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Ingenol mebutate gel 0.027% effective for larger areas of actinic keratosis

Ingenol mebutate gel 0.027% was superior to vehicle treatment for actinic keratosis on the face, scalp and chest with areas 250 cm².

The double-blind, vehicle-controlled phase 3 trial, accepted for publication in Journal of the American Academy of Dermatology, involved 698 patients with actinic keratosis (AK) lesions on the face, scalp or chest throughout 50 sites in the U.S., Canada and Australia. The researchers aimed to determine the safety and efficacy of ingenol mebutate gel 0.027% on AK areas 250 cm².

Patients were randomly assigned 3:1 to receive IngMeb gel 0.027% (ingenol mebutate, Leo Pharma) or vehicle once daily for 3 consecutive days on the full face, full balding scalp or within a contiguous area of approximately 250 cm² on the chest. A total of 541 patients were treated with IngMeb and 157 with vehicle.

Patient monitoring took place for 8 weeks after the first application and then for an additional 12 months. The primary endpoint was complete AK clearance (AKCLEAR 100) at week 8. Safety was assessed in a targeted sample of 720 patients.

AKCLEAR 100 was 21.4% in the IngMeb group at week 8 compared with 3.4% in the vehicle group (P < .001). In the IngMeb group, AKCLEAR 100 was 15% in those with more than 10 baseline lesions and 30.9% in those with 10 or fewer lesions. AKCLEAR 100 was higher at week 8 in participants who received IngMeb vs. vehicle on the face/chest (23.8% vs. 3.5%) and scalp (12.5% vs. 3.1%). Results at Week 4 for AKCLEAR 100 were comparable with results at week 8.

At 8 weeks, AK lesion count was reduced 75.7% in the IngMeb group vs. 12.7% in the vehicle group (P < .001).

The probability of sustained AK clearance at 12 months was 22.9%.

Global satisfaction scores were significantly higher for those treated with IngMeb than vehicle (P <  .001).

Throughout the 8-week treatment period, 79.8% of patients who received IngMeb reported adverse events compared with 34.7% who received vehicle. The most common reports in the IngMeb group were application site pain and pruritus.

Adverse events were similar between treatment groups during the 12-month follow-up period. The incidence of skin malignancies did not differ between treatment groups throughout the study.

One study limitation was the lack of an active comparator instead of vehicle. – by Abigail Sutton

Disclosures: Hanke reports he has served on advisory boards for Leo Pharma and Genentech, received grants from Leo Pharma, served as an investigator for Athenex, Biofrontera, Endo International and PellePharm, and consulted for Leo Pharma and Sun Pharma. Please see the study for all other authors’ relevant financial disclosures.