Crisaborole is used for the topical treatment of mild to moderate Atopic Dermatitis in pediatric patients aged 3 months and older.

Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor that primarily targets the PDE4B subtype, which plays a key role in inflammation. Chemically, it belongs to the phenoxybenzoxaborole class and contains a boron atom that enhances skin penetration and binding activity. By inhibiting PDE4B, crisaborole reduces the release of inflammatory mediators such as tumor necrosis factor alpha (TNF-α), interleukin-12 (IL-12), interleukin-23 (IL-23), and other cytokines involved in immune response and inflammation.

Apply a thin layer of Crisaborole twice daily to affected areas. Crisaborole is for topical use only and not for ophthalmic, oral, or intravaginal use.

In vitro studies using human liver microsomes suggest that, under clinical use conditions, Crisaborole and its metabolite 1 are unlikely to inhibit major cytochrome P450 (CYP) enzymes, including CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. Similarly, studies of metabolite 2 indicate no inhibitory effect on CYP2C19, 2D6, or 3A4 enzyme activity.

Crisaborole may cause allergic reactions at or near the application site, which can sometimes be serious. These reactions may include hives, itching, swelling, and redness. The most common adverse effect is pain at the application site, such as burning or stinging sensations.

Crisaborole: There are no adequate data in pregnant women to determine the risk of major birth defects or miscarriage associated with its use. Animal studies showed no adverse developmental effects when crisaborole was given orally to pregnant rats and rabbits during organ development at exposures up to 3 and 2 times the maximum recommended human dose (MRHD), respectively.

Regarding lactation, there is no available information on whether crisaborole is present in human breast milk. Although it is systemically absorbed, the absence of clinical data during breastfeeding makes it difficult to determine the potential risk to a breastfed infant.

Hypersensitivity reactions, including contact urticaria, have been reported in patients treated with Crisaborole. If signs or symptoms of hypersensitivity develop, treatment should be discontinued immediately and appropriate medical management should be initiated.

Topical anti-inflammatory preparations

Store Crisaborole at a temperature not exceeding 30°C. Protect from light and keep out of reach of children.