title: 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.
abstract: 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.
authors.affiliation: Department of Dermatology, University of Regensburg, Germany. jr.schiffner@t-online.de
authors.forename: Roman
authors.initials: R
authors.lastname: Schiffner
authors.forename: Julia
authors.initials: J
authors.lastname: Schiffner-Rohe
authors.forename: Marco
authors.initials: M
authors.lastname: Gerstenhauer
authors.forename: Michael
authors.initials: M
authors.lastname: Landthaler
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Hofstädter
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Stolz
mesh_terms: D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D001452:Balneology / Q000379:methods*; D003131:Combined Modality Therapy; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D010349:Patient Compliance; D018579:Patient Selection; D012492:Salts / Q000627:therapeutic use; D016896:Treatment Outcome; D014467:Ultraviolet Therapy / Q000379:methods*
chemical_list: D012492:Salts