Short incubation fractional CO2 laser-assisted photodynamic therapy vs. conventional photodynamic therapy in field-cancerized skin: 12-month follow-up results of a randomized intraindividual comparison study.

BACKGROUND: Topical methyl aminolevulinate photodynamic therapy (MAL-PDT) with 3 h incubation is recommended as a field directed treatment. Skin pretreatment with ablative CO2 fractional laser (AFXL) prior to MAL-PDT enhances drug penetration and could minimize incubation time. OBJECTIVES: To evaluate and compare the safety and the preventive effect in the development of new non-melanocytic skin cancers (NMSCs) of AFXL-assisted MAL-PDT with 1-h incubation with that of conventional MAL-PDT in patients with clinical and histological signs of field cancerization. METHODS: Forty-two patients with two mirror cancerized areas of face or scalp were randomized to field treatment with 1-h incubation AFXL-assisted PDT or conventional PDT (CPDT). All patients underwent two treatment sessions 1 week apart. Irradiation was performed using a red light-emitting diode lamp at 37 J/cm2 . Patients were followed up at 3, 6, 9 and 12 months for the evaluation of development of new NMSCs lesions. RESULTS: All patients completed the study. There was no statistically significant difference with respect to the total number of new actinic keratoses at any point of follow-up as well as to the mean time of occurrence of new lesions between treatment fields. Both treatment regimens were safe and well tolerated. CONCLUSION: Ablative CO2 fractional laser pretreatment may be considered as an option for reducing photosensitizer occlusion time while providing the same preventative efficacy as CPDT in patients with field-cancerized skin.

Conventional vs. daylight photodynamic therapy for patients with actinic keratosis on face and scalp: 12-month follow-up results of a randomized, intra-individual comparative analysis.

INTRODUCTION: Daylight PDT (DLPDT) is a new PDT procedure. Several trials demonstrate that DLPDT achieves similar response rates with conventional PDT (CPDT) in the treatment of non-hyperkeratotic actinic keratoses (AKs) in a nearly painless way. It seems that DLPDT represents a more convenient and equally effective treatment modality. Data on long-term efficacy of DLPDT are limited. OBJECTIVE: To compare short- and long-term efficacy, safety and tolerability of DLPDT with that of CPDT in face and scalp AKs. METHODS: The study, an intra-individual right-left comparison study, was conducted in three centres in North, Center and South Greece. Eligible patients received either DLPDT or CPDT randomly allocated to alternate sides of face or scalp. Patients were evaluated at baseline, 3 and 12 months after treatment. Assessments included lesion response at 3 and 12 months, PDT-associated pain during PDT session, local skin reactions 3 days after treatment as well as patients' preference 3 months after treatment. RESULTS: A total of 46 patients completed the study. Three months after treatment, the overall lesion complete response rate was 78% for DLPDT and 80.6% for CPDT. At the 12-month follow-up, response rate decreased to 71.8% and 73.7% for DLPDT and CPDT accordingly. Regarding response based on lesion grade, response rates obtained in grade-I lesions were higher with DLPDT, while treatment with CPDT resulted to higher rates of cured grade-II lesions at both follow-up visits. Results were not supported by statistical significance. DLPDT was associated with significantly lower pain and reduced severity of local skin reactions. Patients' preference favoured DLPDT. CONCLUSIONS: Our study demonstrated that DLPDT is similar to CPDT in terms of long-term efficacy and recurrence rates in the treatment of face and scalp AKs. DLPDT demonstrated a better tolerability profile as it was associated with lower pain and less severe adverse events.

Daylight photodynamic therapy vs. Conventional photodynamic therapy as skin cancer preventive treatment in patients with face and scalp cancerization: an intra-individual comparison study.

BACKGROUND: Individuals with medical history of non-melanoma skin cancers (NMSCs) usually develop multiple and/or recurrent malignant lesions around the site of the primary neoplasm. The latter represents the clinical expression of the 'field cancerization' theory; supporting the presence of multiple malignant clones of dysplastic keratinocytes over the entire epithelium that potentially can progress into clinical lesions. Taking into consideration that the burden of NMSCs on public health and health-care cost is high, adequate control of recurrences and management of field change is challenging. OBJECTIVES: To compare the safety and efficacy of daylight photodynamic therapy (DL-PDT) vs. conventional photodynamic therapy (C-PDT) in the prevention of occurrence of new NMSCs in patients with clinical and histological signs of actinic field damage. METHODS: Twenty-six patients, with personal history of NMSCs on the face or scalp and actinic keratosis (AK) on the same fields, were randomized for DL-PDT on one side and C-PDT on the other. For a 12-month period, individuals were clinically evaluated for development of new NMSCs. RESULTS: The total number of new AKs and the mean time of their development did not significantly differ between the treated sides. Local adverse events were more intense with C-PDT, and patients' preference was more for DL-PDT compared to C-PDT. CONCLUSIONS: The current findings suggest equal preventive potential of DL-PDT vs. C-PDT against the formation of new NMSCs in patients exhibiting actinic field damage.

Photodynamic therapy vs. imiquimod 5% cream as skin cancer preventive strategies in patients with field changes: a randomized intraindividual comparison study.

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. RESULTS: Forty-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. CONCLUSIONS: MAL-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.