Local use of a China-made compound betamethasone injection for the treatment of lichen simplex chronicus: a multi-center, randomized, parallel controlled clinical study / 中华皮肤科杂志

ABSTRACT

Objective To evaluate the safety and efficacy of single and local use of a China-made compound betamethasone injection in the treatment of lichen simplex chronicus. Methods A multi-center,randomized, parallel controlled study was conducted. Patients with lichen simplex chronicus were divided into test and control groups to receive a single dose of intralesional compound betamethasone injection made in China or Schering-Plough Labo N.V. Belgium. Patients were visited for the evaluation of efficacy and safety of the China-made injection at the beginning of the treatment (DO), on week 2 (D14) and 4 (D28) after the initiation of treatment. Results A total of 144 patients were enrolled, among which, 68 in the control group and 71 in the test group completed the trial. FAS analysis on week 4 revealed that the response rate and healing rate were 86.11% and 59.72% in the control group, respectively, 86.11% and 54.17% in the test group, respectively (χ2=0.00,0.45,respectively,both P>0.05).There was no severe adverse event in either group after the treatment, and only mild atrophoderma occurred in one patient in the control group, which was improved spontaneously within several weeks of follow-up. There was no statistically significant difference in the occurrence of side reactions between the two groups (P> 0.05). Conclusion The China-made compound betamethasone injection is effective and safe for the treatment of lichen simplex chronicus.