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Steroid-reducing Effects of Crisaborole

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ClinicalTrials.gov Identifier: NCT03832010
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Crisaborole Drug: Hydrocortisone Ointment Drug: Triamcinolone ointment Drug: Aquaphor Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Active Comparator: Crisaborole
Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Drug: Crisaborole
Participants will be instructed to apply crisaborole to affected areas with eczema.
Other Name: Eucrisa

Drug: Hydrocortisone Ointment
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.

Drug: Triamcinolone ointment
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.

Drug: Aquaphor
Participants will be instructed to moisturize all over the body with Aquaphor.

Placebo Comparator: Vehicle
Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Drug: Hydrocortisone Ointment
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.

Drug: Triamcinolone ointment
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.

Drug: Aquaphor
Participants will be instructed to moisturize all over the body with Aquaphor.

Sham Comparator: Control
Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Drug: Hydrocortisone Ointment
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.

Drug: Triamcinolone ointment
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.

Drug: Aquaphor
Participants will be instructed to moisturize all over the body with Aquaphor.




Primary Outcome Measures :
  1. Steroid usage quantity [ Time Frame: Day 30 ]
    Steroid usage measured in medication weight (grams)

  2. Steroid usage quantity [ Time Frame: Day 90 ]
    Steroid usage measured in medication weight (grams)

  3. Steroid usage frequency [ Time Frame: Day 30 ]
    Steroid usage measured in diary entries

  4. Steroid usage frequency [ Time Frame: Day 90 ]
    Steroid usage measured in diary entries

  5. Steroid refills [ Time Frame: Day 30 ]
    Steroid usage measured in number of refills

  6. Steroid refills [ Time Frame: Day 90 ]
    Steroid usage measured in number of refills


Secondary Outcome Measures :
  1. Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score [ Time Frame: Day 0 ]
    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.

  2. Eczema severity assessed by SCORAD score [ Time Frame: Day 30 ]
    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.

  3. Eczema severity assessed by SCORAD score [ Time Frame: Day 90 ]
    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.

  4. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [ Time Frame: Day 0 ]
    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.

  5. Quality of life for participant as assessed by Dermatology Life Quality Index [ Time Frame: Day 0 ]
    Dermatology Life Quality Index (ages 16 or older). 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.

  6. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [ Time Frame: Day 30 ]
    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.

  7. Quality of life for participant as assessed by Dermatology Life Quality Index [ Time Frame: Day 30 ]
    Dermatology Life Quality Index (ages 16 or older). 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.

  8. Quality of life for participant as assessed by Children's Dermatology Life Quality Index [ Time Frame: Day 90 ]
    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.

  9. Quality of life for participant as assessed by Dermatology Life Quality Index [ Time Frame: Day 90 ]
    Dermatology Life Quality Index (ages 16 or older). 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.

  10. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [ Time Frame: Day 0 ]
    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.

  11. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [ Time Frame: Day 30 ]
    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.

  12. Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [ Time Frame: Day 90 ]
    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.

  13. Severity of itching as assessed by Pruritus score [ Time Frame: Day 0 ]
    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.

  14. Severity of itching as assessed by Pruritus score [ Time Frame: Day 30 ]
    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.

  15. Severity of itching as assessed by Pruritus score [ Time Frame: Day 90 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832010


Contacts
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Contact: Ji Qi, MD 443-287-8948 jqi3@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Bernard Cohen, MD    443-287-8948    bcohena@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Pfizer
Investigators
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Principal Investigator: Bernard Cohen, MD Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03832010     History of Changes
Other Study ID Numbers: IRB00178631
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johns Hopkins University:
Topical steroid
Crisaborole
Topical calcineurin inhibitor

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Petrolatum
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents