Atopic DermatitisPhase 4NCT03832010

Steroid-reducing Effects of Crisaborole

A Phase 4 study testing Crisaborole, Hydrocortisone Ointment and Triamcinolone ointment in people with Atopic Dermatitis and Eczema, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Atopic Dermatitis, Eczema
What is being tested?: Crisaborole, Hydrocortisone Ointment and Triamcinolone ointment
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2019to 16 Feb 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children aged 2 or older (<18).
Diagnosed with atopic dermatitis.
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).

Who cannot join

Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment]).
At baseline, AD is severe (score of 4 [severe] on the IGA scale).
Medical problems which interfere with completion of protocols in this study.
Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.)
Participant is enrolled in another research study.
Participant or participant's guardian(s) are unable to follow instructions as required in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children

Read the 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.

Conditions: Atopic Dermatitis, Eczema
Being tested: Crisaborole, Hydrocortisone Ointment, Triamcinolone ointment, Aquaphor
Keywords: Topical steroid, Crisaborole, Topical calcineurin inhibitor
Medical subject headings: Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CrisaboroleDrug
Also called Eucrisa
Participants will be instructed to apply crisaborole to affected areas with eczema.
Hydrocortisone OintmentDrug
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
Triamcinolone ointmentDrug
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
AquaphorDrug
Participants will be instructed to moisturize all over the body with Aquaphor.

Study groups in NCT03832010
Study group	Role	What they receive
Crisaborole	Active comparator	Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema. Receives: Drug: Crisaborole; Drug: Hydrocortisone Ointment; Drug: Triamcinolone ointment; Drug: Aquaphor
Vehicle	Placebo comparator	Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema. Receives: Drug: Hydrocortisone Ointment; Drug: Triamcinolone ointment; Drug: Aquaphor
Control	Sham comparator	Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema. Receives: Drug: Hydrocortisone Ointment; Drug: Triamcinolone ointment; Drug: Aquaphor

What is being measured

The primary outcome is the main question the study is designed to answer.

Steroid Usage Quantity
Steroid usage measured in medication weight (grams)
Measured: Day 30
Steroid Usage Quantity
Steroid usage measured in medication weight (grams)
Measured: Day 90
Steroid Usage Frequency
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Measured: Day 30
Steroid Usage Frequency
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Measured: Day 90

Secondary outcomes (12)

Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score
Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Highest score corresponds with highest severity of eczema. Lowest score corresponds with lowest severity of eczema.
Measured: Day 0
Eczema Severity Assessed by SCORAD Score
Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
Measured: Day 30
Eczema Severity Assessed by SCORAD Score
Clinical assessment using SCORAD score: minimum score = 0, maximum score = 103. Higher score corresponds with increased severity of eczema. Lowest score corresponds with lowest severity of eczema.
Measured: Day 90
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 0
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 30
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Children's Dermatology Life Quality Index (ages 15 or younger). The minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 90
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 0
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 30
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Dermatitis Family Impact Questionnaire. Minimum score is 0, maximum score is 30. The highest score corresponds with most severe impairment of quality of life. The lowest score corresponds with lowest impairment of quality of life.
Measured: Day 90
Severity of Itching as Assessed by Pruritus Score
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Measured: Day 0
Severity of Itching as Assessed by Pruritus Score
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Measured: Day 30
Severity of Itching as Assessed by Pruritus Score
Pruritus score determined using Numerical Rating Scale. Minimum score is 0. Maximum score is 10. Lowest score means no itching. Highest score corresponds to the most severe itching imaginable by patient.
Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 201916 Feb 2024

First posted6 Feb 2019
Study start17 Dec 2019
Primary completion16 Feb 2024
Study completion16 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03832010
Sponsor's protocol ID: IRB00178631
Status last verified: Jul 2024
First submitted: 25 Jan 2019
Last updated: 19 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. 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. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.
PubMed 27417017
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PubMed 24813302

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
ClinicalTrials.gov ID: NCT03832010
Acronym / sponsor ID: IRB00178631
Conditions: Atopic Dermatitis, Eczema
Keywords: Topical steroid, Crisaborole, Topical calcineurin inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Pfizer
Study start: 17 Dec 2019 (actual)
Primary completion: 16 Feb 2024 (actual)
Study completion: 16 Feb 2024 (actual)
First posted: 6 Feb 2019 (actual)
Results: Posted 19 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Crisaborole	Active comparator	Drug: Crisaborole, Drug: Hydrocortisone Ointment, Drug: Triamcinolone ointment, Drug: AquaphorParticipants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Vehicle	Placebo comparator	Drug: Hydrocortisone Ointment, Drug: Triamcinolone ointment, Drug: AquaphorParticipants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Control	Sham comparator	Drug: Hydrocortisone Ointment, Drug: Triamcinolone ointment, Drug: AquaphorParticipants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Children aged 2 or older (<18).
Diagnosed with atopic dermatitis.
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).

Key exclusion criteria (6 listed)

Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment]).
At baseline, AD is severe (score of 4 [severe] on the IGA scale).
Medical problems which interfere with completion of protocols in this study.
Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.)
Participant is enrolled in another research study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CrisaboroleAlso: EucrisaParticipants will be instructed to apply crisaborole to affected areas with eczema.	Drug	Crisaborole
Hydrocortisone OintmentParticipants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.	Drug	Control, Crisaborole, Vehicle
Triamcinolone ointmentParticipants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.	Drug	Control, Crisaborole, Vehicle
AquaphorParticipants will be instructed to moisturize all over the body with Aquaphor.	Drug	Control, Crisaborole, Vehicle

Primary outcome

Steroid Usage Quantity
Time frame: Day 30
Steroid usage measured in medication weight (grams)
Steroid Usage Quantity
Time frame: Day 90
Steroid usage measured in medication weight (grams)
Steroid Usage Frequency
Time frame: Day 30
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.
Steroid Usage Frequency
Time frame: Day 90
Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

12 secondary outcomes

Eczema Severity as Assessed by SCORing Atopic Dermatitis (SCORAD) Score
Time frame: Day 0
Eczema Severity Assessed by SCORAD Score
Time frame: Day 30
Eczema Severity Assessed by SCORAD Score
Time frame: Day 90
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Time frame: Day 0
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Time frame: Day 30
Quality of Life for Participant as Assessed by Children's Dermatology Life Quality Index
Time frame: Day 90
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Time frame: Day 0
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Time frame: Day 30
Quality of Life for Family as Assessed by Dermatitis Family Impact Questionnaire
Time frame: Day 90
Severity of Itching as Assessed by Pruritus Score
Time frame: Day 0
Severity of Itching as Assessed by Pruritus Score
Time frame: Day 30
Severity of Itching as Assessed by Pruritus Score
Time frame: Day 90

Results and safety

Results posted to the registry on 19 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crisaborole	8	4
Vehicle	7	5
Control	9	8

Primary outcome: Steroid Usage Quantity

Time frame: Day 30. Mean (Standard Deviation). Unit: grams

Measure	Crisaborole n = 4	Vehicle n = 5	Control n = 5
Value	7.27 (10.00)	10.78 (20.77)	8.22 (10.39)

Population analysed: 3 withdrew, 7 lost to followup

Primary outcome: Steroid Usage Quantity

Time frame: Day 90. Mean (Standard Deviation). Unit: grams

Measure	Crisaborole n = 2	Vehicle n = 4	Control n = 6
Value	37.82 (27.49)	16.15 (18.79)	5.43 (11.13)

Population analysed: 3 withdrew, 9 lost to followup

Primary outcome: Steroid Usage Frequency

Time frame: Day 30. Mean (Standard Deviation). Unit: steroids used per week

Measure	Crisaborole n = 5	Vehicle n = 5	Control n = 8
Value	1.81 (1.41)	1.27 (1.21)	1.85 (1.09)

Primary outcome: Steroid Usage Frequency

Time frame: Day 90. Mean (Standard Deviation). Unit: steroids used per week

Measure	Crisaborole n = 3	Vehicle n = 5	Control n = 8
Value	2.74 (3.62)	1.71 (1.80)	1.38 (1.11)

Population analysed: Participants lost to follow-up in recording diaries, data not collected.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 104 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Crisaborole	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Vehicle	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Control	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27417017Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. 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. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.
Background: PubMed 24813302Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Grossberg, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Crisaborole, Hydrocortisone Ointment and Triamcinolone ointment in people with Atopic Dermatitis and Eczema, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steroid Usage Quantity (time frame: Day 30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03832010, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.