Crisaborole Ointment May Be Better Tolerated than Other Topical Treatments in Patients with Atopic Dermatitis

Atopic dermatitis and other inflammatory skin diseases like psoriasis often occur in patients who are also more sensitive to treatment-related skin irritation; in an attempt to uncover a safer treatment alternative, researchers recently conducted a study on the tolerability of crisaborole topical ointment, 2%. Their results were published in the American Journal of Clinical Dermatology last week.

The study was randomized, double-blind, vehicle-controlled and involved 32 healthy subjects (ie, the subjects did not have an inflammatory skin disease). The crisaborole or vehicle/placebo ointment was applied daily, for 21 days, to sensitive and thin-skinned parts of the body, such as the face, hairline, genitals, and other extensor and intertriginous areas. These locations were selected as they are more frequently involved in cases of AD and other inflammatory skin diseases.

According to researchers: “In infants and young children, the face, neck, and extensor skin areas are frequently involved, while older children and adults often present with flexural fold involvement of the extremities (ie, antecubital and popliteal fossae). In addition to disease involvement in sensitive skin areas, patients with AD have higher skin sensitivity (eg, stinging, burning, itching, pain) to cosmetics and environmental factors.”

Topical corticosteroids, while effective in treating AD, can have adverse effects when applied to thin-skinned areas; topical calcineurin inhibitors, on the other hand, carry the risk of application-site reactions as well as boxed warnings that cite cases of malignancy. “Therefore,” say researchers, “effective and well-tolerated topical treatment alternatives that can be safely applied to the face and other thin and sensitive skin areas are needed for inflammatory skin diseases such as AD and psoriasis.”

Crisaborole topical ointment, 2%, is a nonsteroidal, anti-inflammatory, phosphodiesterase 4 inhibitor. Phase II and III studies involving crisaborole have already been conducted on patients with AD, and these have supported the treatment as safe, effective, and well-tolerated. This particular study aimed to evaluate crisaborole’s effect on skin areas known to be particularly thin and/or sensitive.

Of the 32 subjects, 24 of them were treated with crisaborole and 8 were treated with a vehicle/placebo ointment. Researchers found that “98.8 % of all assessments for crisaborole ointment and vehicle ointment had a local tolerability grade of 0 (i.e., no evidence of signs/symptoms of irritation), 0.85 % were grade 1, and 0.1 % (10 of 8697 total assessments) had a grade >1, the majority of which were resolved back to 0 by the next study visit.”

These findings demonstrate that crisaborole is well-tolerated on thin and sensitive skin areas in healthy volunteers, suggesting that future studies ought to confirm the same in patients with AD and other inflammatory skin diseases.