New, simplified versus standard photodynamic therapy (PDT) regimen for superficial and nodular basal cell carcinoma (BCC): A single-blind, non-inferiority, randomised controlled multicentre study.

BACKGROUND: Topical photodynamic therapy (PDT) is an approved and widely used treatment for low-risk basal cell carcinoma (BCC), comprising two sessions with an interval of 1 week. Simplification of the treatment course can be cost-effective, easier to organize, and cause less discomfort for the patients. METHODS AND FINDINGS: We performed an investigator-initiated, single-blind, non-inferiority, randomized controlled multicentre study with the objective of investigating whether a simpler and more flexible PDT regimen was not >10% less effective than the standard double PDT in the treatment of primary, superficial, and nodular ≤2 mm-thick BCC and evaluate the cosmetic outcome. With a non-inferiority margin of 0.1 and an expected probability complete response of 0.85, 190 tumours were required in each group. Histologically verified BCCs from seven centres in Norway were randomly assigned (1:1) to either receive a new regimen of single PDT with one possible re-treatment of non-complete responding tumours, or the standard regimen. The primary endpoint was the number of tumours with complete response or treatment failure at 36 months of follow-up, assessed by investigators blinded to the treatment regimen. Intention-to-treat and per-protocol analyses were performed. The cosmetic outcome was recorded. The study was registered with ClinicalTrials.gov, NCT-01482104, and EudraCT, 2011-004797-28. A total of 402 BCCs in 246 patients were included; 209 tumours assigned to the new and 193 to the standard regimen. After 36 months, there were 61 treatment failures with the new and 34 failures with the standard regimen. Complete response rate was 69.5% in the new and 81.1% in the standard treatment group. The difference was 11.6% (upper 97.5% CI 20.3), i.e. > than the non-inferiority margin of 10%. Cosmetic outcomes were excellent or good in 92% and 89% following the new and standard regimens, respectively. CONCLUSIONS: Single PDT with possible re-treatment of primary, superficial, and nodular ≤ 2-mm-thick BCC was significantly less effective than the approved standard double treatment. The cosmetic outcome was favorable and comparable between the two treatment groups.

[Patch testing and nickel allergy]. / Epikutantesting og nikkelallergi.

BACKGROUND: The prevalence of contact allergy varies between populations. MATERIAL AND METHODS: 857 patients were tested for contact allergy (epicutantest; patch test) at the Department of Dermatology, Stavanger University Hospital in 2001 and 2002. Finn Chambers were placed on the upper part of the back, removed after 48 hrs and read after an additional 24 hrs. Positive reactions and other variables were recorded and data were collected retrospectively from journals. RESULTS: The most common allergens were metals such as nickel (nickel chloride; 40% and nickel sulphate; 23%), cobolt (11%) and dichromate (6.5%), fragrance mix (10%) and fragrance indicators such as peru balsam (9.4%), compositae (6.1%) and colophonium 5.3%. 370 (67%) women versus 139 (45%) men were positive for at least one of the allergens in the standard series (odds ratio 2.5 CI 1.83-3.23). 149 of 341 (44%) nickel positive patients had isolated reactions to nickel chloride without reacting to nickel sulphate, while only 11 (3.2%) reacted to nickel sulphate alone. 61/93 (66%) of the cobolt sensitive patients were also sensitive for nickel sulphate (OR: 8.9 CI 5.54-14.12,), while 77 (82%) tested positive for nickel chloride (OR: 9.26 CI 5.29-16.21). INTERPRETATION: We detected a similar prevalence for common allergens as that reported from other skin departments in hospitals in Norway, but a higher average than that presented in other European studies.