Comparison of different incremental dose regimens of narrow-band ultraviolet B in skin types III-V: a prospective, randomized, single-blind parallel study in patients with psoriasis
Supplemental Figure 1. Treatment regimen. Supplemental Table I. Inclusion and exclusion criteria Supplemental Table II. Protocol and adjustments Supplemental Table III. Patient characteristics at baseline Supplemental Table IV. Primary, ranked secondary, and additional endpoints Supplemental Table 5. Comparison of PASI 75 and PASI 90 response rate between patients with or without tendency for remission in summer
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Study design and setting This randomized, single-blind study was performed at the Shanghai Skin Disease Hospital, Shanghai, China. Patients and randomization Between September 1, 2019, and December 31, 2019, all adult patients (aged ≥18 years) with psoriasis who were referred for UVB phototherapy were invited to participate in this randomized clinical trial. Patients who met all criteria (n = 111) were randomly assigned (using a random number table) to receive 30 sessions of NB-UVB treatment with different incremental dosages: group 1 (n = 50) was assigned to receive 10% increments, group 2 (n = 50) to receive 20% increments, and group 3 (n = 11) to receive 30% increments. Patients were blinded to the treatment assignment until study completion. Treatment equipment A full-cabin ultraviolet light therapy device (SS-12B; Shanghai SIGMA High-Tech Co., Ltd., Shanghai, China) was used for treatment. This device is used routinely in our institute and has radiation intensity of 13.70 mW/cm2. Ethical compliance This study was approved by the local medical ethics committee (SSD-IEC-SG-029-3.0) and was registered in the Chinese Clinical Trial Registry (ChiCTR). All patients provided written informed consent before participation. Procedure For all patients, treatment was started with a dose of 500 mJ/cm2. .Treatment response was recorded at the end of sessions 5, 10, 15, 20, 25, and 30. Safety was monitored throughout the study.