A New Formulation of Collagenase Ointment (Iruxol?? Mono) in the Treatment of Ulcers of the Lower Extremities

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Abstract
The efficacy and tolerability of a new formulation of collagenase ointment (Iruxol® mono) was determined in a placebo-controlled randomised double-blind study. 30 patients with chronic ulcers of the lower extremities were treated with either Iruxol® mono or placebo ointment base for a minimum of 14 days. Treatment efficacy was determined by evaluating wound debridement, granulation, epithelisation and inflammation using 5-point scales and by measuring wound size. All parameters were assessed daily for the first 2 weeks of treatment and weekly thereafter. For all efficacy parameters, Iruxol® mono was significantly superior to placebo (p < 0.01). Differences reached statistical significance after 6 days of treatment for both debridement and inflammation, and after 4, 5 and 8 days for granulation, epithelisation and wound size, respectively. In addition to individual parameters, an investigator’s rating of clinical global efficacy also demonstrated the superiority of Iruxol® mono (p < 0.001).

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