Table 2.
Characteristics of randomised studies assessing the efficacy and/or safety of daylight photodynamic therapy (PDT) with methyl aminolevulinate (MAL) in subjects with actinic keratoses (AK) of the face or scalp
| Publication country/region | Study design treatment arms | Number enrolled (completed) mean age, sex, AK severity | Mean daylight exposure time | Mean lesion response rate (reduction at 3 months from BL) | Mean maximal pain scores ± SD during daylight exposure † |
|---|---|---|---|---|---|
|
Wiegell et al. 200811
northern Europe |
RCT, SB, single centre, split‐face daylight PDT vs c‐PDT |
n = 30 (29) 78 years, 77% M AK (severity NR) |
150 min (defined in protocol) |
Daylight PDT vs c‐PDT: 79 vs 71% (P = 0.13) |
Daylight PDT vs c‐PDT: 2.0 ± 1.9 vs 6.7 ± 2.2; P < 0.001 |
|
Wiegell et al. 200916
northern Europe |
RCT, DB, single centre, split‐face 16 vs 8% MAL |
n = 30 (29) 71 years, 87% M Thin AK ‡ |
244 min |
16% MAL vs 8% MAL: 77 vs 80% (P = 0.37) |
16% vs 8% MAL: 3.7 ± 2.4 vs 3.6 ± 2.4; P = 0.74 |
|
Wiegell et al. 2011, 201214, 15
northern Europe |
RCT, multicentre 2 vs 3 h § daylight exposure |
n = 145 (142), including 120 (119) grade 1 grade 1: 72 years, 81% M Mild to thick AK ‡ |
2 h: 131 min 3 h: 187 min |
2 vs 3 h, grade 1: 77 vs 75% (P = 0.57) 2 and 3 h pooled: grade I: 76% (n = 120 patients) ‡ grade II: 61% (n = 127 patients) ‡ grade III: 49% (n = 67 patients) ‡ |
2 vs 3 h, grade 1: 1.3 ± 1.5 vs 1.3 ± 1.5; P = 0.94 All patients: min 0, max 3 |
|
Rubel et al. 201413
Australia |
RCT, SB, multicentre, noninferiority (efficacy), superiority (safety), split‐face daylight PDT vs c‐PDT |
n = 100 (92) 70 years, 75% M Mild AK with or without moderate AK ‡ |
120 min (defined in protocol) |
daylight PDT vs c‐PDT: 89 vs 93% (noninferior: 95% CI −6.8 to −0.3) 96% of mild lesions maintained complete response after 24 weeks |
daylight PDT vs c‐PDT: 0.8 ± 1.2 (min 0, max 5) vs 5.7 ± 2.3 (min 0, max 10), P < 0.001 |
†Mean maximal pain score based on a numerical rating scale from 0 (no pain) to 10 (extreme pain). ‡The thickness of each lesion was graded according to Olsen et al. 19913 where grade I (mild) = slightly palpable AK, more easily felt than seen, grade II (moderate) = easily felt, and grade III (thick) = very thick or obvious AK. §Total time of exposure to daylight following application of MAL cream. BL, baseline; c‐PDT, conventional photodynamic therapy with red light‐emitting diode light; CI, confidence interval; DB, double‐blind; M, male; max, maximum; min, minimum; NR, not reported; RCT, randomised controlled trial; SB, single‐blind.