Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0·015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp

Summary

This study from Germany, Spain and the U.K. compared the effectiveness of two gel treatments for actinic keratosis (AK) on the face or scalp. An AK is a small, spiky, scaly or sandpaper-like area of sun damage on the skin surface. A very small proportion progress to squamous cell skin cancer. Creams or gels rubbed into the skin are recommended when a large area such as the entire scalp is affected by multiple AKs. Ingenol mebutate 0·015% gel (IngMeb) and diclofenac sodium 3% gel (DS) were compared in 502 patients, mostly male and almost all white-skinned. IngMeb was applied once daily for three consecutive days and DS twice daily for 90 days (the normal recommendations for use). Patients using IngMeb were allowed to apply it for a second three-day period if they had new or residual AKs at week 8, which meant that more than half this group used IngMeb twice. Looking at the treated area at week 17 - approximately four weeks after finishing the course of DS, nine weeks after the second course of IngMeb (if used), and 17 weeks after the first (or only) course of IngMeb - almost twice as many patients in the IngMeb group were completely clear of AKs than in the DS group. Even if they had not disappeared completely, more AKs had partially cleared up, and the total number had decreased significantly more, in the IngMeb group. Side effects were mild or moderate, most commonly redness where either gel was applied.