Abstract
BackgroundTo determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules.MethodsIn this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end.ResultsIn the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (−80.1%, P = 0.0002) and CCH 0.60 mg (−78.2%, P = 0.0003), but not CCH 0.25 mg (−58.3%, P = 0.079), versus placebo (−42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were “very satisfied” or “quite satisfied” with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment.ConclusionIn patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture.Trial registrationClinicalTrials.gov identifier: NCT02193828. Date of trial registration: July 2, 2014 to December 5, 2014
Highlights
To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules
Patient population Patients ≥18 years of age with Dupuytren disease who had ≥1 palpable palmar nodule that was not associated with a cord and measured between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in width were eligible for inclusion in the study
At Week 8, significant differences versus placebo were observed in caliper-measured nodular surface area for CCH 0.60 mg (P = 0.0003) and CCH 0.40 mg (P = 0.0002), but not with CCH 0.25 mg (P = 0.08; Fig. 2) Ultrasound measurements of nodule size did not correlate with direct caliper measurements and were, considered an unreliable assessment of treatment efficacy and not reported for this study
Summary
To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules. Dupuytren disease is a common fibroproliferative disease of the palmar fascia [1] that is reported to affect between 1% and 32% of individuals in Western countries [2, 3]. It is characterized by the formation of thick collagen nodules that can progress to fibrous cords capable of producing digital flexion contractures and reducing hand function [4]. In the early proliferative phase, nodules form as myofibroblasts and proliferate around microvessels [5] This myofibroblast proliferation may lead to vessel occlusion and hypoxia, and signal infiltration of immune cells [5]. Nodules have been replaced by fibrous cords, which can shorten and cause further contracture [4]
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