Steroid-reducing Effects of Crisaborole
Primary Purpose
Atopic Dermatitis, Eczema
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Crisaborole
Hydrocortisone Ointment
Triamcinolone ointment
Aquaphor
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Topical steroid, Crisaborole, Topical calcineurin inhibitor
Eligibility 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.
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Sham Comparator
Arm Label
Crisaborole
Vehicle
Control
Arm Description
Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Outcomes
Primary Outcome Measures
Steroid usage quantity
Steroid usage measured in medication weight (grams)
Steroid usage quantity
Steroid usage measured in medication weight (grams)
Steroid usage frequency
Steroid usage measured in diary entries
Steroid usage frequency
Steroid usage measured in diary entries
Steroid refills
Steroid usage measured in number of refills
Steroid refills
Steroid usage measured in number of refills
Secondary Outcome Measures
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.
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.
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.
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.
Quality of life for participant as assessed by Dermatology Life Quality Index
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.
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.
Quality of life for participant as assessed by Dermatology Life Quality Index
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.
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.
Quality of life for participant as assessed by Dermatology Life Quality Index
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03832010
First Posted
January 25, 2019
Last Updated
June 8, 2023
Sponsor
Johns Hopkins University
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03832010
Brief Title
Steroid-reducing Effects of Crisaborole
Official Title
Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Pfizer
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Topical steroid, Crisaborole, Topical calcineurin inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crisaborole
Arm Type
Active Comparator
Arm Description
Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
Intervention Type
Drug
Intervention Name(s)
Crisaborole
Other Intervention Name(s)
Eucrisa
Intervention Description
Participants will be instructed to apply crisaborole to affected areas with eczema.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone Ointment
Intervention Description
Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone ointment
Intervention Description
Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
Intervention Type
Drug
Intervention Name(s)
Aquaphor
Intervention Description
Participants will be instructed to moisturize all over the body with Aquaphor.
Primary Outcome Measure Information:
Title
Steroid usage quantity
Description
Steroid usage measured in medication weight (grams)
Time Frame
Day 30
Title
Steroid usage quantity
Description
Steroid usage measured in medication weight (grams)
Time Frame
Day 90
Title
Steroid usage frequency
Description
Steroid usage measured in diary entries
Time Frame
Day 30
Title
Steroid usage frequency
Description
Steroid usage measured in diary entries
Time Frame
Day 90
Title
Steroid refills
Description
Steroid usage measured in number of refills
Time Frame
Day 30
Title
Steroid refills
Description
Steroid usage measured in number of refills
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score
Description
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.
Time Frame
Day 0
Title
Eczema severity assessed by SCORAD score
Description
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.
Time Frame
Day 30
Title
Eczema severity assessed by SCORAD score
Description
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.
Time Frame
Day 90
Title
Quality of life for participant as assessed by Children's Dermatology Life Quality Index
Description
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.
Time Frame
Day 0
Title
Quality of life for participant as assessed by Dermatology Life Quality Index
Description
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.
Time Frame
Day 0
Title
Quality of life for participant as assessed by Children's Dermatology Life Quality Index
Description
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.
Time Frame
Day 30
Title
Quality of life for participant as assessed by Dermatology Life Quality Index
Description
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.
Time Frame
Day 30
Title
Quality of life for participant as assessed by Children's Dermatology Life Quality Index
Description
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.
Time Frame
Day 90
Title
Quality of life for participant as assessed by Dermatology Life Quality Index
Description
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.
Time Frame
Day 90
Title
Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
Description
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.
Time Frame
Day 0
Title
Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
Description
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.
Time Frame
Day 30
Title
Quality of life for family as assessed by Dermatitis Family Impact Questionnaire
Description
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.
Time Frame
Day 90
Title
Severity of itching as assessed by Pruritus score
Description
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.
Time Frame
Day 0
Title
Severity of itching as assessed by Pruritus score
Description
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.
Time Frame
Day 30
Title
Severity of itching as assessed by Pruritus score
Description
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.
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Grossberg, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27417017
Citation
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. Erratum In: J Am Acad Dermatol. 2017 Apr;76(4):777.
Results Reference
background
PubMed Identifier
24813302
Citation
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.
Results Reference
background
Learn more about this trial
Steroid-reducing Effects of Crisaborole
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