Heinlin, J. and Schiffner-Rohe, J. and Schiffner, R. and Einsele-Kraemer, B. and Landthaler, M. and Klein, A. and Zeman, F. and Stolz, W. and Karrer, Sigrid (2011) A first prospective randomized controlled trial on the efficacy and safety of synchronous balneophototherapy vs. narrow-band UVB monotherapy for atopic dermatitis. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 25 (7). pp. 765-773. ISSN 0926-9959, 1468-3083
Full text not available from this repository. (Request a copy)Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | AIR-CONDITIONED PHOTOTHERAPY; ULTRAVIOLET-B; DEAD-SEA; SALT-SOLUTIONS; TASK-FORCE; PSORIASIS; ECZEMA; BATHS; IRRADIATION; VALIDATION; atopic dermatitis; balneophototherapy; Dead Sea salt; narrow-band UVB therapy; phototherapy; SCORAD; TOMESA |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 08 Jun 2020 11:13 |
| Last Modified: | 08 Jun 2020 11:13 |
| URI: | https://pred.uni-regensburg.de/id/eprint/20596 |
Actions (login required)
 |
View Item |
