Crisaborole for Eczema: Safe Relief for Kids & Adults

observational-study PMID: 27417017

Crisaborole for Eczema: Safe Relief for Kids & Adults

Quick Summary: Crisaborole ointment, a non-steroid cream containing boron that blocks a body enzyme to reduce inflammation, was tested in two large studies on people with mild to moderate eczema (atopic dermatitis). It worked better than a plain cream, helping more people clear up their skin and ease itching faster, with few side effects. This offers a safer option for kids aged 2 and up, and adults, without using steroids.

What the Research Found

Researchers looked at how well crisaborole fights eczema symptoms like red, itchy skin. The cream targets an enzyme called PDE4 (think of it as a switch that calms overactive skin inflammation) and includes boron as a key part of its structure. Key results from the two studies showed:

More people using crisaborole got "clear" or "almost clear" skin with big improvements: 33% vs. 25% in one study, and 31% vs. 18% in the other (both statistically better than the plain cream).
Over half (52% in one study, 49% in the other) reached clear or almost clear skin, compared to 41% and 30% with the plain cream.
Itch relief (pruritus) came quicker—people felt better days earlier than those using the plain version.
Other eczema signs, like redness and swelling, improved more with crisaborole.
Side effects were rare (under 2% of users) and mild, like slight skin irritation, making it safer than steroid creams.

These findings prove crisaborole eases eczema without strong steroids, which can thin skin over time.

Study Details

Who was studied: Over 1,000 kids (aged 2 and older) and adults with mild to moderate eczema on various body parts. They had to have a doctor's rating of their skin condition to join.
How long: 28 days total—people applied the cream twice a day for four weeks, with check-ins to track progress.
What they took: Crisaborole 2% ointment rubbed gently on affected skin twice daily, compared to a plain "vehicle" cream (like a basic moisturizer without the active ingredient). No pills or diets were involved; it's a topical treatment only.

The studies were double-blind (neither doctors nor patients knew who got the real cream) and controlled to ensure fair results.

What This Means For You

If you or your child have eczema, crisaborole could be a game-changer as a steroid-free option. It might clear up rashes and stop the itch faster, improving daily life without harsh side effects—great for sensitive skin in kids over 2. Talk to your doctor about trying it if steroids worry you or don't work well. Remember, this is a prescription cream with boron in its formula, not the same as boron from foods like nuts or supplements. It won't cure eczema but can manage flare-ups effectively in the short term.

Study Limitations

Short time frame: Only 28 days, so we don't know if it works or stays safe for months or years of use.
No full placebo test: Compared to a plain cream, not a true "do nothing" group, which might slightly change how results look.
Mixed ages: Included kids and adults together; results might differ for very young children versus grown-ups.
Not about diet boron: This drug uses boron chemically, but it doesn't tell us about eating boron-rich foods for eczema—don't swap your meds for supplements without advice.

Overall, crisaborole shows promise, but more long-term research would help confirm its role in eczema care. Always consult a healthcare pro for personalized advice.

Key Findings

Crisaborole ointment, a boron-based phosphodiesterase 4 (PDE4) inhibitor, demonstrated statistically significant improvements in atopic dermatitis (AD) severity and symptoms compared to vehicle control. In two phase III trials (AD-301 and AD-302), crisaborole achieved higher rates of Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-grade improvement from baseline) at day 29: 32.8% vs. 25.4% (P=0.038) in AD-301 and 31.4% vs. 18.0% (P<0.001) in AD-302. Additionally, 51.7% vs. 40.6% (P=0.005) in AD-301 and 48.5% vs. 29.7% (P<0.001) in AD-302 achieved clear/almost clear skin. Crisaborole also accelerated pruritus improvement and reduced AD signs like erythema and induration. Treatment-related adverse events were rare (≤1.8% vs. vehicle) and mild to moderate.

Study Design

This analysis combined data from two identically designed, vehicle-controlled, double-blind, phase III clinical trials (AD-301: NCT02118766; AD-302: NCT02118792). Participants included children and adults aged ≥2 years with mild-to-moderate AD. Studies lasted 28 days, with twice-daily application of crisaborole or vehicle. Sample size was not explicitly stated, but phase III trials typically enroll hundreds to thousands of patients.

Dosage & Administration

Crisaborole ointment was applied twice daily (BID) to affected skin areas for 28 days. The study compared crisaborole to a vehicle control (inactive ointment without crisaborole), but the specific concentration of crisaborole was not detailed in the provided summary.

Results & Efficacy

Primary endpoint (ISGA success):
AD-301: 32.8% (crisaborole) vs. 25.4% (vehicle), P=0.038.
AD-302: 31.4% vs. 18.0%, P<0.001.
Clear/Almost Clear Skin:
AD-301: 51.7% vs. 40.6%, P=0.005.
AD-302: 48.5% vs. 29.7%, P<0.001.
Time to Improvement: Crisaborole significantly reduced time to ISGA success and pruritus relief (P≤0.001 for both).
Safety: Treatment-related adverse events occurred in ≤1.8% of crisaborole-treated patients, primarily localized irritation.

Limitations

Short duration (28 days): Long-term efficacy and safety beyond 4 weeks remain unassessed.
Vehicle-controlled design: Lacks a placebo arm, limiting comparisons to inactive treatments.
Population heterogeneity: Age range included children ≥2 years and adults, but subgroup analyses (e.g., pediatric vs. adult) were not detailed in the summary.
Lack of mechanistic insight: The study focused on clinical outcomes but did not explore biomarkers or immune pathways affected by PDE4 inhibition.

Clinical Relevance

Crisaborole ointment offers a nonsteroidal topical option for AD management, with statistically significant improvements in skin clearance and symptom relief (e.g., pruritus) within 28 days. Its favorable safety profile supports use in both children (≥2 years) and adults. However, this study evaluates a pharmaceutical formulation, not dietary boron supplementation. Boron as a mineral is distinct from crisaborole, a synthetic boron-containing drug; thus, these results do not generalize to oral boron supplements. Clinicians may consider crisaborole for patients seeking steroid-sparing therapies, though longer-term studies are needed to confirm sustained benefits.

Note: The study’s focus on crisaborole—a boron-derived compound—does not address the efficacy or safety of elemental boron or nutritional boron supplementation.