Steroid-reducing Effects of Crisaborole
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Skin and Soft Tissue Infections, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 4/4/2019 |
| Start Date: | April 2019 |
| End Date: | June 2020 |
| Contact: | Ji Qi, MD |
| Email: | jqi3@jhmi.edu |
| Phone: | 443-287-8948 |
Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
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.
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.
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.
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.
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.
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