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

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.