To compare the efficacy, tolerability, and cosmetic outcome of photodynamic therapy (PDT) using topical methyl aminolevulinate with cryotherapy or topical fluorouracil for treatment of squamous cell carcinoma in situ. Design: Randomized, placebo-controlled study, with follow-up at 3 and 12 months after last treatment. Setting: Forty outpatient dermatology centers in 11 European countries. Patients: Random sample of 225 patients with histologically confirmed squamous cell carcinoma in situ (lesion size, 6-40 mm) and no evidence of progression. Interventions: Treatment with PDT with methyl aminolevulinate (160 mg/g; n=96) or matching placebo cream (n=17), cryotherapy (n=82), or topical fluorouracil (5% cream; n=30). Methyl aminolevulinate or placebo cream was applied for 3 hours before illumination with broadband red light (75 J/cm 2 , 570-670 nm). Treatment was repeated 1 week later. Cryotherapy was performed with liquid nitrogen spray. Fluorouracil was applied for 4 weeks. Lesions with a partial response at 3 months were retreated. Main Outcome Measures: Clinically verified complete response of lesions; blinded and on-site assessment of cosmetic outcome (4-point rating scale). Results: At 12 months, the estimated sustained lesion complete response rate with methyl aminolevulinate PDT was superior to that with cryotherapy (80% vs 67%; odds ratio, 1.77; 95% confidence interval, 1.01-3.12; P=.047), and better than that with fluorouracil (80% vs 69%; odds ratio, 1.64; 95% confidence interval, 0.78-3.45; P=.19). Cosmetic outcome at 3 months was good or excellent in 94% of patients treated with methyl aminolevulinate PDT vs 66% with cryotherapy and 76% with fluorouracil, and was maintained at 12 months. Conclusion: Methyl aminolevulinate PDT is an effective treatment option for squamous cell carcinoma in situ, with excellent cosmesis.

We conclude that treatment with the recently available biological agents might be associated with the formation of eruptive naevi. Although positive evidence for the occurrence of malignant pigmented lesions is lacking, alertness to the development of eruptive melanocytic naevi during treatment with biological agents is indicated.

Narrow band UVB is succeeding psoralen and UVA irradiation as the main treatment of vitiligo vulgaris in several European countries. Vitamin B12 and folic acid deficiency in some vitiligo patients has prompted researchers to investigate the efficacy of these vitamins in the treatment of vitiligo. In the present controlled study we investigated the value of narrow band UVB phototherapy in the treatment of vitiligo and the possible additive effect of vitamin B12 and folic acid. Twenty-seven patients with long-term stable vitiligo were included and randomized in a "UVB only" (UVB) or "UVB combined with vitamin B12 and folic acid" (UVB+) group. Patients were irradiated thrice weekly for one year, whilst repigmentation was carefully monitored. In 92% (25/27) of the patients up to 100% repigmentation was seen. Repigmentation was notable in lesions on the face, neck and throat, lower arm, chest, back and lower legs, whilst repigmentation on the hands, wrists, feet and ankles proved to be minimal. Maximum repigmentation rates did not differ significantly between the UVB group and the UVB+ group. Our study reconfirms that narrow band UVB phototherapy is an effective treatment for vitiligo and shows that co-treatment with vitamin B12 and folic acid does not improve the outcome of treatment of vitiligo with narrow band UVB phototherapy.

Since Fischer reported on the superiority of 313 nm UVB compared with broad band UVB in the treatment of psoriasis, narrow band UVB has become the main phototherapeutical modality in several countries. There is some discussion about the safety and photobiological effects of narrow band UVB. In the present study, narrow and broad band UVB have been compared with respect to parameters for photodamage and inflammation. Fourteen healthy volunteers were randomized in two groups. Both groups were irradiated with three minimal erythema doses (MED) of narrow or broad brand UVB, respectively. Before and 4, 24 and 48 h after irradiation, 6 mm biopsies were taken from immunohistochemical analysis of p53, apoptosis and p16 (photodamage parameters) and T-cells, polymorphonuclear leukocytes (PMN) and Langerhans' cells (inflammatory cells). Mean MED for narrow band UVB was 8.125 times higher than broad band UVB. Significant changes in expression were seen for all parameters except for p16. P53, apoptosis, T-cells and PMN increased, while Langerhans' cell count decreased significantly. No significant differences were seen between the narrow band UVB. In conclusion, following irradiation of three MED narrow band UVB and broad band UVB safety parameters for carcinogenesis and inflammation were induced to the same extent. As narrow band UVB is more effective than broad band UVB, the present study suggests superiority of narrow band UVB as a treatment with a better benefit risk ration.

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