A new formulation of collagenase ointment (iruxol((r)) mono) in the treatment of ulcers of the lower extremities: a randomised, placebo-controlled, double-blind study.
The efficacy and tolerability of a new formulation of collagenase ointment (Iruxol((R)) 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((R)) 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((R)) 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((R)) mono (p < 0.001). Iruxol((R)) mono and placebo were both well tolerated. Adverse events were minor and consisted of a burning sensation following ointment application in 3 patients in each group and erythema in a further 2 patients in each group. There were no withdrawals as a result of adverse events in either group. The relationship between adverse event and treatment was considered unlikely in all cases. In conclusion, Iruxol((R)) mono was significantly superior to placebo in all estimates of efficacy in wound healing. Iruxol((R)) mono was well tolerated with an adverse event profile similar to that of placebo.
Palmieri
B
B
University of Modena, Clinica Chirurgica I, Modena, Italy.
Magri
M
M