Efficacy and safety of ANGIPARSTM for the treatment of skin manifestations of scleroderma:a phase 2 clinical trial

Abstract

Objective: We aimed to evaluate the safety and efficacy of ANGIPARS™ in a phase 2 clinical trial. Methods: This study was performed as a phase 2 clinical trial without a control group between May 2007 and September 2008 in the Iranian Rheumatology Research Center on a group of volunteer patients that were diagnosed with scleroderma. Patients with the diagnosis of diffuse or limited scleroderma without the involvement ofinternal organs were given 100 mg ANGIPARSTM capsules three times a day for 6 months, followed by 2 capsules a day for a further 3 months. Follow-up continued for a year. At the baseline, modified Rodnan score, pain severity and number of pitting ulcers, number of perioral folds, finger to palm distance, and open- mouth area were assessed in each patient. The measurements were repeated on a monthly basis and their change from the baseline was calculated. Possible adverse effects were monitored at regular monthly intervals through a complete set of laboratory tests and clinical examination. Results: Eleven patients including 10 females were recruited. The mean age was 39 years (SD = 10.2). No significant changes and no abnormality in laboratory measures were found during the study. Repeated measure analysis revealed a significant reduction in the modified Rodnan score (Mean reduction= 38%, P value < 0.001), finger to palm distance and number of pitting ulcers (mean reduction 33% & 87.5%, respectively, and P values < 0.001 & 0.003, respectively), and an increase in open-mouth area (mean reduction = 20.6%, P value = 0.041). The drug had no effect the pain of the ulcers or on the perioral folds. Conclusion: ANGIPARSTM is efficient and safe for the treatment of the skin manifestations of scleroderma. Conducting a phase III placebo controlled randomized trial is recommended.