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

Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's

Phase 4

Active, not recruiting

Conditions: Peyronie's Disease

Interventions: Procedure: Penile Plication Surgery
Drug: Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
Device: RestoreX Penile Traction Device
Procedure: Incision and Grafting (I&G) Surgery

First Posted Date: 2021-03-08

Last Posted Date: 2025-02-13

Lead Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Target Recruit Count: 40

Registration Number: NCT04786106

Locations: 🇺🇸
The Male Fertility and Peyronie's Clinic, Orem, Utah, United States

CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques

Phase 2

Completed

Conditions: Cellulite
Edematous Fibrosclerotic Panniculopathy
Laxity; Skin

Interventions: Drug: collagenase clostridium histolyticum

First Posted Date: 2020-10-08

Last Posted Date: 2022-09-28

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 35

Registration Number: NCT04580303

Locations: 🇺🇸
Endo Clinical Trial Site #2, Metairie, Louisiana, United States
🇺🇸
Endo Clinical Trial Site #3, Coral Gables, Florida, United States
🇺🇸
Endo Clinical Trial Site #1, New York, New York, United States

Safety and Efficacy of EN3835 in Participants With Frozen Shoulder

Phase 2

Completed

Conditions: Frozen Shoulder
Adhesive Capsulitis

Interventions: Drug: EN3835
Drug: Placebo

First Posted Date: 2020-08-03

Last Posted Date: 2023-09-13

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 198

Registration Number: NCT04496167

Locations: 🇺🇸
Endo Clinical Trial Site #6, Dayton, Ohio, United States
🇺🇸
Endo Clinical Trial Site #9, Mobile, Alabama, United States
🇺🇸
Endo Clinical Trial Site #1, Fort Lauderdale, Florida, United States

and more 35 locations

Histopathology Following CCH Injection

Phase 2

Completed

Conditions: Characteristics of Subcutaneous Tissue

Interventions: Drug: Collagenase Clostridium Histolyticum Single Injection Technique
Drug: Collagenase Clostridium Histolyticum Multiple Injection Technique

First Posted Date: 2020-01-22

Last Posted Date: 2022-04-12

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 10

Registration Number: NCT04236635

Locations: 🇺🇸
Endo Clinical Trial Site #1, Montclair, New Jersey, United States
🇺🇸
Endo Clinical Trial Site #2, New York, New York, United States

Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Women

Phase 2

Terminated

Conditions: Cellulite
Edematous Fibrosclerotic Panniculopathy (EFP)

Interventions: Drug: EN3835

First Posted Date: 2019-12-24

Last Posted Date: 2021-10-07

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 7

Registration Number: NCT04209530

Locations: 🇺🇸
Endo Clinical Trial Site #1, Coral Gables, Florida, United States

Real World CCH Study in Adult Females With Cellulite

Phase 3

Completed

Conditions: Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite

Interventions: Drug: EN3835

First Posted Date: 2019-11-20

Last Posted Date: 2022-02-22

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 153

Registration Number: NCT04170296

Locations: 🇺🇸
Endo Clinical Trial Site #9, Westport, Connecticut, United States
🇺🇸
Endo Clinical Trial Site #3, Chicago, Illinois, United States
🇺🇸
Endo Clinical Trial Site #11, Itasca, Illinois, United States

and more 9 locations

Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures

Early Phase 1

Terminated

Conditions: Collagenosis
Stricture
Anastomotic
Esophageal Stricture

Interventions: Drug: Collagenase histiolyticum

First Posted Date: 2019-04-02

Last Posted Date: 2023-09-13

Lead Sponsor: University Hospital, Ghent

Target Recruit Count: 2

Registration Number: NCT03898661

Locations: 🇧🇪
Hindryckx, Zwijnaarde, Belgium

Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

Phase 4

Completed

Conditions: Peyronie's Disease (PD)

Interventions: Drug: Xiaflex®
Drug: Aveed

First Posted Date: 2019-01-24

Last Posted Date: 2020-12-31

Lead Sponsor: Men's Health Boston

Target Recruit Count: 20

Registration Number: NCT03815331

Locations: 🇺🇸
Men's Health Boston, Chestnut Hill, Massachusetts, United States

Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response

Phase 4

Conditions: Peyronie's Disease

Interventions: Drug: Xiaflex® 0.58 mg

First Posted Date: 2018-12-06

Last Posted Date: 2018-12-07

Lead Sponsor: Manhattan Medical Research Practice, PLLC

Target Recruit Count: 20

Registration Number: NCT03767452

Locations: 🇺🇸
Manhattan Medical Research Practice, PLLC, New York, New York, United States

Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds

Not Applicable

Terminated

Conditions: Wounds and Injuries
Granulation Tissue
Wound Healing

Interventions: Biological: Collagenase Ointment
Device: Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

First Posted Date: 2018-10-29

Last Posted Date: 2024-10-16

Lead Sponsor: KCI USA, Inc

Target Recruit Count: 44

Registration Number: NCT03722485

Locations: 🇺🇸
University of Arizona, Tucson, Arizona, United States
🇺🇸
Northwell Health System - North Shore University Hospital, Manhasset, New York, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 7 locations

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