Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm on the chest: A phase 3 randomized controlled trial.

BACKGROUND

Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm or less; some patients require treatment of larger fields.

OBJECTIVE

To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm during an 8-week initial assessment period and extended 12-month follow-up.

METHODS

This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm) or chest (approximately 250 cm). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety.

RESULTS

IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified.

LIMITATIONS

Localized skin responses hindered maintenance of double-blinding.

CONCLUSIONS

IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm. The safety profile of IngMeb was as expected.