A randomized split-scalp study comparing calcipotriol-assisted methyl aminolaevulinate photodynamic therapy (MAL-PDT) with conventional MAL-PDT for the treatment of actinic keratosis

Abstract

CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial.

Efficacy of photodynamic therapy combined with topical interventions for the treatment of actinic keratosis: a meta‐analysis

“…In the study comparing the combination of PDT with calcipotriol ointment with PDT monotherapy, the former approach was perceived as more painful than monotherapy (mean AE SD: 5.40 AE 1.43 and 3.95 AE 0.69, respectively). 30 For the comparison of dl-PDT combined with 5-FU vs. dl-PDT alone, none of the patients reported any of the interventions as painful. 24 Data on pain from the study by Tanaka et al could not be evaluated, because it was indicated per treated lesion and not measured on the VAS.…”

“…Pain as outcome was available from three studies. 24,28,30 However, the results were inconsistently reported. In the study comparing the combination of PDT with calcipotriol ointment with PDT monotherapy, the former approach was perceived as more painful than monotherapy (mean AE SD: 5.40 AE 1.43 and 3.95 AE 0.69, respectively).…”

“…19,24,25 The remaining three studies assessed a combination of PDT with ingenol mebutate 0.015% gel, 16 tazarotene 0.1% gel 17 and calcipotriol ointment, 30 respectively. Six studies assessed PDT monotherapy 17,19,24,25,27,30 and one study diclofenac monotherapy 21 as comparison. The remaining three studies had a threearmed design and investigated both PDT and the topical approach as control interventions 16,26,28 (Table 1).…”

“…Seven studies were identified reporting participant complete clearance rates. 17,19,21,[26][27][28]30 PDT in combination with a topical approach showed significantly higher participant complete clearance rates compared to monotherapy (RR 1.63; 95% CI 1.15-2.33; P = 0.007) ( Fig. 2a).…”

European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas

“…A randomized split‐scalp study compared calcipotriol once day for 15 days prior to conventional MAL‐PDT vs. conventional PDT. Clinical and histological improvement was superior on the calcipotriol‐assisted side (overall AK clearance rates were 92.1% and 82.0%, respectively) with greatest improvement for grade II AKs (90% vs.63%) although pain and also local side‐effects were greater with the combined protocol . A prospective randomized clinical trial using ablative fractional laser‐assisted MAL‐PDT after twice daily topical 0.005% calcipotriol pretreatment for 2 weeks showed a higher rate of complete response of facial AK with the combined treatment (89% vs.80%) and lower recurrence rate at 12 months (5% vs.10%) …”