Evaluation of a multicentre study of synchronous application of narrowbandultraviolet B phototherapy (TL-01) and bathing in Dead Sea salt solution for psoriasis vulgaris

The synchronous application of narrowband UVB phototherapy with 311 nm lamp s (Philips TL-01) and bathing in Dead Sea salt solution was evaluated in a multicentre trial (n = 60) in outpatients suffering from psoriasis vulgaris . The study design consisted of an initial therapy phase of up to 35 treatm ents (three to five times a week) followed by maintenance therapy with up t o 35 Further applications (once or twice a week). Evaluation Mras performed separately For patients in according-to-protocol (ATP) (n = 280) and inten tion-to-treat (ITT) (n = 692) groups. An overall significant improvement of the Psoriasis Area and Severity Index (PASI) score (P < 0.05) could be sho wn for both groups during initial therapy with 71.4% improvement for ATP an d 61% for ITT patients. The mean PASI for ATP (values for ITT in parenthese s) was 17.7 (18.6) at baseline, 9.5 (10.7) after 20 applications and 5.2 (7 .4) at the end of initial therapy. On average, ATP patients received 3.9 (3 .5) applications per week with a cumulative irradiation dose of 19.5 J cm(- 2) (16.2 J cm(-2)). The most frequent side-effect was erythema, observed in 8.7% of the patients. Subjective evaluation of the therapy by the patients (n = 168) was excellent. Seventy-nine per cent of patients preferred the n ew treatment strategy in comparison with other previous therapies and 88% r egarded this therapy as pleasant and comfortable. In conclusion, we could d emonstrate a significant effect of therapy in both the ATP and the ITT grou ps for this new treatment system which imitates, as far as possible, the De ad Sea climatic conditions, with no severe side-effects and a high acceptan ce by the patients.