary skin infections, they will not be removed from the study but rather be treated for 
the infection according to standard of care by their pediatric dermatologist. 
 
 
Day 0 corresponds to day of enrollment. Baseline photographs will be obtained (without 
showing the face or other identifying features). Baseline SCORAD scores (SCORing Atopic 
Dermatitis [1993]) and pruritus Numerical Rating Scale scores (NRS [Phan 2012]) will be obtained 
for all enrolled children in the study on Day 0. Evaluation will be performed by a blinded clinician. 
Quality of life will also be evaluated using Children’s Dermatology Life Quality Index (CDLQI 
[Lewis-Jones 1995]) or Dermatology Life Quality Index (DLQI [Finlay 1994]), depending on 
patient age, and DFI (Dermatitis Family Impact Questionnaire [Lawson 1998]) at baseline. Patients’ 
guardians will also be provided with a diary, with which they will keep track of how often they 
apply each topical agent. 
 
 
Children will be randomly assigned to crisaborole group (crisaborole [blinded] and TCS 
plus Aquaphor), vehicle group (vehicle [blinded] and TCS plus Aquaphor), or control group 
(Aquaphor [blinded] and TCS plus Aquaphor). Parents and children will be blinded with regard to 
their assignments. 
 
 
In the crisaborole group, the parents will be provided with crisaborole (with unidentifiable 
packaging) with refills as needed. As for TCS, triamcinolone acetonide 0.1% ointment and 
hydrocortisone 2.5% ointment will be provided, with refills as needed. Aquaphor is to be applied 
for maintenance. Crisaborole will be used as the first-line agent for AD lesions. TCS will be used as 
the second-line agent for AD lesions. See Table 1. 
 
 
In the vehicle group, parents will be provided vehicle (non-medicated ointment) with 
unidentifiable packaging, with refills as needed. They will also have triamcinolone acetonide 0.1% 
ointment and hydrocortisone 2.5% ointment provided, with refills as needed. They will be provided 
identical instructions to the crisaborole group with regard to usage of the vehicle and TCS. See 
Table 1. 
 
 
In the control group, parent(s) will be provided control (Aquaphor) in unidentifiable 
packaging, with refills as needed. They will also be provided triamcinolone acetonide 0.1% 
ointment and hydrocortisone 2.5% ointment, with refills as needed. They will be given identical 
instructions to the crisaborole and vehicle groups with regard to usage of TCS. 
 
Severity of affected area 
Instruction for patient and parents 
Clear (no scratching, no redness, no raised skin) 
Apply Aquaphor twice daily.  
Mild (occasional scratching, mild redness, slightly 
Apply crisaborole* twice daily as needed until 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 3 of 8 
 
raised skin) 
improved from mild to clear. 
Moderate (frequent scratching, significant redness, 
significantly raised skin) 
Apply TCS** twice daily as needed until improved 
from moderate to mild. 
Table 1. *Crisaborole is replaced by vehicle in the vehicle group and by Aquaphor in the control group. **Low-potency 
TCS, hydrocortisone 2.5% ointment, is to be used for moderate AD lesions on sensitive areas such as face, axillae, 
groin. Mid-potency TCS, triamcinolone acetonide 0.1% ointment, is to be used for moderate AD lesions elsewhere on 
the body. 
 
 
1 week after the initial visit and study enrollment, parent(s)/guardian(s) of the patient will 
receive a phone call confirming that they understand the instructions for usage of topicals. 
 
For patients using TCI at baseline, day 0 will be after patients have undergone a 2 week wash 
out period from TCI. 
 
30 days counted from Day 0 (D30 +up to 10 days depending on patient and family’s scheduling 
convenience), a blinded clinician will repeat the assessments of AD severity, pruritus, and quality of 
life using EASI, pruritus NRS, CDLQI or DLQI, and DFI. Parents will be instructed to bring all 
vehicle, crisaborole, and TCS tubes that they have used during the study period. The remaining 
amount will be weighed and the grams of product will be recorded. Their diaries will also be 
collected. The number of refills requested for TCS and crisaborole/vehicle will be recorded. 
Photographs will be obtained. 
 
The same protocol as the D30 visit will be conducted at 90 days (+up to 10 days) counted from 
Day 0. 
 
Routine care for AD consists of regular moisturizer use (such as Aquaphor) and TCS 
application for mild to moderately affected areas. Use of crisaborole for mild to moderate AD 
lesions is also routine AD care. 
In order to minimize the need for research-only in-person visits, telemedicine visits may be 
substituted for in person clinical trial visits or portions of clinical trial visits where determined to be 
appropriate and where determined by the investigator not to increase the participants risks. Prior to 
initiating telemedicine for study visits the study team will explain to the participant, what a 
telemedicine visit entails and confirm that the study participant is in agreement and able to proceed 
with this method. Telemedicine acknowledgement will be obtained in accordance with the 
Guidance for Use of Telemedicine in Research. In the event telemedicine is not deemed feasible, 
the study visit will proceed as an in-person visit. Telemedicine visits will be conducted using 
HIPAA compliant method approved by the Health System and within licensing restrictions. 
 
b. Study duration and number of study visits required of research participants. 
 
Study duration will be 90 days from day of enrollment (+2 weeks if wash out period from TCI is 
required). 3 study visits (Day 0, day 30, day 90) will be required of research participants. 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Participants, their parents, and clinicians performing assessments will be blinded during this study. 
The participant’s assignment to control versus vehicle versus crisaborole group will be the subject 
of blinding. Participants will be provided with unlabeled tubes of a topical agent which may be 
Aquaphor, vehicle, versus crisaborole. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
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Regular use of a bland moisturizer such as Aquaphor and TCS / TCI use for inflamed areas of AD 
are standard of care for AD management. However, patients who are currently using TCI such as 
tacrolimus or pimecrolimus will have to discontinue use of these agents in a 2 week wash-out 
period. This is because in assessing whether crisaborole reduces TCS use, participants should not be 
applying an additional non-steroid topical medication such as TCIs. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
We will have a control group where participants will be using TCS, Aquaphor, and a blinded 
control (Aquaphor) to manage their AD. We will also have a vehicle group where participants will 
be using TCS, Aquaphor, and vehicle (for crisaborole) to manage their AD. While these groups are 
considered placebo / non-treatment groups since crisaborole is not used, the treatment regimen still 
falls within standard of care for AD which consists of regular moisturizer use (such as Aquaphor) 
and TCS use for affected areas. 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants will be removed if they are unable to follow up for return visits as required in the study 
or if they are unable to follow the instructions provided at the start of the study. If a participant 
becomes pregnant they will be removed from the study. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
When the study ends or if a participant is prematurely removed from the study, the participant 
should continue to follow up with their regular dermatologist and manage their AD as instructed by 
their dermatologist. 
 
5. 
Inclusion/Exclusion Criteria 
 
Inclusion criteria:   
1. Children aged 2 or older (<18).  
2. Diagnosed with atopic dermatitis.  
3. At baseline, AD is mild to moderate (score of 2 [mild] to 3 [moderate]) on the Investigator’s 
Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).  
  
Exclusion criteria:  
1. Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical 
steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment]).  
2. At baseline, AD is severe (score of 4 [severe] on the IGA scale).  
3. Medical problems which interfere with completion of protocols in this study.  
4. Pregnant or lactating females. (Females who have experienced menarche will be required to 
take a urine pregnancy test.) 
5. Participant is enrolled in another research study. 
6. Participant or their guardian(s) are unable to follow instructions as required in this study. 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Crisaborole is chosen because it is the newest non-steroid FDA-approved prescription topical 
medication for treatment of mild to moderate AD in children 2 years of age and older. The FDA-
approved dosage is application of a thin layer twice daily to affected areas.  
 
Crisaborole vehicle is chosen because this contains only the inactive ingredients found in 
crisaborole, to serve as placebo. 
 
Aquaphor is chosen because this is a skin moisturizer which is routinely used by patients with AD. 
 
Hydrocortisone and triamcinolone are chosen because these are commonly prescribed topical 
steroids for treatment of mild to moderate AD in children 2 years of age and older. Hydrocortisone 
is a low-potency topical steroid, and triamcinolone is a mid-potency topical steroid. The FDA-
approved dosage for hydrocortisone and triamcinolone is application of a thin layer twice daily to 
affected areas. 
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
 
N/A. 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
N/A. 
 
7. 
Study Statistics 
a. Primary outcome variable. 
 
Primary outcome variable is quantity of TCS use. TCS use will be quantified in number of refills 
requested, amount of medication remaining by weight (D90 compared with D0 and D30), and 
frequency based on usage diaries completed by participants and or their parents. 
 
b. Secondary outcome variables. 
 
Secondary outcome variables include improvement in AD as measured in severity, pruritus, and 
quality of life (SCORAD, pruritus NRS, CDLQI/DLQI, DFI), recorded over the duration of the 
study (D0, D30, D90). A blinded investigator will review photographs obtained at Day 0, 30, 90 to 
determine whether AD has improved, worsened, or stayed the same during the study. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
This is a proof-of-concept study and therefore the sample size is small (n=60 total, 20 participants in 
each group). 
 
d. Early stopping rules. 
 
N/A. This study poses minimal risks to participants. 
 
8. 
Risks 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
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Version 3 Dated:   06/2007 
 
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a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
Crisaborole is associated with application site pain in 4% of patients. Hypersensitivity reactions and 
urticaria secondary to crisaborole occur in less than 1% of patients (UpToDate, crisaborole).  
 
Adverse reactions to TCS include (frequency not defined for the following): localized burning, 
acneiform eruption, allergic contact dermatitis, atrophic striae, folliculitis, hypertrichosis, 
hypopigmentation, maceration of the skin, miliaria, perioral dermatitis, pruritus, secondary skin 
infection, skin atrophy, xeroderma, HPA-axis suppression, hyperglycemia, hypokalemia, local 
irritation (UpToDate, triamcinolone).  
 
There is risk of allergic reaction or irritation from vehicle and Aquaphor products used in the study. 
 
In females who have experienced menarche, urine pregnancy testing may be stressful and 
inconvenient for the participant and guardian. There is risk of participant and their guardian finding 
out that the participant is pregnant. 
 
Participants may find photographs and skin exams stressful. There is risk of loss of confidentiality 
with regard to the photographs. No identifiable features will be included in photographs. 
 
Participants and their guardians may experience fatigue or boredom from questionnaires. 
 
b. Steps taken to minimize the risks. 
 
Risks are minimized through our inclusion and exclusion criteria. Only participants with mild to 
moderate AD will be included, such that limited amounts of topical medication (crisaborole, TCS, 
vehicle / Aquaphor) will be required for disease management. Hence risk of systemic absorption 
will be minimal. Participants who experience significant adverse reactions such as allergy to a 
studied agent will be removed from the study. No identifiable features will be included in 
photographs. Participants / guardians can leave questionnaires incomplete if they would rather not 
complete them. Participants / guardians can decline photographs and or skin exams. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
Any clinical findings determined by the Investigator to be important and/or unusual will be referred 
to as an adverse event (AE). Study participants’ parents are asked to contact research staff 
immediately if they experience an adverse reaction at any time during the study. These will be 
documented in a problem events log. The Investigator will use their discretion to remove 
participants from the study, and all problem events will be reported to IRB. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
There are minimal risks in terms of confidentiality. All study participant information will be de-
identified. Any photographs which are obtained will be such that no identifying features (e.g. face) 
are captured. Since this is a pilot study, no confidential or protected information would be taken 
outside of the standard. 
 
e. Financial risks to the participants. 
 


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
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Version 3 Dated:   06/2007 
 
Page 7 of 8 
 
There is very low financial risk to the participants in the rare event that complications occur 
requiring additional medical care for which the financial reimbursement from participation in the 
study is insufficient. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Participants will benefit from free medication and close monitoring of their AD. It would be of great 
interest to AD patients, patients’ families and providers if crisaborole can be shown to reduce the 
amount of TCS used for AD. TCS has multiple adverse effects, and steroid phobia limits 
compliance, resulting in inadequate control of AD. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
$18 for parking costs across 3 study visits. $100 for D0 visit. $100 for D30 visit. $100 for D90 visit. 
$100 bonus for study completion. ($418 total)  
 
Participants will not receive compensation for visits they have not completed. If they do not follow 
instructions appropriately for a visit (such as neglecting to bring medication or diary entries) the 
compensation will be reduced by 50% for the visit. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
We will provide participants with Aquaphor, TCS, and crisaborole / vehicle / control (Aquaphor). 
We will also reimburse participants for their visits. Funding is provided by Pfizer. Pfizer will also 
provide us with crisaborole and vehicle.  
 
--1993. Severity scoring of atopic dermatitis: The SCORAD index. Consensus report of the European task 
force on atopic dermatitis. Dermatology. 1993;186:23–31. 
--Eichenfield L. et al. 2014. Guidelines of care for the management of atopic dermatitis: Section 2. 
Management and treatment of atopic dermatitis with topical therapies. JAAD. Jul;71(1):116-32.  
--Finlay A. and Khan G. 1994. Dermatology Life Quality Index (DLQI)--a simple practical measure for 
routine clinical use. Clin Exp Dermatol. May;19(3):210-6.   
--Grimalt et al. 2006. The steroid-sparing effect of an emollient therapy in infants with atopic dermatitis: A 
randomized controlled study. Dermatology. 214:61-67.  
--Hanifin et al. 2001. The Eczema Area and Severity Index (EASI): Assessment of reliability in atopic 
dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8.  
--Lawson V. et al. 1998. The family impact of atopic dermatitis: The Dermatitis Family Impact 
Questionnaire. Br J Dermatol. 138:107-113.  
--Lewis-Jones M., Finlay A. 1995. The Children’s Dermatology Life Quality Index: Initial validation and 
practical use. Br J Dermatol. 132:942-949.  
--Msika et al. 2008. New emollient with topical corticosteroid-sparing effect in treatment of childhood 
atopic dermatitis: SCORAD and quality of life improvement. Ped Derm. 25(6): 606-612.  
--Paller A. et al. 2016. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 
4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. JAAD. 
Sep;75(3):494-503.e6.  


Date: ____September 18, 2020________________    
Principal Investigator: _Anna Grossberg_____ 
Application Number: _IRB00178631________ 
 
 
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--Phan N.Q. et al. 2012. Assessment of pruritus intensity: Prospective study and validity and reliability of 
the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic 
pruritus. Acta Derm Venereol. 2012;92:502-507.  
--Patel N., Feldman S.R. 2017. Adherence in atopic dermatitis. In: Fortson E., Feldman S., Strowd L. (eds) 
Management of Atopic Dermatitis. Advances in Experimental Medicine and Biology, vol 1027. Springer, 
Cham.  

ICF_001.pdf: 
 
Steroid-reducing Effects of Crisaborole 
    
NCT03832010
9/14/2020


Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: September 14, 2020
Principal Investigator: Anna Grossberg
Application No.: IRB00178631
Page 1 of 11
Combined Parental Permission Informed Consent/Authorization June 2015 Version 3
PARENT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM
Protocol Title: 
Proof of concept investigation of the steroid-reducing effects of 
crisaborole in children
Application No.: 
IRB00178631
Sponsor:
Pfizer, Inc.
Principal Investigator: Anna Grossberg, MD
Rubinstein Bldg Suite 2107
200 N Wolfe St, Baltimore, MD 21287
Tel: 410-955-2049; 410-502-7546 (research program)
Fax: 410-614-9804
1.
What you should know about this study:

You are being asked to allow your child to join a research study. This consent form explains the
research study and your child’s part in the study.  Please read it carefully and take as much time as
you need. Ask your study doctor or the study team to explain any words or information that you do
not understand.

Joining this study is voluntary. If you allow your child to join the study, you can change your mind
later.  There will be no penalty or loss of benefits if you decide not to allow your child to continue
the study.

During the study, we will tell you if we learn any new information that might affect whether you
wish to continue to allow your child to participate.

If we think your child’s participation in this study may affect your child’s clinical care, information
about your child’s study participation will be included in your child’s medical record, which is used
throughout Johns Hopkins.   Doctors outside of Johns Hopkins may not have access to this
information.  You can ask the research team to send this information to any of your child’s doctors.

When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital,
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All
Children’s Hospital.

Biospecimens (urine) will be collected in this study.  Most biospecimens contain DNA, which is the
genetic code for each person.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law.  This Web site will not include information that can identify you. At most, the Web site
will include a summary of the results. You can search this Web site at any time.
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
Patient I.D. Plate
Approved September 14, 2020


Do not use this form for consenting research
participants unless the Johns Hopkins Medicine
Logo appears here.
Date: September 14, 2020
Principal Investigator: Anna Grossberg
Application No.: IRB00178631
Page 2 of 11
Combined Parental Permission Informed Consent/Authorization June 2015 Version 3

If you would like to review the information for this study, or a summary of the results, ask the study 
team doctor for the ClinicalTrials.gov study registration number.

During this study, you will not have access to certain medical information and test results collected 
for study purposes.  If an emergency occurs while your child is in the study, medical information 
needed for your child’s treatment can be made available to your study physician and other 
physicians who treat your child.  When the study is completed, all the information in your child’s 
medical record will be available to you.
2.
Why is this research being done?
This research is being done to find out whether using a non-steroid topical medication called crisaborole, 
reduces topical steroid usage in children with atopic dermatitis (eczema). 
Atopic dermatitis is a chronic skin condition which affects many children. Topical steroids are used to 
treat children with atopic dermatitis. There are side effects associated with topical steroid use including 
but not limited to skin thinning, skin color change, and skin irritation. Fear of steroids and their side 
effects often leads parents to avoid their use. If children with atopic dermatitis are not getting enough 
medication for their skin condition, their condition may flare as a result. 
There is a class of topical medications called calcineurin inhibitors (tacrolimus and pimecrolimus are 
examples of this class) which is also approved for treatment of atopic dermatitis. This class of 
medication is not in the same category as topical steroids and is associated with different side effects. 
Therefore, this class of medication is considered an alternative to steroids and is often used on sensitive 
areas of the body such as the face. However, this class of topical medication has a black box warning 
which lists serious side effects as determined by the Food and Drug Administration (FDA) regarding 
rare cases of malignancy. Concern for this risk can limit the use of these medications. 
Crisaborole is in a different category of medication from topical steroids and topical calcineurin 
inhibitors. It is a topical phosphodiesterase inhibitor. Crisaborole has fewer side effects than topical 
steroids and does not have an associated black box warning. Crisaborole is approved by the FDA for the 
treatment of atopic dermatitis. It is not known whether crisaborole can be an effective steroid-reducing 
medication for children with atopic dermatitis.
Children 2 to 17 years old with mild-moderate atopic dermatitis may join this study.
How many children will be in this study?
Sixty children will be enrolled in this study at Johns Hopkins.
3.
What will happen if you allow your child to join this study?
If you agree to allow your child to be in this study, we will ask you to allow your child to do the 
following things:
Study summary
In this study, your child will be randomized to one of three groups: the crisaborole group, placebo 
(vehicle) group, or control group. 
Randomization is like drawing numbers from a hat. You and your child will not be informed which 
group your child belongs to, this is called “blinding”. Study doctors will also not be informed which 
group your child belongs to, unless if necessary in the management of any problems that arise during the 
study. 
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Depending on your child’s assignment, you will be asked to apply crisaborole, placebo, or control 
product according to study instructions. A placebo is an inactive substance that looks like the study drug 
but contains no active drug. The control product is Aquaphor, which is a skin moisturizer that does not 
contain active drug.
 
The three study groups are: 
1. Crisaborole: crisaborole (blinded) plus topical steroid and Aquaphor
2. Vehicle group: crisaborole vehicle (blinded) plus topical steroid and Aquaphor
3. Control group: Aquaphor (blinded) plus topical steroid and Aquaphor
For each study group, you will be asked to apply moisturizer (Aquaphor) and topical steroid according 
to study instructions as part of standard care. Your child will have their skin examined and 
photographed. You and your child will be asked to complete questionnaires. You will be asked to track 
steroid usage in a diary. You and your child will be asked to return for follow-up visits. You will be 
asked to bring all study product tubes to follow-up visits to have them weighed. This is a 3 month study 
which requires 3 on-site visits. If you feel that this study would take too much time, or you would not be 
able to follow the instructions provided, you should not agree for your child to join the study. 
 
The following sections will describe all the study visits and the procedures to be performed. 
Screening/Consent
First, your child will have a Screening Visit to determine if your child qualifies to participate in this 
study.  

Your child’s medical, surgical and medication history will be reviewed.

Your child’s skin will be examined.

If your child is female and has experienced menstruation, your child will be asked to undergo 
urine pregnancy testing. Results of the pregnancy testing will be provided to you and your child. 
If you or your child do not want this to happen, you/your child should reconsider the decision to 
participate in the study.
Baseline/Day 0
If, based on the results of the screening procedures, your child qualifies to participate in the study, your 
child will be randomized to one of three groups: crisaborole, vehicle, or control. 
At this study visit, the following will be obtained/performed:

A study doctor will examine your child’s skin and determine the severity of their atopic 
dermatitis using a standardized clinical scale.

Responses to questionnaires from you and your child.

Study products (crisaborole, crisaborole vehicle, topical steroid and Aquaphor will be dispensed 
by the research pharmacy according to your child’s group assignment.

Review instructions on how to use the study products. Using Aquaphor, topical steroid, and/or 
crisaborole are part of standard clinical care for atopic dermatitis.

Provide copies of steroid usage diary and review how to complete this during the study.

If your child is currently using a topical calcineurin inhibitor (tacrolimus or pimecrolimus), your 
child will be asked to undergo a 2 week wash out period during which the calcineurin inhibitor is 
discontinued.

Standardized photographs of your child. Although the study team will take measures to de-
identify these photographs (without showing the face or other identifying features), we cannot 
guarantee that your child will not be recognizable. You should know that:
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
You may request that the photographs be stopped at any time.

If you agree to allow the photographs and then change your mind, you may request that the 
imaging be destroyed. If the imaging has had all identifiers removed, we may not be able to 
do this.

These photographs will be used for the purposes of this research and will not be published for 
any other reason.  
Day 30*
*Depending on scheduling convenience for you and your child, this visit may not take place on exactly 
day 30 after starting the study (plus up to 10 days). At this study visit, the following will be 
obtained/performed:

A study doctor will examine your child’s skin and determine the severity of their atopic 
dermatitis using a standardized clinical scale.

Responses to questionnaires from you and your child.

Review instructions on how to use study products.

Obtain completed steroid usage diary entries.

Record weights of study product tubes.

Refills of study products (crisaborole, vehicle, topical steroids and Aquaphor will be dispensed 
as needed by the research pharmacy according to your child’s group assignment.

Standardized photographs of your child.

Record all adverse events experienced by your child.
Day 90**
**Depending on scheduling convenience for you and your child, this visit may not take place on exactly 
day 90 (plus up to 10 days) after starting the study.

This visit will be identical to Day 30 Visit procedures.
Early Withdrawal from the Study 
If you decide to stop your child’s participation in the study early, you should inform the study staff as 
soon as possible.
Subject Responsibilities 
You and your child will have the following responsibilities during this study: 

Provide complete information about your child’s medical history and current medical conditions. 

Talk to your study doctor before changing any of your child’s medications. 

Your child cannot have been in another study with another investigational study drug within the 
last 30 days. Your child also cannot participate in another study while your child is enrolled in 
this study and during the following month after the end of this study. 

Come to study visits as scheduled. 

Follow study instructions for how to use the study products.

Bring completed diary entries and medication tubes to follow-up visits.

Promptly report any side effects or health problems your child is experiencing even if you don’t 
think they are important or related to the study products or procedures. 

During the study, your child must not use any topical calcineurin inhibitor class medications 
(tacrolimus, pimecrolimus). 

Do not share the study products with anyone else. 

Tell the study staff if you wish for your child to stop taking part in the study. 
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
If you suspect that your child is pregnant, contact the study staff immediately. 
How long will your child be in the study?
Your child will be in this study for 90 days.
4.
What are the risks or discomforts of the study?
The risk of your child joining this study is that their atopic dermatitis may not be as well-controlled as 
compared with your child being under standard clinical care. If your child experiences any problems 
with their skin or adverse reactions to any study products or study procedures, you are advised to contact 
a study doctor about the issue as soon as possible.
Risks associated with study products:
Crisaborole: This can be associated with unlikely reactions of application site pain (4 out of 100 or 4%), 
allergic reactions and hives (less than 1 out of 100 or less than 1%). 
Topical steroids: Topical steroids including hydrocortisone and triamcinolone which are used in this 
study may be associated with unlikely reactions of localized burning, itching, skin irritation, acne, 
allergic reaction, stretchmarks, hair follicle inflammation, excessive hair growth, skin color change, skin 
thinning, rash, skin infection, dry skin. Rare but serious side effects include hormonal abnormalities and 
abnormalities of laboratory results including changes in salt and sugar levels.
Vehicle: If your child is randomly assigned to the vehicle group, a placebo product will be used in place 
of crisaborole. There is an unlikely risk that your child will experience an allergic reaction to the 
ingredients in the vehicle product. There is a risk that your child’s atopic dermatitis will get worse while 
using the vehicle product, which does not contain active medication to treat your child’s atopic 
dermatitis.
Aquaphor: If your child is randomly assigned to the control group, Aquaphor will be used in place of 
crisaborole. There is an unlikely risk that your child will experience an allergic reaction to the 
ingredients in Aquaphor.  There is a risk that your child’s atopic dermatitis will get worse while using 
Aquaphor, which does not contain active medication to treat your child’s atopic dermatitis.
Risks associated with the study procedures: 
Urine pregnancy testing: If your child has experienced menstruation, your child will be asked to undergo 
urine pregnancy testing. No pain is expected to occur as a result of this study procedure. Your child may 
find the procedure stressful. You may find this study procedure inconvenient. There is a risk of you and 
your child discovering that your child is pregnant. 
Photographs and physical exams: No pain is expected to occur as a result of these study procedures. All 
photographs taken during the study will only be identified by the study number, your child’s study 
identification number, the visit number and/or date, and the photographed area. To protect your child’s 
identity, photographs of the face will not be taken.
Wash-out period from topical calcineurin inhibitors: If your child is using a topical calcineurin inhibitor 
(tacrolimus, pimecrolimus) for their atopic dermatitis, your child will be asked to stop using the 
medication(s) for 2 weeks prior to beginning study protocols. Your child will be asked to not use the 
medication(s) for the entire duration of the study. There is a risk that your child’s atopic dermatitis will 
flare after discontinuing the medication(s).
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Confidentiality: There is an unlikely risk that information about your child may become known to 
people outside this study.  Although every effort will be made to protect your child’s confidentiality, 
there is still the possibility that information about your child may become known outside of this study. 
 
Questionnaires: You and your child may get tired or bored when we are asking your or your child 
questions or to complete questionnaires. You/your child do not have to answer any question that you or 
your child do not want to answer. 
 
There may be side effects and discomforts that are not yet known.
5.
Are there risks related to pregnancy?
Any female child who has experienced menstruation is required to undergo urine pregnancy testing prior 
to beginning study participation. If your child becomes pregnant at any time during the study, they will 
be removed from the study. Results of pregnancy testing will be provided to you and your child. If you 
or your child do not wish to be tested for pregnancy, you or your child should decline to participate in 
this study.  This research may hurt an embryo or fetus in ways we do not currently know.
6.
Are there benefits to your child from being in the study?
There may or may not be a direct benefit to your child from being in this study. It is possible that your 
child’s atopic dermatitis will get better, stay the same, or get worse. If your child takes part in this study, 
your child may help others in the future.
7.
What are your options if you do not want your child to be in the study?
You do not have to allow your child to join this study.  
If your child does not take part in the study, your child’s care at Johns Hopkins will not be affected.
8.
Will it cost you anything to allow your child to be in this study?
No. You will receive a separate Insurance and Research Participant Financial Responsibility Information 
Sheet (Sheet). 
This Sheet will give you the following information:

The procedures, tests, drugs or devices that are part of this research and that will be paid for by 
the study (no cost to you).  

The procedures, tests, drugs or devices that will be billed to you and/or your health insurer.  If 
you have health insurance, you will be responsible for any co-pays or deductibles not covered by 
your insurance. 
9.
Will you or your child be paid if you allow your child to join this study?
You will be paid $100 after your child has completed the Day 0 visit, $100 after completing the Day 30 
visit, and $100 after completing the Day 90 visit. There is a $100 bonus if your child completes the 
study. You will be compensated for parking costs. You will not receive compensation for visits your 
child has not completed. If you do not follow instructions appropriately for a visit (such as forgetting to 
bring the study drug or diary entries) the compensation will be reduced by 50% for the visit.
You may be required to provide your social security number to be paid for taking part in this study. 
Federal tax law requires that you report your research payments when you file your taxes. If your total 
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payments from Johns Hopkins exceed $600 per year, Johns Hopkins will report these payments to the 
Internal Revenue Service and you will receive a 1099-MISC form from us.
10.
Can your child leave the study early?

You can agree to allow your child to be in the study now and change your mind later.

If you wish to end your child’s participation, please tell us right away.

Leaving this study early will not stop your child from getting regular medical care. 

If your child leaves the study early, Johns Hopkins may use or give out your child’s health 
information that it already has, if the information is needed for this study or any follow-up activities.
11.
Why might we take your child out of the study early?
Your child may be taken out of the study if:

Staying in the study would be harmful to your child’s health.

Your child needs treatment not allowed in the study.

You or your child fails to follow instructions.

Your child becomes pregnant.

The study is cancelled.

There may be other reasons to take your child out of the study that we do not know at this time.

If your child is taken out of the study early, Johns Hopkins may use or give out your child’s health 
information that it already has if the information is needed for this study or any follow-up activities.
12.
How will your child’s privacy be protected?
We have rules to protect information about your child.  Federal and state laws and the federal medical 
Privacy Rule also protect your child’s privacy.  By signing this form you provide your permission, 
called your “authorization,” for the use and disclosure of information protected by the Privacy Rule.
The research team working on the study will collect information about your child.  This includes things 
learned from the procedures described in this consent form.  They may also collect other information 
including your child’s name, address, date of birth, and information from your child’s medical records 
(which may include information about HIV status, drug, alcohol or STD treatment, genetic test results, 
or mental health treatment).
The research team will know your child’s identity and that your child is in the research study.  Other 
people at Johns Hopkins, particularly your doctors, may also see or give out your child’s information. 
We make this information available to your child’s doctors for your child’s safety.   
People outside of Johns Hopkins may need to see or receive your child’s information for this study.  
Examples include government agencies (such as the Food and Drug Administration), safety monitors, 
other sites in the study and companies that sponsor the study. 
If your child is in a cancer study that receives federal funding, the National Cancer Institute (NCI) now 
requires that we report identifiable information (such as, zip code) about your child’s participation.  You 
may contact the NCI if you have questions about how this information is used. 
We cannot do this study without your authorization to use and give out your child’s information.  You 
do not have to give us this authorization.  If you do not, then you may not join this study.
We will use and disclose your child’s information only as described in this form and in our Notice of 
Privacy Practices; however, people outside Johns Hopkins who receive your child’s information may not 
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be covered by this promise or by the federal Privacy Rule.  We try to make sure that everyone who 
needs to see your child’s information keeps it confidential – but we cannot guarantee that your 
information will not be re-disclosed.
The use and disclosure of your child’s information has no time limit. You may revoke (cancel) your 
permission to use and disclose your child’s information at any time by notifying the Principal 
Investigator of this study by phone or in writing.  If you contact the Principal Investigator by phone, you 
must follow-up with a written request that includes the study number and your contact information.  The 
Principal Investigator’s name, address, phone and fax information are on page one of this consent form. 
If you do cancel your authorization to use and disclose your child’s information, your child’s part in this 
study will end and no further information about your child will be collected. Your revocation 
(cancellation) would not affect information already collected in the study, or information we disclosed 
before you wrote to the Principal Investigator to cancel your authorization.
13.
Will the study require any of your other health care providers to share your child’s 
health information with the researchers of this study? 
As a part of this study, the researchers may ask to see your child’s health care records from her/his other 
health care providers.
14.
What treatment costs will be paid if your child is injured in this study? 
Johns Hopkins does not have a program to pay you if your child is hurt or has other bad results from 
being in the study.  However, medical care at Johns Hopkins is open to your child as it is to all sick or 
injured people. 
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not 
covered by a health insurer will be billed to you.
By signing this form you and your child will not give up any rights you have to seek compensation for 
injury.
15.
What other things should you know about this research study?
a. What is the Institutional Review Board (IRB) and how does it protect you? 
The Johns Hopkins Medicine IRB is made up of:

Doctors

Nurses

Ethicists

Non-scientists

and people from the local community. 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your child’s rights as a 
participant or if you think you or your child have not been treated fairly.  The IRB office number is 
410-955-3008. You may also call this number for other questions, concerns or complaints about the 
research. 
When the Johns Hopkins School of Medicine Institutional Review Board (IRB) reviews a study at 
another site, that site (institution) is solely responsible for the safe conduct of the study and for 
following the protocol approved by the Johns Hopkins IRB.
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b. What do you do if you have questions about the study?   
Call the principal investigator, Dr. Anna Grossberg at 410-955-2049. If you wish, you may contact 
the principal investigator by letter or by fax. The address and fax number are on page one of this 
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the 
IRB office at 410-955-3008.  
c.
What should you do if your child injured or ill as a result of being in this study? 
If you think your child is injured or ill because of this study, call Dr. Anna Grossberg at 410-955-
2049 or our cutaneous translational research program (CTReP) at 410-502-7546 during regular 
office hours.
If your child has an urgent medical problem related to taking part in this study, call Dr. Anna 
Grossberg at 410-955-2049 or CTReP at 410-502-7546 during regular office hours, and 410-955-
5000 after hours and on weekends, ask to speak to the Dermatology resident on-call.
d. What happens to Data and Biospecimens that are collected in the study? 
Johns Hopkins and our research partners work to understand and cure diseases.  The biospecimens 
and/or data your child provides are important to this effort.
If you allow your child to join this study, you should understand that you/your child will not own 
your child’s biospecimens or data, and should researchers use them to create a new product or idea, 
you/your child will not benefit financially.  
With appropriate protections for privacy, Johns Hopkins may share your child’s biospecimens and 
information with our research sponsors and partners.   
16.
Assent Statement
This research study has been explained to my child in my presence in language my child can understand. 
He/she has been encouraged to ask questions about the study now and at any time in the future.
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Combined Parental Permission Informed Consent/Authorization June 2015 Version 3
17.
What does your signature on this consent form mean?
Your signature on this form means that:

you understand the information given to you in this form 

you accept the provisions in the form

you agree to allow your child to join the study 
You and your child will not give up any legal rights by signing this consent form. 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM
__________________________________________________________________________________________
Signature of Parent                                                                                     (Print Name)                                       
Date/Time
__________________________________________________________________________________________
Signature of Person Obtaining Consent                                                     (Print Name)                                 
Date/Time
___________________________________________________________________________________________________
Signature of Legally Authorized Representative (LAR)                            (Print Name)                                       
Date/Time
For CHILD PARTICIPANT
__________________________________________________________________________________________________
Description of  LAR’s authority under Maryland Law to act as surrogate health care 
Date/Time
decision-maker for child research participant (for example, Legal Guardian; Court-ordered representative)
__________________________________________________________________________________________
Signature of Child Participant (optional unless IRB required)                  (Print Name)                               
Date/Time
I have received the separate Insurance and Research Participant Financial Responsibility Information Sheet.  
____________________________________________________________________________________________________
Signature of Participant, LAR or Parent/Guardian                                    (Print Name)                    
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; 
A COPY MUST BE GIVEN TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE 
FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S 
MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED). 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN 
THE CONSENT OF RESEARCH PARTICIPANTS.  
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Combined Parental Permission Informed Consent/Authorization June 2015 Version 3
DOCUMENTATION OF PHYSICIAN/MID-LEVEL PROVIDER CONSENT
My signature below indicates that I have discussed the risks, benefits, and alternatives, answered any 
questions, and believe the participant is able to make an informed choice to join the study.
__________________________________________________________________________________________________
Signature of Physician/Mid-Level Provider                     (Print Name)                                                                    Date/Time  
______________________________________________________________________________________________________________
Signature of Parent                                                           (Print Name)                                                                    Date/Time      
____________________________________________________________________________________________________________
Signature of Legally Authorized Representative (LAR)                        (Print Name)
Date/Time 
For CHILD PARTICIPANT
____________________________________________________________________________________________________________
Description of LAR’s authority under state or applicable local law to act as surrogate health care                                 Date/Time                          
decision-maker for child research participant (for example, Legal Guardian, court-ordered representative)
__________________________________________________________________________________________________
Signature of Child Participant (optional unless IRB required)              (Print Name)                                       
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; 
A COPY MUST BE GIVEN TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE 
FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S 
MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED). 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN 
THE CONSENT OF RESEARCH PARTICIPANTS.
Approved September 14, 2020