Development of Collagenase Treatment for Dupuytren Disease.

Abstract

Proof-of-principle, basic-science studies, using a rat-tail tendon model and surgically removed Dupuytren cords, began collagenase Clostridium histolyticum (CCH) development. Clinical studies in humans were then conducted, where the primary endpoint was reduction in contracture to within 0° to 5° of extension. Phase 2 studies, which confirmed the optimal dose of collagenase as 0.58 mg, showed injectable CCH reduced contractures in MP and PIP joints to within 0° to 5° in many joints and was well tolerated. Clinical results from phase 3 studies confirmed the efficacy and safety of injectable CCH as a viable nonsurgical intervention.

• Authors: Marie A Badalamente, Lawrence C Hurst
• Journal: Hand clinics (Hand Clin) Vol. 34 Issue 3 Pg. 345-349 (08 2018) ISSN: 1558-1969 [Electronic] United States
• PMID: 30012294 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Microbial Collagenase

Topics

• Animals
• Clinical Trials as Topic
• Clostridium histolyticum (enzymology)
• Drug Evaluation, Preclinical
• Dupuytren Contracture (drug therapy)
• Humans
• Injections, Intralesional
• Microbial Collagenase (therapeutic use)
• United States
• United States Food and Drug Administration