Five-year follow-up of a randomized, prospective trial of topical methyl aminolevulinate photodynamic therapy vs surgery for nodular basal cell carcinoma.

OBJECTIVE: To compare 5-year lesion recurrence rates in primary nodular basal cell carcinoma treated with topical methyl aminolevulinate photodynamic therapy (PDT) or simple excision surgery. DESIGN: Prospective, randomized, multicenter study. SETTING: University hospital dermatology departments. PATIENTS: A total of 97 patients, 50 with 53 lesions treated with methyl aminolevulinate PDT and 47 with 52 lesions treated by excision surgery, were included in the per protocol analysis. Of the lesions treated with methyl aminolevulinate PDT and surgery, 49 and 52, respectively, showed complete clinical response at 3 months after treatment and were observed for long-term outcome evaluation. INTERVENTIONS: Topical methyl aminolevulinate cream, 160 mg/g, applied for 3 hours before illumination (75 J/cm(2) of red light at 570 to 670 nm) on 2 or 4 occasions (12 [23%] of 53 lesions); or excision surgery. MAIN OUTCOME MEASURES: Histologically confirmed lesion recurrence, sustained lesion complete response rate (time-to-event analysis), and investigator assessment of cosmetic outcome, 5 years after the last treatment. RESULTS: At 5 years, recurrence was documented in 7 (14%) of 49 lesions (95% confidence interval [CI], 6%-27%) treated with methyl aminolevulinate PDT vs 2 (4%) of 52 lesions (95% CI, 1%-13%) treated with excision surgery (P = .09). Estimated sustained lesion complete response rates were 76% (95% CI, 59%-87%) and 96% (95% CI, 84%-99%), respectively (P = .01). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome: 27 (87%) of 31 patients (95% CI, 70%-96%) vs 19 (54%) of 35 patients (95% CI, 37%-71%) (P = .007). CONCLUSIONS: Long-term follow-up indicates superior efficacy of surgery to methyl aminolevulinate PDT in nodular basal cell carcinoma. However, methyl aminolevulinate PDT is also an effective treatment for this indication and exhibits a more favorable cosmetic outcome.

Frequency of bacteria, Candida and malassezia species in balanoposthitis.

Balanoposthitis is an inflammatory disorder of the prepuce and glans penis. Microbes involved in balanoposthitis have been investigated, but no single study has covered the growth of both bacteria, Candida and Malassezia. We report here the prevalence of these microbes in 100 patients with balanoposthitis and in 26 control patients. Among patients with balanoposthitis there was a significantly higher frequency of positive cultures than in the control group (59% and 35%, respectively, p<0.05). In the balanoposthitis group Staphylococcus aureus was found in 19%, group B streptococci in 9%, Candida albicans in 18% and Malassezia in 23% of patients. In the control group S. aureus was not found at all, whereas C. albicans was found in 7.7% and Malassezia in 23% of patients. Different microbes did not correspond with distinct clinical manifestations. In summary, we report increased frequency of microbes, specifically S. aureus, in the area of the prepuce and glans penis in balanoposthitis.