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NCT Number: NCT03832010

Steroid-reducing Effects of Crisaborole

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crisaborole

Drug

Participants will be instructed to apply crisaborole to affected areas with eczema.

Other names: Eucrisa

Hydrocortisone Ointment

Drug

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

Triamcinolone ointment

Drug

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

Aquaphor

Drug

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

Primary outcomes

  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. Weekly average frequency of steroid use is reported.

  4. Steroid Usage Frequency

    Time frame: Day 90

    Steroid usage measured in diary entries. Weekly average frequency of steroid use is reported.

Secondary outcomes

  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 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2019
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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