Ciprofloxacin utility as antifibrotic in the skin of patients with scleroderma

Scleroderma is an autoimmune connective tissue disorder that is characterized by microvascular injury, excessive fibrosis of the skin, and distinctive visceral changes that can involve the lungs, heart, kidneys and gastrointestinal tract. To date, although several drugs have been used to reduce fibrosis in scleroderma, there exists no effective pharmacological treatment. To determine if oral ciprofloxacin reduces the severity of scleroderma, a controlled, double-blind randomized clinical trial, with placebo, was conducted on 32 patients with diffuse and limited scleroderma, who received oral ciprofloxacin (250 mg) or placebo every 12 h. Skin induration and thickness of the patients were clinically evaluated using the modified Rodnan skin score at the beginning and once per month during 6 months of treatment with ciprofloxacin. To monitor progression of the disease, a monthly hematological exam and clinical evaluation was done to explore renal and hepatic function for each patient. Thirty patients completed the study; one from the treatment group was excluded when presenting a skin reaction and another from the placebo group abandoned the study due to an exacerbation of disease. At the sixth month of the study, the ciprofloxacin group of patients showed a diminution in the modified Rodnan skin score (58% vs 18%, P = 0.003), showing no significant alterations in the laboratory assays in either groups of patients. Our results suggest that oral administration of ciprofloxacin for 6 months reduces the severity of symptoms affecting the skin of patients with systemic scleroderma, and does so without important secondary effects.