Treatment of progressive systemic sclerosis using factor XIII.

A double-blind, randomized crossover trial was carried out in 25 patients with progressive systemic sclerosis to compare the effectiveness and tolerability of treatment with Factor XIII with that of placebo. Patients received twice daily intravenous injections of either Factor XIII or placebo for 3 weeks and, after a wash-out period of 6 weeks, were crossed over to the alternative medication for a further 3 weeks. Assessments made by the physician and patients at the end of each treatment period indicated that Factor XIII was significantly better than placebo in improving the cutaneous manifestations of the disease and these opinions were supported by the significant improvement in the function index which was used to assess the degree of motor disability. Both local and general tolerability of Factor XIII treatment was good and there were no adverse reports.