Methyl aminolevulinate 16% cream

BackgroundActinic keratoses (AKs) are precancerous lesions that may progress to squamous cell carcinoma (SCC). Photodynamic therapy (PDT) with methyl aminolevulinate (MAL) is an established treatment, often preceded by mechanical curettage to enhance photosensitizer penetration. However, curettage is associated with pain and discomfort, necessitating alternative pretreatment strategies, also applicable in daylight PDT.MethodsThirty-six patients with symmetrical facial AKs were randomized to receive MAL-PDT on two contralateral areas: one pretreated with a 10% urea-based keratolytic compound (UBC) for 14 days and the other untreated (control). Protoporphyrin IX (PpIX) fluorescence, clinical outcomes, cosmetic results, and patient satisfaction were assessed. Statistical analyses included the Wilcoxon, Mann-Whitney, and chi-squared tests (p ≤ 0.05).ResultsThe urea-pretreated group showed significantly higher fluorescence intensity (median: 7 [5-9]) vs. controls (median: 5 [3-6]; **p ConclusionsPretreatment with a 10% UBC enhances PpIX fluorescence and improves efficacy in grade I AKs when compared to no pretreatment. Thus, it provides a non-invasive pretreatment option with good efficacy in thin AKs, along with good patient satisfaction and safety.

Abstract licence: CC BY

IntroductionGiven the increasing incidence of Bowen's disease, treatment leads to a substantial economic burden for healthcare services. There are several treatment options for Bowen's disease, of which surgical excision, 5-fluorouracil (5-FU) and methyl aminolevulinate photodynamic therapy (MAL-PDT) are the most commonly used. Recently, results from a randomized controlled non-inferiority trial showed that 5-FU was non-inferior to excision and was associated with a better cosmetic outcome. MAL-PDT was not shown to be non-inferior to excision. Although 5-FU and MAL-PDT were expected to be cheaper than excision, it remains to be determined whether the potential cost savings compensate for the loss of effectiveness. The aim of this study was to determine the most cost-effective treatment for Bowen's disease when comparing surgical excision, MAL-PDT, and 5% 5-FU cream from a healthcare perspective.MethodsData were collected alongside a randomized controlled trial with 250 patients in the Netherlands. Valuation of treatment costs was based on documented resource use and Dutch cost prices. A cost-effectiveness analysis was performed from a healthcare perspective. The primary outcome was the decremental cost-effectiveness ratio (DCER), expressed as the cost-savings per additional recurrence or residual Bowen's disease. Bootstrap analysis and sensitivity analysis were performed to address uncertainty. This trial is registered with ClinicalTrials.gov number, NCT03909646.ResultsAt 12 months after treatment, the costs for 5-FU cream were significantly lower (EUR 311 [CI: -240 to -378]) and the costs for MAL-PDT were higher (EUR 3 [CI: -74 to 65]) compared to excision. 5-FU cream offers cost savings compared to excision, but is less effective although within the non-inferiority margin of 22%. Our results showed that 5-FU has the highest probability of being cost-effective at willingness to accept threshold values of EUR 2,500 and lower compared to MAL-PDT and surgical excision.Conclusion5-FU cream is a cost-effective treatment at a threshold value of EUR 2,500 and lower when compared to surgical excision and MAL-PDT. Therefore, from a cost-effectiveness point of view, 5-FU is considered the first-choice treatment option for Bowen's disease.

Abstract licence: CC BY