Steroid-reducing Effects of Crisaborole
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
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.
|
Outcome Measures
Primary Outcome Measures
- Steroid usage quantity [Day 30]
Steroid usage measured in medication weight (grams)
- Steroid usage quantity [Day 90]
Steroid usage measured in medication weight (grams)
- Steroid usage frequency [Day 30]
Steroid usage measured in diary entries
- Steroid usage frequency [Day 90]
Steroid usage measured in diary entries
- Steroid refills [Day 30]
Steroid usage measured in number of refills
- Steroid refills [Day 90]
Steroid usage measured in number of refills
Secondary Outcome Measures
- Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score [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.
- Eczema severity assessed by SCORAD score [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.
- Eczema severity assessed by SCORAD score [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.
- Quality of life for participant as assessed by Children's Dermatology Life Quality Index [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.
- Quality of life for participant as assessed by Dermatology Life Quality Index [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.
- Quality of life for participant as assessed by Children's Dermatology Life Quality Index [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.
- Quality of life for participant as assessed by Dermatology Life Quality Index [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.
- Quality of life for participant as assessed by Children's Dermatology Life Quality Index [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.
- Quality of life for participant as assessed by Dermatology Life Quality Index [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.
- Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [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.
- Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [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.
- Quality of life for family as assessed by Dermatitis Family Impact Questionnaire [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.
- Severity of itching as assessed by Pruritus score [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.
- Severity of itching as assessed by Pruritus score [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.
- Severity of itching as assessed by Pruritus score [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- Pfizer
Investigators
- Principal Investigator: Anna Grossberg, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- IRB00178631