Sequential daylight photodynamic therapy and ingenol mebutate versus 2 sessions of daylight photodynamic therapy for the treatment of actinic keratosis: An observational, prospective, comparative study.

Background: Field-directed therapy, such as daylight-photodynamic therapy (DL-PDT) or ingenol mebutate (IM), is indicated for multiple actinic keratosis (AK) lesions located on contiguous areas of skin with significant sun damage.

Objective: To compare the efficacy of sequential DL-PDT and IM treatment with that of 2 sessions of DL-PDT in AK patients.

Material And Methods: For this observational, multicenter, prospective study we recruited patients for whom DL-PDT was indicated for the treatment of AK lesions (grades I and II) located on the head. After 1 month of follow-up those who did not achieve a satisfactory clinical response received either a second session of DL-PDT or were treated with IM. Epidemiological and clinical data were collected and analyzed.

Results: Forty-three patients were enrolled (39 male, 4 female). The mean (standard deviation, SD) age was 78 (7.84) years, and the mean (SD) number of AK lesions per patient was 9.58 (1.16). After the first session of DL-PDT, 27 patients (62.8%) required further treatment: 13 (48.1%) received a second session of DL-PDT and 14 (51.9%) were treated with IM. After 1 year of follow-up, lesion clearance rates were higher in patients who received 2 sessions of DL-PDT than those treated with sequential DL-PDT plus IM (75.2%vs 54.6%, p = 0.0013). Local skin reactions were more frequent in the DL-PDT plus IM group than the group treated with 2 sessions of DL-PDT (p = 0.0245).

Conclusions: The combination of DL-PDT plus IM appears to have no synergistic effect in the treatment of field cancerization, and offers no benefits over 2 sessions of DL-PDT monotherapy, although both combinations produced high lesion clearance rates, a good safety profile, excellent cosmetic outcome, and good patient satisfaction.