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Background: Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK)., Objectives: To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs., Methods: This nonsponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy., Results: In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0·008). In total, BF-200 ALA cleared 299/375 AKs (79·7%) and MAL 288/392 (73·5%) (P = 0·041). The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven on the MAL side and 23 displayed no difference (P = 0·001). The cosmetic outcome was excellent or good in > 90% of cases with both photosensitizers (P = 1·000). The cost-effectiveness plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA., Conclusions: Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL., (© 2018 British Association of Dermatologists.)

Background: Daylight-mediated photodynamic therapy (DL-PDT) using methyl-5-aminolaevulinate (MAL) is effective for thin, grade I, actinic keratoses (AK). There are no published studies of other photosensitizers used in DL-PDT., Objectives: To compare the efficacy and adverse effects of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) with MAL in DL-PDT of grade I-III AKs., Methods: In 13 patients, 177 AKs were randomized symmetrically for a split-face prospective observer-blinded study and received either BF-200 ALA or MAL DL-PDT. Grade I AKs were treated once and grade II-III AKs twice with a 0·25-mm layer of photosensitizer precursors. Pain was assessed during and after the daylight exposure. Efficacy at 3 months was assessed clinically and histologically., Results: BF-200 ALA cleared 71/84 (84·5%) and MAL 69/93 (74·2%) of the AKs (P = 0·099), all grades responding equally, but with new AKs appearing during follow-up (n = 4, BF-200 ALA; n = 8, MAL). In per patient half-face analysis BF-200 ALA showed significantly higher clearance rates for grade I AKs than did MAL (P = 0·027), but for thicker grades, clearance was equal (P = 0·564). BF-200 ALA and MAL treatments resulted in 61·5% and 38·5% complete histological clearance (P = 0·375), respectively. p53 expression decreased by 54·4% and 33·7%, respectively (P = 0·552). Both treatments were nearly painless with similar adverse reactions and no difference in patient preference., Conclusions: BF-200 ALA showed a trend towards improved efficacy results compared with MAL. Thicker lesions in both groups responded when treated repeatedly. Importantly, a thin 0·25-mm layer of the photosensitizer precursors was sufficient, which may lead to lower expense., (© 2014 British Association of Dermatologists.)

Background: Field cancerization denotes subclinical abnormalities in a tissue chronically exposed to UV radiation. These abnormalities can be found surrounding the clinically visible actinic keratoses., Objectives: The aim of this study was to test the feasibility of a hyperspectral imaging system in the detection of multiple clinical and subclinical AKs for early treatment of the affected areas., Materials and Methods: Altogether 52 clinical AKs in 12 patients were included in this study. In six patients digital photos were taken of the naive AKs, and again after methylaminolevulinate(MAL)-fluorescence diagnosis which was used to teach HIS to find subclinical lesions. After 2-3 days when the MAL had vanished, the hyperspectral images were taken. Biopsies were taken from clinical AKs, healthy-looking skin and several suspected subclinical AKs. In the other six patients digital and hyperspectral images were taken of the naive AKs followed by one biopsy per patient., Results: HIS detected all clinically visible 52 AKs and numerous subclinical lesions. The histopathology of the 33 biopsied lesions were concordant with the HIS results showing either AK (n = 28) or photodamage (n = 5). Of the 28 histopathologically confirmed AKs, 16 were subclinical. A specific diffuse reflectance spectrum of an AK and healthy skin was defined., Conclusion: The hyperspectral imaging system offers a new, non-invasive method for early detection of field cancerization. Lasers Surg. Med. 45:410-417, 2013. © 2013 Wiley Periodicals, Inc., (© 2013 Wiley Periodicals, Inc.)

A trioxysalen bath is a safe alternative to systemic 8-methoxypsoralen in long-term psoralen plus ultraviolet A (PUVA) treatment. The kinetics of its main side-effect, the strong phototoxicity, has not been thoroughly studied. This study determined the degree and persistence of phototoxicity after a single 10 min bath at a trioxysalen concentration of 0.33 mg/l. The buttock skin of 16 healthy volunteers was irradiated with UVA 10 min, and 1, 3, 9 and 24h after the bath. The minimal phototoxic dose (MPD) was assessed 48, 72 and 96h after the bath. In general, the 96 h reading showed the lowest values of MPD; for example, a median of 0.14 J/cm2 (95% confidence interval 0.10-0.14 J/cm2) at sites irradiated 10 min after the bath. The values increased progressively with later irradiation, and the maximum dose applied, 18.32 J/cm2, failed to produce any redness when irradiation was given 24 h after the bath. Substantial phototoxicity persists up to at least 9h after the trioxysalen bath, making it wise for patients to avoid sunshine for at least the rest of the day.

Background: Long-term use of topical trimethylpsoralen (TMP) psoralen bath plus ultraviolet A (bath PUVA) is considered safe with regard to the risk of skin cancer. However, the potential for severe phototoxicity limits its use., Objectives: To study the effect of dilution of the TMP bath on the minimal phototoxic dose (MPD)., Methods: Fifteen volunteers participated in the study. The MPD tests were performed for three TMP concentrations: 0.33 mg L-1, 0.1 mg L-1 and 0.033 mg L-1 at 2-week intervals. Geometric UVA dose series increasing by a factor of radical2 were used for the testing on the previously unexposed buttock skin. The MPD72 h was assessed at 72 h from the bath., Results: For the highest TMP concentration of 0.33 mg L-1, the median MPD72 h was 0.14 J cm-2 (95% confidence interval (CI), 0.10-0.14 J cm-2). For the diluted TMP bath concentration of 0.1 mg L-1, the median MPD72 h increased to 0.29 J cm-2 (95% CI, 0.2-0.41 J cm-2) and for 0.033 mg L-1 to 0.81 J cm-2 (95% CI, 0.57-1.15 J cm-2), respectively. Thus, diluting the labelled concentration of 0.33 mg L-1 1 : 10 increased the median MPD72 h 5.6-fold., Conclusions: With regard to the safety and practicality of the TMP bath PUVA, the lower concentrations of TMP may be of clinical importance, and this needs to be validated in future controlled clinical trials.