It trended toward greater improvement in mean change in pain.
Presented results showed collagenase clostridium histolyticum may improve nodular hardness, nodular consistency and investigator assessment in patients with plantar fibromatosis.
In addition, collagenase clostridium histolyticum (Xiaflex, Endo Inc.) also trended toward greater pain reduction.
"The safety profile of the [collagenase clostridium histolyticum] CCH in this study was consistent with the known safety profile of CCH," Jason Levy, DPM, FACFAS, of DMI Research, said in his presentation at the American Orthopaedic Foot & Ankle Society Annual Meeting. "The results warrant further investigation, and phase 3 trials are currently underway."
Levy and colleagues randomly assigned 166 patients with plantar fibromatosis and one to three "moderately firm" to "hard" nodules per affected foot to receive either CCH (n = 83) or placebo (n = 83) treatment administered at day 1 and day 29.
Levy said the primary efficacy endpoint was pain improvement, with a mean change from baseline to day 57 using the Foot Function Index (FFI) scale. He added the secondary endpoint was mean change in baseline from days 15, 29, 43 and 57 with the FFI pain scale and a mean change from baseline to day 57 in nodular hardness, nodular consistency and investigator assessment of the clinical global impression of change scale.
According to Levy, patients in the CCH group trended toward greater improvement in mean change in pain from baseline to day 57, but the result was not statistically significant. Patients in the CCH group also showed continued improvement in FFI pain subscale by visit through day 57, with a trend toward greater improvement in the CCH group vs. the placebo group at days 43 and 57, he said. However, Levy said this endpoint was not statistically significant.
"There was a statistical significance or a decrease in the main nodular hardness from baseline to day 57 for everyone in the CCH group over placebo, which was statistically significant, with a nominal P value of .02 for hardness by durometer," Levy said.
Levy added patients in the CCH group had a statistically significant change in firmness at day 57 (P = .002).
"The investigator assessment of improvement with the clinician global impression of change scale [showed] there were 14.8% more responders in the CCH group vs. placebo at day 57," Levy said. "This was statistically significant with a nominal P value of .04."