TY - JOUR ID - 40674 TI - Efficacy and safety of ANGIPARS for the treatment of skin manifestations of scleroderma:a phase 2 clinical trial JO - Rheumatology Research JA - RR LA - en SN - AU - Gharibdoost, Farhad AU - Faezi, Seyedeh Tahereh AU - Khorram Khorshid, Hamidreza AU - Kamali, Kourosh AU - Solaymani-dodaran, Mohammad AU - Chaman, Reza AD - Rheumatology Research Centre, Tehran University of Medical Sciences, Tehran, Iran AD - Genetic Research Centre, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran AD - Reproductive Biotechnology Research Centre, Avicenna Research Institute (ACECR), Tehran AND Department of Public Health, School of Public Health, Zanjan University of Medical Sciences, Zanjan, Iran AD - Department of Epidemiology and Biostatics, School of Public Health and Institute of Public Health Research, Tehran University of Medical Sciences, Tehran, Iran AD - Department of Community Medicine, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran Y1 - 2016 PY - 2016 VL - 1 IS - 1 SP - 3 EP - 9 KW - scleroderma KW - Rodnan score KW - skin manifestation KW - pitting ulcer KW - ANGIPARSTM DO - 10.22631/rr.2016.40674 N2 -  We aimed to evaluate the safety and efficacy of ANGIPARS™ in a phase 2 clinical trial. 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. 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. ANGIPARSTM is efficient and safe for the treatment of the skin manifestations of scleroderma. Conducting a phase III placebo controlled randomized trial is recommended. UR - https://www.rheumres.org/article_40674.html L1 - https://www.rheumres.org/article_40674_52425627a57dd6a7c6bc063a163e9816.pdf ER -