A randomized clinical trial of photodynamic therapy with methyl aminolaevulinate vs. diclofenac 3% plus hyaluronic acid gel for the treatment of multiple actinic keratoses of the face and scalp

Summary Background A gel containing diclofenac and hyaluronic acid (DHA) and photodynamic therapy with methyl aminolaevulinate (MAL‐PDT) are widely used treatments for actinic keratoses (AKs). Objectives The aim of this single‐centre, open‐label, prospective, nonsponsored, randomized controlled clinical trial was to compare the treatment results and cost‐effectiveness of MAL‐PDT and DHA. Methods Patients with multiple AKs of the face and scalp were randomized to receive MAL‐PDT or DHA. After 90 days, the overall complete remission (CR) rate of patients and the CR rate of lesions according to thickness score were assessed, and patients and an investigator scored the cosmetic outcome. In addition, patients scored their overall satisfaction with the treatment. Patients with CR of all lesions were followed up for 12 months. Results Two hundred patients with a total of 1674 AKs were enrolled. The lesion CR rates at 3 months were 85·9% with MAL‐PDT and 51·8% with DHA (P