A 5-year safety and efficacy evaluation with fibrel in the correction of cutaneous scars following one or two treatments.

In a multicenter clinical trial 300 patients were treated with Fibrel, 4 weeks following a negative skin test, for the correction of cutaneous scars. Fibrel treatment was restricted to one or two implants in a maximum of four scars. The scar corrections were evaluated by the physician, the patient, and also via an objective photogrammetric method. At the end of 1 year the percentage of scars with moderate, marked, or complete correction were 65, 63.3, and 85.8% according to physician, patient, and photogrammetric evaluations, respectively. A cohort of 111 patients were followed for up to 2 years and 87 patients were followed up to 5 years postimplantation. The physician and patient evaluations showed 55.1 and 50.6%, respectively, of the scars in the moderate, marked, or complete correction category at the end of 5 years with only one or two treatments. Safety evaluations included tests for antinuclear antibodies, rheumatoid factor, and presence of antibodies to Fibrel and their crossreactivity to human collagen I and III. These tests did not show any causal relationship to Fibrel treatments and the patients did not have any untoward immunologic symptoms. The data from these patients demonstrate that one or two Fibrel treatments are effective in maintaining greater than 50% correction of depressed cutaneous scars up to 5 years with negligible adverse sequelae and no untoward immunologic symptoms.