Collagenase clostridium histolyticum

Generic Name: Collagenase clostridium histolyticum

Brand Names: Qwo, Santyl, Xiaflex

Drug Type: Biotech

CAS Number: 9001-12-1

Unique Ingredient Identifier: 9X7O8V25IT

Background: Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum. It is beneficial in the breakdown of collagen plaques for the treatment of Dupuytren's contracture and Peyronie's disease. The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers.

On July 6, 2020 a combination of injectable bacterial collagenases was approved by the FDA for the treatment of cellulite in adult women. Also known as Qwo, this injection is the first approved injectable treatment for cellulite and was developed by Endo International.

Indication: Collagenase clostridium histolyticum is indicated for the treatment of adults with Dupuytren's contracture with a palpable cord. Additionally, it is used to treat men with Peyronie's disease diagnosed with a penile curvature deformity of at least a 30-degree angle at the beginning of therapy in addition to palpable plaques. Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues.

The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.

Associated Conditions: Dupuytren's Contracture of the Hand (Viking's Disease), Peyronie's Disease, Necrotic tissue

Clinical Trials

Injection Techniques of Collagenase Clostridium Histolyticum (CCH) for the Treatment of EFP (Cellulite)

Phase 2

Completed

Conditions: Edematous Skin

Interventions: Drug: collagenase clostridium histolyticum (CCH)

First Posted Date: 2018-08-16

Last Posted Date: 2023-09-07

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 64

Registration Number: NCT03632993

Locations: 🇺🇸
Endo Clinical Trial Site #4, New York, New York, United States
🇺🇸
Endo Clinical Trial Site #1, Coral Gables, Florida, United States
🇺🇸
Endo Clinical Trial Site #5, Miami, Florida, United States

and more 2 locations

Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease

Phase 4

Active, not recruiting

Conditions: Dupuytren Disease of Finger

Interventions: Procedure: Fasciectomy
Drug: Collagenase Clostridium Histolyticum

First Posted Date: 2018-01-23

Last Posted Date: 2025-04-16

Lead Sponsor: Region Skane

Target Recruit Count: 60

Registration Number: NCT03406338

Locations: 🇸🇪
Department of Orthopedics Hässleholm-Kristianstad, Hässleholm, Sweden

Trial Comparing Treatment Strategies in Dupuytren's Contracture

Phase 4

Active, not recruiting

Conditions: Dupuytren Contracture

Interventions: Procedure: Percutaneous needle fasciotomy (PNF)
Drug: Collagenase Clostridium Histolyticum (CCH) 2.9 MG/ML [Xiaflex]
Procedure: Limited fasciectomy (LF)

First Posted Date: 2017-06-19

Last Posted Date: 2025-03-26

Lead Sponsor: Tampere University

Target Recruit Count: 302

Registration Number: NCT03192020

Locations: 🇫🇮
Tampere University Hospital, Tampere, Pirkanmaa, Finland
🇫🇮
Oulu University hospital, Oulu, Pohjois-Pohjanmaa, Finland
🇫🇮
Kuopio University hospital, Kuopio, Pohjois-Savo, Finland

and more 3 locations

Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Phase 4

Conditions: Dupuytren Contracture
Dupuytren's Disease of Finger

Interventions: Procedure: Percutaneous Needle Aponeurotomy
Drug: XIAFLEX

First Posted Date: 2016-12-21

Last Posted Date: 2016-12-21

Lead Sponsor: University of Calgary

Target Recruit Count: 334

Registration Number: NCT03000114

Locations: 🇨🇦
University of Calgary, Calgary, Alberta, Canada

Clostridium Histolyticum Collagenase Injection for Urethral Disease

Phase 2

Completed

Conditions: Urethral Stricture

Interventions: Drug: Clostridium Histolyticum Collagenase
Other: Saline

First Posted Date: 2016-10-28

Last Posted Date: 2023-11-03

Lead Sponsor: University of South Florida

Target Recruit Count: 5

Registration Number: NCT02948842

Locations: 🇺🇸
University of South Florida - South Tampa Campus, Tampa, Florida, United States

Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)

Phase 1

Completed

Conditions: Fibroids, Uterine
Leiomyoma

Interventions: Other: Saline
Drug: EN3835

First Posted Date: 2016-09-07

Last Posted Date: 2019-07-10

Lead Sponsor: Advance Biofactures Corporation

Target Recruit Count: 15

Registration Number: NCT02889848

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

Phase 3

Completed

Conditions: Dupuytren's Disease

Interventions: Procedure: limited palmar fasciectomy
Drug: collagenase injection

First Posted Date: 2016-04-01

Last Posted Date: 2023-07-18

Lead Sponsor: McMaster University

Target Recruit Count: 22

Registration Number: NCT02725528

Locations: 🇨🇦
Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦
Halton Healthcare Services, Oakville, Ontario, Canada
🇨🇦
St. Joseph's Healthcare, London, Ontario, Canada

and more 7 locations