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

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.