Article

Results of an investigator-initiated single-blind split-face comparison of photodynamic therapy and 5% imiquimod cream for the treatment of actinic keratoses.

McKay-Dee Dermatology, Ogden, Utah, USA.
Dermatologic Surgery (Impact Factor: 1.56). 02/2012; 38(5):722-7. DOI: 10.1111/j.1524-4725.2012.02340.x
Source: PubMed

ABSTRACT Topical photodynamic therapy (PDT) with aminolevulinic acid (ALA) and 5% imiquimod cream are effective therapies for the treatment of actinic keratoses (AKs), but no split-face studies directly comparing these treatment options are available in the literature.
To compare the efficacy and tolerability of ALA-PDT and imiquimod 5% cream for the treatment of AKs.
Sixty-one patients were enrolled from the Salt Lake City Veterans Affairs Hospital; 51 completed the study and were included in the analysis. All patients were randomized to receive half of a sachet of imiquimod 5% cream twice weekly on half of their face and two sessions of PDT with 20% solution of ALA applied for 1 hour to the other side of the face. The 75% AK clearance rate was 34.6% for ALA-PDT and 25% for imiquimod 5% cream (p = .30). The mean reduction in AK count was 59.2% for ALA-PDT and 41.4% for imiquimod 5% cream (p = .002). Dermatology Life Quality Index (DLQI) scores were assessed for each treatment modality at week 4 and were 1.95 and 1.38, respectively (p = .20).
The sample size was small, and patients applied a small amount of imiquimod 5% cream (half a sachet) to a large surface area.
There was no statistically significant difference in treatment response when the 100% or 75% clearance rate cutoff was used, but our secondary outcome suggests that two sessions of ALA-PDT is superior to imiquimod 5% cream for the treatment of AKs. There was no statistically significant difference in effect on quality of life as assessed using the DLQI.

0 Bookmarks
 · 
78 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: The efficacy of photodynamic therapy (PDT) using topical 5-aminolevulinic acid (ALA) for the treatment of actinic keratosis (AKs) is lower on the distal extremities compared with the head and neck areas. The strong temperature dependence of porphyrin synthesis in biologic tissue suggests that heating skin during incubation may improve the efficacy of PDT, particularly in areas where biologic temperatures are naturally lower. The aim of this study was to evaluate the efficacy and tolerability of temperature-modulated PDT for the treatment of AKs on the extremities.
    Dermatologic Surgery 09/2014; · 1.56 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: To determine whether field photodynamic therapy (PDT) of actinic keratoses using a novel preparation of 5-aminolevulonic acid (novel ALA) results in fewer subsequent invasive skin cancers developing on the face of individuals with previous facial cutaneous malignancy in a prospective randomized controlled trial. Intervention patients received two treatments of novel ALA 2 weeks apart. Controls were observed. Patients were followed up with biopsy of any suspicious lesions for 3 years. The trial was suspended early because of problems with trial governance and the reporting of severe adverse events. Sixty-four patients who were recruited at that time at one center were monitored. Their average age was 71, and 57% were male. Patients were randomized to intervention (n = 34) or observation (n = 29). Over the subsequent 3 years, 13 intervention patients (38%) developed 30 new cutaneous malignancies in the field treated, and 11 control patients (38%) developed 22 new malignancies. Some intervention patients experienced prolonged adverse events, including permanent scarring. Novel ALA made no difference in the likelihood of new malignancies developing. The risks without benefit of this novel ALA are troubling. Lack of efficacy and safety of novel ALA cannot be extrapolated to other PDT products.
    Dermatologic Surgery 04/2014; 40(4):412-9. · 1.56 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Actinic damage is responsible for the development of multiple, recurrent non-melanoma skin cancers (NMSCs), including actinic keratoses (AKs). Photodynamic therapy (PDT) and imiquimod cream (IMIQ) 5% are recommended as field-directed treatment options.Objectives To compare efficacy and safety of methyl aminolevulinate (MAL)-PDT vs. IMIQ 5% in the prevention of new NMSCs development patients with field changes.Methods Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side, and IMIQ 5% on the mirror field. The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events and patient preference.ResultsForty-four patients completed the study. MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up. Both treatment regimens were safe and well tolerated. Patients' preference based on the procedure, response rates and future choice favoured MAL-PDT.ConclusionsMAL-PDT and IMIQ 5% are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes. MAL-PDT treatment appears to be superior in terms of patients' preference.
    Journal of the European Academy of Dermatology and Venereology 04/2014; · 2.69 Impact Factor