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Development of Collagenase Treatment for Dupuytren Disease
- Source :
- Hand Clinics. 34:345-349
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
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.
- Subjects :
- endocrine system
medicine.medical_specialty
Dupuytren disease
Drug Evaluation, Preclinical
Injections, Intralesional
03 medical and health sciences
0302 clinical medicine
Collagenase clostridium histolyticum
medicine
Clinical endpoint
Animals
Humans
Orthopedics and Sports Medicine
030212 general & internal medicine
Muscle contracture
Clinical Trials as Topic
030222 orthopedics
United States Food and Drug Administration
business.industry
United States
Tendon
Surgery
Dupuytren Contracture
Microbial Collagenase
medicine.anatomical_structure
Collagenase
Contracture
medicine.symptom
Clostridium histolyticum
business
medicine.drug
Subjects
Details
- ISSN :
- 07490712
- Volume :
- 34
- Database :
- OpenAIRE
- Journal :
- Hand Clinics
- Accession number :
- edsair.doi.dedup.....9bb740041e9b661d7dfc66227e833ca1