Ingenol mebutate (IngMeb) at a concentration of 0.027% was more effective than vehicle control for promoting clearance of actinic keratosis areas of ≤250 cm2, a phase 3 study in the Journal of the American Academy of Dermatology reports.

Adult patients with a total of 5 to 20 actinic keratosis lesions on the face and/or scalp measuring between 25 cm2 and 250 cm2 or chest about 250 cm2 were enrolled in the study. Participants were randomly assigned to either once-daily IngMeb 0.027% gel (n=541) or vehicle (n=157) for 3 consecutive days on the full face, full balding scalp, or chest.

The primary endpoint was complete clearance of actinic keratosis (AKCLEAR 100; week 8). Secondary endpoints were partial actinic keratosis clearance (AKCLEAR 75), lesion recurrence, patient satisfaction, cosmetic outcome, and safety. The researchers monitored patients for 8 weeks after the first application, as well as an additional 12 months.

At week 8, more patients who received IngMeb achieved AKCLEAR 100 compared with patients who were randomly assigned to vehicle control (21.4% vs 3.4%, respectively; P <.001). In addition, IngMeb was superior to vehicle for achievement of AKCLEAR 75 at week 8 (59.4% vs 8.9%, respectively; P <.001).

At week 4, a greater proportion of patients in the IngMeb group achieved AKCLEAR 75 compared with patients in the vehicle group (59.8% vs 9.2%, respectively; P <.001), and both for the face/chest (62.7% vs 9.3%, respectively; P <.001) and scalp (48.7% vs 8.4%, respectively; P =.005). Also, global satisfaction was higher for IngMeb at week 8 (41.0 points out of 100; P <.001).

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During 12-month follow-up, the researchers found a 22.9% probability of sustained clearance with IngMeb. A higher proportion of patients who received IngMeb vs vehicle experienced more adverse events during the 8-week treatment (79.8% vs 34.7%, respectively).

Lack of an active comparator as well as the lack of accounting for subclinical lesions were limitations of the study. The authors added that “[i]nterpretation of [actinic keratosis]-count data during the 12-month follow-up was complicated by use of concomitant medications or individual lesion treatment.”

The study data found that IngMeb was superior to vehicle as a short-term field treatment for patients with actinic keratosis; the researchers also noted “increased treatment-satisfaction and cosmetic outcomes with IngMeb vs. vehicle.”

Disclosure: Several of the study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Hanke CW, Albrecht L, Skov T, et al. Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp or approximately 250 cm2 on the chest: a phase III randomized controlled trial [published online July 30, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.07.083