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.

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    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.
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