John Libbey Eurotext

European Journal of Dermatology

Dead Sea treatment - principle for outpatient use in atopic dermatitis: safety and efficacy of synchronous balneophototherapy using narrowband UVB and bathing in Dead Sea salt solution Volume 12, issue 6, November - December 2002

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Authors
Department of Dermatology, University of Regensburg, 93042 Regensburg, Germany.
  • Key words: atopic dermatitis, narrowband UVB, outpatient balneophototherapy, according-to-protocol, intention-to-treat, Dead Sea salt.
  • Page(s) : 543-8
  • Published in: 2002

Safety and efficacy of this new treatment modality for out-patients were evaluated by an uncontrolled multicenter trial under GCP-conditions. Patients had to undergo 3-5 treatment sessions per week up to 35 in total. SCORAD (SC) was assessed at baseline, after 20 and 35 sessions. For patients with early study withdrawal the last-observation-carry-forward-principle was used. 615 intention-to-treat (itt)- (baseline SC: 59.4) and 143 according-to-protocol (atp)-patients (baseline SC: 60.1) could be analysed. 289 patients (47%) (baseline SC: 59.1) underwent less than 35 sessions. Main reasons were: lack of time (16%), non-compliance (12%), good improvement (7%), lack of efficacy (6%), intercurrent disease (4%) and side effects (3%). Mean number of sessions in atp-group was 35, in itt 26, and in patients with early study withdrawal 15.8. SC decreased in atp-group to 37.5 (itt: 44.5/patients with early study withdrawal: 46.1) after 20 sessions and to 27.1 (35.2/42.6) at end of treatment. Relative SC-improvement was statistically significant in atp- (55%), itt-group (41%), and in patients with early study withdrawal (26%). Most frequent side effects were: erythema in 7.3%, burning of skin due to salt solution in 3.6%. Safety and efficacy could be proven in both atp- and itt-group. A marked difference in efficacy between atp and itt underlines the importance of evaluating itt-data providing a more realistic assessment of a treatment modality in practice. This treatment is especially recommended for patients with chronic type of AD, high compliance and time free for therapy.