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

Authors: Heinlin J (1,2) , Schiffner-Rohe J (2) , Schiffner R (2) , Einsele-Krämer B (2) , Landthaler M (2) , Klein A (2) , Zeman F (1) , Stolz W (3) , Karrer S (2)

Affiliations:

(1) Center for Clinical Studies, University Hospital Regensburg (2) Department of Dermatology, University of Regensburg (3) Clinic of Dermatology, Hospital Schwabing

Source: J Eur Acad Dermatol Venereol. 2011 Jul;25(7):765-73

DOI: 10.1111/j.1468-3083.2010.03857 Publication date: 2010 E-Publication date: Oct. 3, 2010 Availability: abstract Copyright: © 2010 The Authors. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.

Language: English Countries: Germany Location: Not specified Correspondence address: S. Karrer. E-mail: sigrid.karrer@klinik.uni-regensburg.de

Keywords

Article 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.

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