Topical putrescine (Fibrostat) in treatment of hypertrophic scars: phase II study.

Abstract

Previous studies indicated that tissue transglutaminase plays a role in the cross-linking of type III procollagen in wound matrices and that this may be inhibited by 50 mM putrescine in vitro. For this reason, the clinical effect of 50 mM putrescine in a eutectic vehicle (Fibrostat) was studied in this phase II double-blind crossover study in 43 patients. Twenty of the patients had had recent surgery and were studied for product safety rather than efficacy. No toxic effects were observed in this group of patients, and only 1 of the 23 unoperated patients had a rash during treatment. The observed effect of Fibrostat versus sham treatment of 1 month's duration in active hypertrophic scar was a significant improvement of hypertrophy in 23 patients during the Fibrostat treatment arm, regardless of the order in which treatment was received. It is suggested that Fibrostat is a safe therapeutic agent for treatment of hypertrophic scar. Clinical examples to illustrate its use are given.