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.

Curettage and multiple needle puncture-assisted methyl-aminolaevulinate photodynamic therapy of basal cell carcinoma.

The use of skin puncture techniques may facilitate the delivery of topically applied drugs for photodynamic therapy (PDT). The main aim of this prospective study was to evaluate the efficacy and cosmetic outcome of curettage, multiple needle puncture, and methyl-aminolaevulinate (MAL)-PDT in basal cell carcinoma (BCC). All tumours received curettage and 15-20 needle punctures/cm2 before two sessions of MAL-PDT. The primary endpoint was clinically observed recurrence at follow-up. Overall, 284 patients with 299 histologically verified BCC (70 superficial, 190 nodular, 35 aggressive, and four not subtyped) were included. Following PDT, the mean follow-up period was 6.7 months. After follow-up, 274 (92%) of 299 treatment sites showed no clinical signs of recurrence, with >90% complete response for each BCC subtype. The cosmetic outcome was rated as excellent/good in 81% of cases. Good short-term treatment results were shown following curettage, multiple needle puncture, and MAL-PDT for BCC of different subtypes.

Occupational skin diseases from 1997 to 2004 at the Department of Dermatology, University Hospital of Northern Norway (UNN): an investigation into the course and treatment of occupational skin disease 10-15 years after first consultations with a dermatologist.

OBJECTIVES: We investigate the impact of occupational skin disease consultations among outpatients at the Dermatological Department, University Hospital, Northern Norway. STUDY DESIGN: From 1997 until 2004, 386 patients with occupational skin disease were examined and given advice on skin care, skin disease treatment, skin protection in further work, and on the legal rights of patients with this disease. Ten to fifteen years later, we wanted to look at these patients in terms of their work situation, the current status of their disease, the help they received from the labour offices, and their subjective quality of life. MATERIAL AND METHODS: In the autumn of 2011 until the spring of 2012, a number of the patients examined in the period from 1997 to 2004 were selected and sent a questionnaire, which they were asked to answer and return, regarding their work situation and the progress and current status of their occupational disease. RESULTS: A total of 153 (77%) patients answered the questionnaire; 71% of these patients were still in work, and further 15% had old-age retired, 13% were working until then; 16% had retired early because of disability; 54% had changed jobs because of their occupational skin disease; 86% of the patients indicated that the skin disease had improved since our previous investigation. CONCLUSIONS: Our investigation into patients with occupational skin disease documented that the majority of patients who had received professional dermatological consultation and intervention offers were still in the labour market and had good control of their skin disease 10-15 years later. We discovered that 71% of the patients were still employed. 13% had remained in work until they became old age pensioners. Only 16% dropped out of work because of disability. These high percentages may indicate that our intervention has contributed positively to patients' work conditions and the course of their skin disease.

Clinical and economic impact of etanercept in real-life: a prospective, non-interventional study of etanercept in the treatment of patients with moderate to severe plaque psoriasis in private dermatologist settings (ESTHER).

BACKGROUND: Real-life data on the therapeutic effectiveness and costs of etanercept are scarce. OBJECTIVES: To assess the clinical and economic impact of etanercept in patients with psoriasis in Denmark and Norway. MATERIAL & METHODS: This prospective, non-interventional study in a private dermatologist care setting in Denmark and Norway included patients ≥18 years with moderate to severe plaque psoriasis, selected for treatment with etanercept. Assessments during 1 year from etanercept initiation included Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area and Severity Index (SAPASI) and adverse events. Direct and indirect costs were calculated. RESULTS: 163 subjects were enrolled. Baseline mean SAPASI was 19.1 . Proportion of patients with ≥50% decrease in SAPASI from baseline was 85% and 81% at weeks 24 and 52. DLQI decreased significantly from 11.4 (7.0) to 3.2 (4.3) and 3.7 (4.6) at weeks 24 and 52. Total annual costs increased from 78,000 to 286,000 DKK (p<0.0001), mainly due to the cost of etanercept. Outpatient-care costs and loss-of-productivity costs decreased from 9,500 to 5,000 (p = 0.0002), and from 33,000 to 18,000 DKK (p = 0.0105), respectively. The decrease in costs was more pronounced in patients who also had psoriatic arthritis. Cost increase was greatest during the first 6 months. CONCLUSION: Etanercept treatment was associated with decreased psoriasis severity and improved quality of life. Cost increase was driven by medication, while costs of outpatient care and loss-of-productivity decreased. Maintained improved quality of life was accompanied by decreasing cost during the second 6 month period of etanercept treatment. There were no new safety signals reported.

The effect of UVB radiation on skin microbiota in patients with atopic dermatitis and healthy controls.

OBJECTIVES: To investigate Staphylococcus aureus and Staphylococcus epidermidis quantitatively in adult patients with atopic dermatitis and in healthy controls treated with UVB radiation. STUDY DESIGN: Twenty-three adult patients (of these, 3 were excluded) with flexural atopic dermatitis and 20 healthy controls were randomly selected at the outpatient clinic of the Dermatological Department, University Hospital, North Norway. METHODS: Adult patients with atopic dermatitis (n = 20) and healthy controls (n = 20) were given 20 UVB treatments. Bacterial samples were collected before treatment, after 4 weeks of treatment, and finally after 2 weeks follow-up. RESULTS: The main bacteria found were Staphylococcus aureus and Staphylococcus epidermidis. 16 of the 20 patients with atopic dermatitis had Staphylococcus aureus in lesional skin and 12 in non-lesional skin. None of the healthy controls had Staphylococcus aureus in the sample from the flexural elbow. The Staphylococcus aureus counts decreased (not significant) in lesional skin after 4 weeks of treatment and Staphylococcus aureus counts were slightly higher after 2 weeks follow up. The same figures were also seen in non-lesional skin and forehead. CONCLUSIONS: Staphylococcus aureus is widely colonised in the skin of atopic dermatitis patients, but is rare in healthy adults. UVB treatment decreases the Staphylococcus aureus count in patients with atopic dermatitis.

The prevalence of allergic contact sensitization in a general population in Tromsø, Norway.

OBJECTIVES: This study investigated the prevalence of contact sensitization in a general adult population and the relationship between the history of metal dermatitis and sensitization to metal allergens. STUDY DESIGN: A cross-sectional population study using patch tests and a questionnaire was conducted among adults in Tromsø, Northern Norway. METHODS: A random sample of 830 participants aged 18-75 years were invited to participate in the patch testing and completed a 1-page self-administered questionnaire. Of the adults, 531 (64%) were actually TRUE tested (using a standardized, ready-to-apply patch test system) and completed the self-administered questionnaire about ear piercing, metal reactions, skin reactions to different allergens, atopic dermatitis, eczema, cooking equipment and diet. RESULTS: The study showed that nickel (19.2%; women 31.1% and men 5.0%), fragrance mix (3.4%) and cobalt (1.7%) were the most prevalent allergens causing contact sensitization. For all other allergens, less than 1.1% tested positive. Eighty-four (45.2%) subjects with a positive history of metal dermatitis had negative patch tests. CONCLUSIONS: Contact sensitization was found frequently in this general adult population, especially to nickel and perfumes with a predominance among females. An eczematous reaction caused by cheap earrings seemed to be the best indicator for metal sensitivity.

Allergic contact sensitization in the general adult population: a population-based study from Northern Norway.

Few studies have so far addressed the prevalence and risk factors for contact sensitization in the general adult population; however, many such studies have been conducted in hospitals. We present the prevalence of contact sensitization in a general adult population and its relationship to potential risk factors like smoking, ear piercing and atopic diseases. 1236 adults (44.2% men and 55.8% women) were randomly selected from a cross-section of the population in Sør-Varanger municipality, Norway, and patch tested with TRUE Test (Pharmacia, Hillerød, Denmark). Contact sensitivity to at least 1 out of 24 allergens was found in 35.4% of the women and in 14.8% of the men. The most common allergens were nickel (17.6%), cobalt (2.8%), thiomersal (1.9%), fragrance mix (1.8%) and colophony (1.2%). All other allergens were observed in 1.0% or less. In women, ear piercing was an important risk factor for nickel sensitization. No such significant correlation was seen in men [in women relative risk (RR) = 3.30, 95% confidence interval (CI) = 2.01-5.43, and in men RR = 1.82, 95% CI = 0.66-5.00], and contact sensitivity was associated with atopic dermatitis (AD) [adjusted odds ratio (OR) = 1.58, 95% CI = 1.04-2.40] and smoking (adjusted OR = 1.42, 95% CI = 1.01-1.99) in women but not in men. The prevalence of contact sensitivity was common in this general population, especially in women. Smoking and AD might be a risk factor for contact sensitization.