Crisaborole

Crisaborole 2% ointment (Eucrisa in the US, Staquis in the EU) is a steroid-free topical treatment for mild-to-moderate Atopic Dermatitis. It inhibits phosphodiesterase-4 (PDE4), an enzyme inside immune cells. Blocking PDE4 is expected to reduce the release of inflammatory cytokines, including IL-4 and IL-5 from the Th2 Immune Response (EMA Staquis overview) (unverified). Like Topical Calcineurin Inhibitors and Ruxolitinib Cream, it is a steroid-sparing alternative to Topical Corticosteroids and does not cause Skin Atrophy. It is applied twice daily.

Crisaborole [treats] Atopic Dermatitis Crisaborole [opposes] Th2 Immune Response Crisaborole [relates] Topical Calcineurin Inhibitors Crisaborole [relates] Topical Corticosteroids

Licensing: US from 3 months; gone from the EU. The FDA first approved Eucrisa on 14 December 2016. An efficacy supplement approved on 23 March 2020 extended it to infants (Drugs@FDA NDA 207695). The current US label covers mild-to-moderate AD “in adult and pediatric patients 3 months of age and older” (FDA label, 2025). In the EU, Staquis was authorised on 27 March 2020 for adults and children from 2 years. It was never marketed, and the licence was withdrawn on 31 January 2022 at Pfizer’s request “for commercial reasons” (EMA). Pfizer had already dropped the remaining EU paediatric investigation plan studies for business reasons (EMA variation report) (unverified). No UK (MHRA) licence was checked this round, so its UK status is unverified. In practice, UK and European parents are unlikely to be offered it.

Conflict: [FDA Eucrisa label, 2025] says crisaborole is licensed for mild-to-moderate AD from 3 months. [EMA Staquis EPAR, 2022] says the EU authorisation (from 2 years) was withdrawn in January 2022 and the product was never marketed. This is a regulatory/commercial split, not a safety disagreement. Unresolved for UK — add to open_questions.

FDA [regulates] Crisaborole European Medicines Agency [regulates] Crisaborole

Evidence in infants: CrisADe CARE 1. CrisADe CARE 1 (Schlessinger et al., Am J Clin Dermatol 2020) treated 137 infants aged 3 to under 24 months (mean 13.6 months) with mild-to-moderate AD. They used crisaborole twice daily for 28 days. By day 29, 30.2% had clear or almost-clear skin with at least a 2-grade improvement. Mean EASI fell 57.5% and POEM fell 8.5 points. Blood levels in infants were similar to those in children over 2. The study was open-label with no vehicle (placebo) arm and lasted only 4 weeks, so it shows tolerability and exposure rather than proven efficacy in infants. The efficacy evidence comes from vehicle-controlled trials in patients aged 2 and over (1,313 paediatric subjects in two 28-day trials; FDA label). An industry analyst source also reports that key opinion leaders see the PDE4 class as having “limited class efficacy” in AD (GlobalData 2022, search snippet only, not fetched) (unverified). That is why evidence_level is “moderate”.

Crisaborole [relates] EASI Crisaborole [relates] POEM

Side effects. The main side effect is application-site pain, described as burning or stinging. It affected 4% on crisaborole against 1% on vehicle in the pivotal trials (FDA label). In the infant study, treatment-related events affected 16.1%, mostly application-site pain (3.6%), discomfort (2.9%) and redness (2.9%) (CrisADe CARE 1). Contact urticaria and hypersensitivity reactions are rare (<1%) but labelled; the product should be stopped if they occur. The EU product information notes 90 mg propylene glycol per gram of ointment (unverified). For a toddler who already fights cream application, stinging on raw skin can be a practical barrier, similar to the burning seen with Topical Calcineurin Inhibitors.

Stinging on broken skin

Crisaborole can burn or sting, especially on raw, open or freshly scratched skin. Stop and seek advice if hives, swelling or spreading redness appear (possible contact urticaria/hypersensitivity).

Crisaborole [relates] Allergic Contact Dermatitis Crisaborole [relates] Itch-Scratch Cycle

What parents report (evidence: anecdotal). Parents report mixed results. One father says Eucrisa “couldn’t have worked any better” for persistent mild eczema, with no burning (r/ScienceBasedParenting). Another parent says it stung so badly on a toddler’s raw skin that two adults were needed for each application, on top of a US$700 tube and a US$180 visit. An adult user warned that in non-verbal children “If they seem to be in real, terrible pain, they might actually be” (r/eczema). One severely affected 2.5-year-old reacted after a single use. See Parent Experiences.

Crisaborole [relates] Parent Experiences

Licensing update (Oct 2026). Nothing has changed. The EMA register still lists Staquis as withdrawn. The AAD Pediatric Guideline 2026 makes a strong recommendation for crisaborole from 3 months in mild-to-moderate AD, on moderate-certainty evidence. It is still the only non-steroid cream or ointment with a US licence below age 2. Two newer once-daily PDE4 and AhR creams are now US-licensed from age 2: Roflumilast Cream (0.05%, October 2025) and Tapinarof Cream (December 2024). The AAD says roflumilast may sting less than crisaborole.

AAD Pediatric Guideline 2026 [supports] Crisaborole Roflumilast Cream [relates] Crisaborole

Connections

• Atopic Dermatitis — treats mild-moderate AD, US ≥3 months, source: FDA Eucrisa label 2025
• Th2 Immune Response — PDE4 block reduces cytokine release, source: EMA Staquis overview
• Topical Calcineurin Inhibitors — fellow steroid-sparing topical with burning side effect, source: FDA label
• Topical Corticosteroids — alternative to; no atrophy, source: FDA label
• Ruxolitinib Cream — newer non-steroid topical, US ≥2 y, source: FDA Opzelura label
• JAK Inhibitors — other non-steroid topical class, source: FDA labels
• EASI — −57.5% in infants (uncontrolled), source: CrisADe CARE 1
• POEM — −8.5 points in infants, source: CrisADe CARE 1
• European Medicines Agency — EU licence withdrawn 31 Jan 2022, source: EMA Staquis
• FDA — infant extension approved 23 Mar 2020, source: Drugs@FDA
• Parent Experiences — parent reports (anecdotal), source: round-10 forum threads
• AAD Pediatric Guideline 2026 — strong rec ≥3 months, source: JAAD 2026
• Roflumilast Cream — same PDE4 class, once daily, US ≥2 y, source: FDA ZORYVE label 2026
• Tapinarof Cream — newer steroid-free cream, US ≥2 y, source: FDA VTAMA label 2025