A randomized clinical trial in psoriasis: synchronous balneophototherapy with bathing in Dead Sea salt solution plus narrowband UVB vs. narrowband UVB alone (TOMESA-study group).

BACKGROUND: Synchronous balneophototherapy (sBPT) simulates treatment conditions at the Dead Sea for outpatient use. In the past, sBPT proved to be an effective treatment for psoriasis. However, there is a lack of sufficiently large randomized controlled clinical trials evaluating the additional benefit of sBPT compared with ultraviolet B (UVB) monotherapy. OBJECTIVES: The purpose of this study was to compare the effectiveness and safety of sBPT with UVB phototherapy (PT) alone in a randomized controlled effectiveness study. METHODS: In this phase III, multicentre effectiveness study, 367 patients with moderate to severe psoriasis were randomly allocated in a 1 : 1 ratio to receive either sBPT consisting of narrowband UVB PT with 311 nm and synchronous bathing in 10% Dead Sea salt solution or PT with 311 nm alone. Primary endpoint, analysed on an intention-to-treat basis (n = 356), was the relative improvement of the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment (35 sessions or clearance). Sample size calculation aimed at the detection of superiority of at least 10%. RESULTS: Median PASI values were comparable at baseline (sBPT: 15.1, interquartile range: 10.9-24.3; PT: 15.3, interquartile range: 10.0-23.7). A clinically relevant and statistically significant difference of 49.5% between sBPT and PT could be proven at the end of the therapy phase (P < 0.001; Wilcoxon-Mann-Whitney test). Exploratory testing showed a statistically significant superiority of sBPT after 6 months. CONCLUSIONS: In routine clinical practice, sBPT is superior to PT alone after 35 treatment sessions and a follow-up of 6 months. Both treatments demonstrated to be safe.

A first prospective randomized controlled trial on the efficacy and safety of synchronous balneophototherapy vs. narrow-band UVB monotherapy for atopic dermatitis.

BACKGROUND: Data from an uncontrolled trial suggest synchronous balneophototherapy (sBPT), which simulates treatment conditions at the Dead Sea, to be effective in the management of atopic dermatitis (AD). OBJECTIVES: The purpose of this prospective randomized controlled study was to compare the efficacy and safety of sBPT with narrow-band (NB) UVB monotherapy (PT) for AD. METHODS: In this phase III multicentre trial, 180 patients with moderate-to-severe AD were allocated to two groups in a 1:1 ratio; group 1 received sBPT consisting of NB UVB treatment and synchronous bathing in 10% Dead Sea salt solution, group 2 monotherapy with UVB 311 nm. The confirmatory study design consisted of up to 35 treatment sessions. Primary endpoint, analysed on an intention-to-treat-basis (n=169), was the relative improvement of the severity SCORing of the Atopic Dermatitis Index (SCORAD) from baseline to the end of treatment (35 sessions or early cure). Sample-size calculation aimed at establishing at least 15% superiority. RESULTS: SCORing of the Atopic Dermatitis Index at baseline was comparable between sBPT (61.8±14.1) and PT (61.5±12.4) group. At the end of therapy, a clinically relevant and statistically significant difference of 26.2% could be shown (P<0.001). Exploratory testing showed statistically significant superiority of sBPT after 6 months. Mild adverse events more frequently occurred in the sBPT group (n=46, PT: n=31), whereas more patients withdrew early because of adverse events in the PT group (n=6, sBPT: n=2). CONCLUSIONS: A clear advantage of sBPT in comparison to PT was proven. Tolerability was comparable; both treatments showed to be safe.

Long-term dermoscopic follow-up of melanocytic naevi: clinical outcome and patient compliance.

BACKGROUND: Digital dermoscopy for the follow-up of melanocytic naevi (MN) is becoming more common in dermatological private practice. OBJECTIVES: To evaluate the clinical outcome, including the patient's compliance, in a long-term follow-up of single MN. METHODS: Criteria for the selection of MN for follow-up: clinically suspicious without dermoscopically atypical features, or typical for the patient. Clinical outcome measures: number of detected malignant melanomas (MM) and/or atypical MN; quantity, quality, and differences in morphological changes between 'low-risk' patients (no MM in history and < 50 MN) and 'high-risk' patients (MM in history and/or > 50 MN). Compliance: the number of patients who joined a recommended follow-up scheme. RESULTS: No MM was found in 145 consecutive patients (mean age 28 years, 54% female) during a 4-year period (median follow-up per patient: 24 months; ranging 4-45; at least three visits). In five patients (3%), seven histologically proven atypical MN were shown on whole body examination at sites other than those documented. A total of 1968 images in 177 'low-risk' and 95 'high-risk' MN were analysed: 37% (n = 65) of 'low-risk' and 32% (n = 30) of 'high-risk' MN showed dermoscopic changes (difference not statistically significant), none were suspicious for MM. Compliance, evaluated within a separate database of 303 consecutive patients (mean age 32 years, 52% female) over a 6-month period, was only 46%, although recall letters were used. CONCLUSIONS: (i) In our setting of daily routines in dermatological private practices long-term follow-up of a single MN seems not to be helpful for the detection of MM. (ii) A whole body examination must be done at each visit. (iii) The clinician's experience of the type and number of possible morphological changes in MN is crucial in order to avoid unnecessary excisions. (iv) The patient's compliance might be an important problem. (v) Cost-effectiveness has yet to be analysed.

Improvement of early recognition of lentigo maligna using dermatoscopy.

BACKGROUND: The clinical differentiation between lentigo senilis/initial seborrheic keratosis and lentigo maligna on the face can be difficult. OBJECTIVE: Our purpose was to determine whether dermatoscopy (eg, skin surface microscopy at 10x magnification) can reliably differentiate between these entities. METHODS: Dermatoscopic slides of 87 consecutive patients presenting 37 malignant and 50 benign pigmented skin lesions on the face were analyzed with the use of 27 dermatoscopic criteria. RESULTS: Univariate analysis selected two criteria specific for lentigo maligna: asymmetric pigmented follicular openings and dark (brown or black) rhomboidal structures. Location-specific importance in relation to facial location was attributed to the color "slate-gray, " especially in combination with structures such as dots, globules, streaks, and homogeneous areas. Multivariate analysis (logistic regression model) revealed the 4 most important features to be asymmetric pigmented follicular openings, dark rhomboidal structures, slate-gray globules, and slate-gray dots with a sensitivity of 89% and a specificity of 96%. CONCLUSION: Three conclusions can be drawn from our study: With a set of 4 dermatoscopic features, early lentigo maligna can be detected with high accuracy; dermatoscopic features on the face differ from criteria used in other locations; and our progression growth model for lentigo maligna delineates the different steps of malignant growth in lentigo maligna.

Cost effectiveness of micronised fenofibrate and simvastatin in the short-term treatment of type IIa and type IIb hyperlipidaemia.

The aim of this study was to compare the cost effectiveness of micronised fenofibrate 200 mg and simvastatin 20 mg in the treatment of type IIa and IIb hyperlipidaemia. In a retrospective analysis, data from 2 randomised controlled clinical trials were evaluated. The results show that micronised fenofibrate has a better short term cost effectiveness than simvastatin. The costs per successfully treated patient with hyperlipidaemia over a 12-week period were [in Deutschmarks (DM); DMI = $US0.66, April 1995] DM537 for fenofibrate and DM809 for simvastatin. When the data were analysed according to type of hyperlipidaemia (classification of Frederickson), there were only small differences between both test drugs (DM450 for fenofibrate, DM517 for simvastatin) in patients with type IIa because simvastatin had higher response rates which, in part, compensated for the higher acquisition cost. However, response rates in patients with type IIb hyperlipidaemia were higher for fenofibrate, which led to a substantial cost advantage for this agent (DM768 for fenofibrate, DM2080 for simvastatin). These results were confirmed by various sensitivity analyses, including the assessment of drug monitoring programmes (postmarketing surveillance) to validate response rates and the total costs of the therapy. In this study, we evaluated the total costs of a 12-week period of therapy, not the costs per day. The results are based on actual clinical data and not just on theoretical models. The study underlines the necessity to differentiate between the types of hyperlipidaemia when performing a pharmacoeconomic analysis of lipid-lowering treatments.